<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03257085</url>
  </required_header>
  <id_info>
    <org_study_id>CALIBER</org_study_id>
    <nct_id>NCT03257085</nct_id>
  </id_info>
  <brief_title>CALIBER Phase 1: A Pilot Study in Normal-weight and Overweight Adults.</brief_title>
  <acronym>CALIBER</acronym>
  <official_title>CALIBER (Carbohydrates, Lipids and Biomarkers of Traditional and Emerging Cardiometabolic Risk Factors) Phase 1: A Pilot Study in Normal-weight and Overweight Adults.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Liverpool John Moores University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Liverpool Hope University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Liverpool John Moores University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Pilot study to compare the impact of following a low-carbohydrate, high-fat diet versus&#xD;
      following a high-carbohydrates, moderate-fat diet (UK dietary guidelines) on cardiometabolic&#xD;
      risk markers and associated behaviours in a normal-weight and overweight adult population.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Cardiometabolic diseases (CMD), such as type 2 diabetes and cardiovascular disease (CVD), are&#xD;
      globally amongst the highest contributors to morbidity and mortality with high (cost)&#xD;
      implications to the overall economy and health care systems. A number of risk markers have&#xD;
      been associated with CMDs, including blood serum markers, low levels of lean mass and high&#xD;
      levels of body fat, including increased waist circumference. Dietary factors and nutritional&#xD;
      status have long been linked with specific markers of cardiometabolic (CM) risk. The quantity&#xD;
      and quality of dietary carbohydrates has been associated with increased serum triglycerides&#xD;
      levels, increased body fat mass, increased waist circumference and visceral fat around the&#xD;
      organs in particular. They also seem to increase food cravings. Whilst official dietary&#xD;
      guidelines in the UK and elsewhere still recommend a high carbohydrate and low fat diet as&#xD;
      standard, these recommendations have increasingly been challenged. Evidence has been mounting&#xD;
      that very-low carbohydrate (ketogenic) and low carbohydrate diets can ameliorate CM risk&#xD;
      factors, especially when a personalised rather than a one-size-fits-all approach is being&#xD;
      taken. Response to carbohydrate load and adherence to dietary interventions can vary widely&#xD;
      dependent on individual substrate and energy metabolism and insulin-resistant status.&#xD;
&#xD;
      The majority of dietary interventions with ketogenic and low-carbohydrate diets has focused&#xD;
      on weight loss as the primary outcome in overweight and obese individuals. However, in recent&#xD;
      years evidence has been mounting that the location and quality of adipose tissue (AT) play a&#xD;
      more important role in manifestation of CM risk than quantity of AT alone. Detrimental health&#xD;
      behaviours, such as low-quality diet and low levels of physical activity seem to be important&#xD;
      contributors to this.&#xD;
&#xD;
      Further studies can provide vital insights into the links between diet, location-specific&#xD;
      adipose tissue, CM risk factors and health-related behaviours.&#xD;
&#xD;
      Therefore this 8-weeks randomised pilot study will investigate the impact of either following&#xD;
      a low-carbohydrate, high-fat diet versus following a high-carbohydrates, moderate-fat diet&#xD;
      (UK dietary guidelines) on cardiometabolic risk markers and associated behaviours in a&#xD;
      normal-weight and overweight adult population aged 19 - 64 at potential risk of CMD.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 9, 2017</start_date>
  <completion_date type="Actual">December 8, 2017</completion_date>
  <primary_completion_date type="Actual">December 8, 2017</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <intervention_model_description>Randomised pilot study</intervention_model_description>
    <primary_purpose>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
    <masking_description>Due to the nature of the low-carbohydrate, high-fat and high-carbohydrate, moderate-fat diets masking is not feasible.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Serum lipid profile</measure>
    <time_frame>8 weeks</time_frame>
    <description>Total cholesterol, HDL-C, LDL-C, non-HDL cholesterol, small-dense LDL-C and triglycerides measured in mmol/L</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Blood glucose</measure>
    <time_frame>8 weeks</time_frame>
    <description>Measured in mmol/L</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Systolic and diastolic blood pressure</measure>
    <time_frame>8 weeks</time_frame>
    <description>Measured in mmHg</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Inflammatory markers, such as CRP</measure>
    <time_frame>8 weeks</time_frame>
    <description>Measured in mg/L</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Adiponectin</measure>
    <time_frame>8 weeks</time_frame>
    <description>Measured in μg/mL</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Fibroblast growth factor 21 (FGF21).</measure>
    <time_frame>8 weeks</time_frame>
    <description>Measured in pg/mL</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Tumor necrosis factor alpha and Interleukin 6</measure>
    <time_frame>8 weeks</time_frame>
    <description>Measured in μg/mL</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Body composition - Bioelectrical impedance</measure>
    <time_frame>8 weeks</time_frame>
    <description>Lean mass, fat mass and adipose tissue location and distribution</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Body composition - Anthropometrics</measure>
    <time_frame>8 weeks</time_frame>
    <description>Waist, hip, neck, thigh and calf circumference measured in cm</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Clinical traditional and emerging markers of dietary intake</measure>
    <time_frame>8 weeks</time_frame>
    <description>Fibroblast growth factor 21 and serum metabolites</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Food cravings</measure>
    <time_frame>8 weeks</time_frame>
    <description>Measured via self-reported questionnaire</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Satiety</measure>
    <time_frame>8 weeks</time_frame>
    <description>Assessed via serum leptin levels (ng/mL)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cognition</measure>
    <time_frame>8 weeks</time_frame>
    <description>Assessed via self-reported questionnaire</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Impact on physical activity patterns</measure>
    <time_frame>8 weeks</time_frame>
    <description>Assessed via accelerometry</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Adherence to assigned diet</measure>
    <time_frame>8 weeks</time_frame>
    <description>Measured via 4-day food diaries</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Adherence to dietary guidelines</measure>
    <time_frame>8 weeks</time_frame>
    <description>Measured via diet quality score assessment</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Adherence to low-carbohydrate diet</measure>
    <time_frame>8 weeks</time_frame>
    <description>Measured via blood ketones (mmol/L)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Adherence to fibre recommendations</measure>
    <time_frame>8 weeks</time_frame>
    <description>Measured via structured questionnaires</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Adherence to taking dietary supplement for low-carbohydrate, high-fat group</measure>
    <time_frame>8 weeks</time_frame>
    <description>Measured via counting of number of multi-vitamin and mineral supplements consumed</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Experience with either low-carbohydrate, high-fat or high-carbohydrate, moderate-fat diet</measure>
    <time_frame>8 weeks</time_frame>
    <description>Assessed via semi-structured interview</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">15</enrollment>
  <condition>Cardiometabolic Risk</condition>
  <arm_group>
    <arm_group_label>Low-carbohydrate, high-fat</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants adhering to low-carbohydrate, high-fat diet for 8 weeks.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>High-carbohydrate, moderate fat</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants following high-carbohydrate, moderate-fat diet for 8 weeks.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Low-carbohydrate, high-fat</intervention_name>
    <description>Participants following low-carbohydrate, high-fat diet for 8 weeks.</description>
    <arm_group_label>Low-carbohydrate, high-fat</arm_group_label>
    <other_name>CALIBER LCHF</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>High-carbohydrate, moderate-fat</intervention_name>
    <description>Participants following high-carbohydrate, moderate-fat diet (UK dietary guidelines) for 8 weeks.</description>
    <arm_group_label>High-carbohydrate, moderate fat</arm_group_label>
    <other_name>CALIBER HCMF</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria cohort 1:&#xD;
&#xD;
          1. BMI 18.5 - 29.9kg/m2&#xD;
&#xD;
          2. Aged 19 - 64&#xD;
&#xD;
          3. White-Caucasian&#xD;
&#xD;
          4. Score of ≥4 from a combination of risk markers, including&#xD;
&#xD;
               -  Fasting glucose concentration &gt;5.5mmol/L = 3 points&#xD;
&#xD;
               -  Waist &gt;102cm or 40 inches = 2 points (males)&#xD;
&#xD;
               -  Waist &gt;94 cm or 37 inches = 1 point (males)&#xD;
&#xD;
               -  Waist &gt;88cm or 34inches = 2 points (females)&#xD;
&#xD;
               -  Waist &gt;80 cm or 31 inches = 1 point (females)&#xD;
&#xD;
               -  Systolic blood pressure&gt;130mmHg = 1 point&#xD;
&#xD;
               -  Diastolic BP &gt;85mmHg = 1 point&#xD;
&#xD;
               -  HDL cholesterol concentration &lt;1.0mmol/L = 2 points&#xD;
&#xD;
               -  Serum triglyceride concentration &gt;1.3mmol/L = 1 point.&#xD;
&#xD;
        Exclusion Criteria cohort 1:&#xD;
&#xD;
          1. Smoker&#xD;
&#xD;
          2. Vegetarian or vegan&#xD;
&#xD;
          3. Suffering from food allergies or intolerances&#xD;
&#xD;
          4. Drinking alcohol above recommended UK government guidelines&#xD;
&#xD;
          5. Previous diagnosis of CM disease&#xD;
&#xD;
          6. Taking lipid-lowering medication&#xD;
&#xD;
          7. Taking blood pressure-lowering medication&#xD;
&#xD;
          8. Taking blood glucose-lowering medication&#xD;
&#xD;
          9. Taking dietary supplements&#xD;
&#xD;
         10. Suffering from an eating disorder&#xD;
&#xD;
         11. Current or previous renal impairment&#xD;
&#xD;
        Inclusion Criteria cohort 2:&#xD;
&#xD;
          1. BMI 18.5 - 29.9kg/m2&#xD;
&#xD;
          2. Aged 19 - 64&#xD;
&#xD;
          3. White-Caucasian&#xD;
&#xD;
        Exclusion Criteria cohort 2:&#xD;
&#xD;
          1. Smoker&#xD;
&#xD;
          2. Vegetarian or vegan&#xD;
&#xD;
          3. Suffering from food allergies or intolerances&#xD;
&#xD;
          4. Drinking alcohol above recommended UK government guidelines&#xD;
&#xD;
          5. Previous diagnosis of CM disease&#xD;
&#xD;
          6. Taking lipid-lowering medication&#xD;
&#xD;
          7. Taking blood pressure-lowering medication&#xD;
&#xD;
          8. Taking blood glucose-lowering medication&#xD;
&#xD;
          9. Taking dietary supplements&#xD;
&#xD;
         10. Suffering from an eating disorder&#xD;
&#xD;
         11. Current or previous renal impairment&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>19 Years</minimum_age>
    <maximum_age>64 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Ian G Davies, PhD</last_name>
    <role>Study Chair</role>
    <affiliation>Liverpool John Moores University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Liverpool John Moores University</name>
      <address>
        <city>Liverpool</city>
        <state>Merseyside</state>
        <zip>L17 6BD</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <link>
    <url>http://www.ncbi.nlm.nih.gov/pubmed/12679447</url>
    <description>Brehm, B. et al. (2003) A randomized trial comparing a very low carbohydrate diet and a calorie-restricted low fat diet on body weight and cardiovascular risk factors in healthy women J Clin Endocrinol Metab 88(4), 1617</description>
  </link>
  <link>
    <url>http://www.ncbi.nlm.nih.gov/pubmed/24552752</url>
    <description>Buyken, A., Goletzke, J., Joslowski, G., Felbick, A., Cheng, G., Herder, C. and Brand-Miller, J. (2014) Association between carbohydrate quality and inflammatory markers: systematic review of observational and interventional studies Am J Clin Nutr 99(4),</description>
  </link>
  <link>
    <url>http://www.ncbi.nlm.nih.gov/pubmed/24589564</url>
    <description>De Larochellière, E. et al. (2014) Visceral/epicardial adiposity in nonobese and apparently healthy young adults: association with the cardiometabolic profile Ath</description>
  </link>
  <link>
    <url>http://www.ncbi.nlm.nih.gov/pubmed/26024544</url>
    <description>Fischer, K., Pick, J., Moewes, D. and Nöthlings, U. (2015) Qualitative aspects of diet affecting visceral and subcutaneous abdominal adipose tissue: a systematic review of observational and controlled intervention studies Nutr Rev 73(4), 191-215</description>
  </link>
  <link>
    <url>http://www.ncbi.nlm.nih.gov/pubmed/23223345</url>
    <description>Gadgil, M., Appel, L., Yeung, E., Anderson, C., Sacks, F. and Miller, E. (2013) The effects of carbohydrate, unsaturated fat, and protein intake on measures of insulin sensitivity: results from the OmniHeart trial Diabetes Care 36 (5), 1132-1137</description>
  </link>
  <link>
    <url>http://www.ncbi.nlm.nih.gov/pubmed/25089189</url>
    <description>Gardner, C. (2012) Tailoring dietary approaches for weight loss Int J Obes Suppl 2(Suppl 1), S11-S15</description>
  </link>
  <link>
    <url>http://www.ncbi.nlm.nih.gov/pubmed/26393645</url>
    <description>Hu, T. and Bazzano, L. (2014) The low-carbohydrate diet and cardiovascular risk factors: evidence from epidemiologic studies Nutr Metab Cardiovasc Dis 24(4), 337-343</description>
  </link>
  <link>
    <url>http://www.ncbi.nlm.nih.gov/pubmed/27114827</url>
    <description>Hu, T., Yao, L., Reynolds, K., Niu, T., Li, S., Whelton, P., He, J., Steffen, L. and Bazzano, L. (2016) Adherence to low-carbohydrate and low-fat diets in relation to weight loss and cardiovascular risk factors Obes Sci Pract, 2(1), 24-3</description>
  </link>
  <link>
    <url>http://www.ncbi.nlm.nih.gov/pubmed/25912185</url>
    <description>Ko, B., Park, K., Shin, S., Zaichenko, L., Davis, C., Crowell, J., Joung, H. and Mantzoros, C (2016) Diet quality and diet patterns in relation to circulating cardiometabolic biomarkers Clin Nutr. 35(2), 484-90</description>
  </link>
  <link>
    <url>http://www.ncbi.nlm.nih.gov/pubmed/23068073</url>
    <description>Lee, M., Wu, Y. and Fried, S. (2013) Adipose tissue heterogeneity: implication of depot differences in adipose tissue for obesity complications Mol Aspects Med 34 (1), 1-11</description>
  </link>
  <link>
    <url>http://www.ncbi.nlm.nih.gov/pubmed/23803881</url>
    <description>Lennerz, B., Alsop, D., Holsen, L., Stern, E., Rojas, R., Ebbeling, C., Goldstein, J.and Ludwig, D. (2013) Effects of dietary glycemic index on brain regions related to reward and craving in men Am J Clin Nutr 98(3), 641-647</description>
  </link>
  <link>
    <url>http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4924165/</url>
    <description>Allam-Ndoul, B., Guénard, F., Garneau, V., Cormier, H., Barbier, O., Pérusse, L., et al. (2016) Association between Metabolite Profiles, Metabolic Syndrome and Obesity Status. Nutrients 8(6)</description>
  </link>
  <link>
    <url>http://www.ncbi.nlm.nih.gov/pubmed/22539584</url>
    <description>Lin, Z., Gong, Q., Wu, C., Yu, J., Lu, T., Pan, X., Lin, S. and Li, X. (2012) 'Dynamic change of serum FGF21 levels in response to glucose challenge in human J Clin Endocrinol Metab, 97(7), E1224-1228.</description>
  </link>
  <verification_date>March 2018</verification_date>
  <study_first_submitted>August 14, 2017</study_first_submitted>
  <study_first_submitted_qc>August 17, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 22, 2017</study_first_posted>
  <last_update_submitted>March 7, 2018</last_update_submitted>
  <last_update_submitted_qc>March 7, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">March 8, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Liverpool John Moores University</investigator_affiliation>
    <investigator_full_name>Tanja Harrison</investigator_full_name>
    <investigator_title>PhD Researcher and Registered Associate Nutritionist</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Overweight</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03257085
org study id: CALIBER
nct id: NCT03257085
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Pilot study to compare the impact of following a low-carbohydrate, high-fat diet versus
      following a high-carbohydrates, moderate-fat diet (UK dietary guidelines) on cardiometabolic
      risk markers and associated behaviours in a normal-weight and overweight adult population.
Cardiometabolic diseases (CMD), such as type 2 diabetes and cardiovascular disease (CVD), are
      globally amongst the highest contributors to morbidity and mortality with high (cost)
      implications to the overall economy and health care systems. A number of risk markers have
      been associated with CMDs, including blood serum markers, low levels of lean mass and high
      levels of body fat, including increased waist circumference. Dietary factors and nutritional
      status have long been linked with specific markers of cardiometabolic (CM) risk. The quantity
      and quality of dietary carbohydrates has been associated with increased serum triglycerides
      levels, increased body fat mass, increased waist circumference and visceral fat around the
      organs in particular. They also seem to increase food cravings. Whilst official dietary
      guidelines in the UK and elsewhere still recommend a high carbohydrate and low fat diet as
      standard, these recommendations have increasingly been challenged. Evidence has been mounting
      that very-low carbohydrate (ketogenic) and low carbohydrate diets can ameliorate CM risk
      factors, especially when a personalised rather than a one-size-fits-all approach is being
      taken. Response to carbohydrate load and adherence to dietary interventions can vary widely
      dependent on individual substrate and energy metabolism and insulin-resistant status.

      The majority of dietary interventions with ketogenic and low-carbohydrate diets has focused
      on weight loss as the primary outcome in overweight and obese individuals. However, in recent
      years evidence has been mounting that the location and quality of adipose tissue (AT) play a
      more important role in manifestation of CM risk than quantity of AT alone. Detrimental health
      behaviours, such as low-quality diet and low levels of physical activity seem to be important
      contributors to this.

      Further studies can provide vital insights into the links between diet, location-specific
      adipose tissue, CM risk factors and health-related behaviours.

      Therefore this 8-weeks randomised pilot study will investigate the impact of either following
      a low-carbohydrate, high-fat diet versus following a high-carbohydrates, moderate-fat diet
      (UK dietary guidelines) on cardiometabolic risk markers and associated behaviours in a
      normal-weight and overweight adult population aged 19 - 64 at potential risk of CMD.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Randomised pilot study
primary purpose: Prevention
masking: None (Open Label)
masking description: Due to the nature of the low-carbohydrate, high-fat and high-carbohydrate, moderate-fat diets masking is not feasible.
measure: Serum lipid profile
time frame: 8 weeks
description: Total cholesterol, HDL-C, LDL-C, non-HDL cholesterol, small-dense LDL-C and triglycerides measured in mmol/L
measure: Blood glucose
time frame: 8 weeks
description: Measured in mmol/L
measure: Systolic and diastolic blood pressure
time frame: 8 weeks
description: Measured in mmHg
measure: Inflammatory markers, such as CRP
time frame: 8 weeks
description: Measured in mg/L
measure: Adiponectin
time frame: 8 weeks
description: Measured in μg/mL
measure: Fibroblast growth factor 21 (FGF21).
time frame: 8 weeks
description: Measured in pg/mL
measure: Tumor necrosis factor alpha and Interleukin 6
time frame: 8 weeks
description: Measured in μg/mL
measure: Body composition - Bioelectrical impedance
time frame: 8 weeks
description: Lean mass, fat mass and adipose tissue location and distribution
measure: Body composition - Anthropometrics
time frame: 8 weeks
description: Waist, hip, neck, thigh and calf circumference measured in cm
measure: Clinical traditional and emerging markers of dietary intake
time frame: 8 weeks
description: Fibroblast growth factor 21 and serum metabolites
measure: Food cravings
time frame: 8 weeks
description: Measured via self-reported questionnaire
measure: Satiety
time frame: 8 weeks
description: Assessed via serum leptin levels (ng/mL)
measure: Cognition
time frame: 8 weeks
description: Assessed via self-reported questionnaire
measure: Impact on physical activity patterns
time frame: 8 weeks
description: Assessed via accelerometry
measure: Adherence to assigned diet
time frame: 8 weeks
description: Measured via 4-day food diaries
measure: Adherence to dietary guidelines
time frame: 8 weeks
description: Measured via diet quality score assessment
measure: Adherence to low-carbohydrate diet
time frame: 8 weeks
description: Measured via blood ketones (mmol/L)
measure: Adherence to fibre recommendations
time frame: 8 weeks
description: Measured via structured questionnaires
measure: Adherence to taking dietary supplement for low-carbohydrate, high-fat group
time frame: 8 weeks
description: Measured via counting of number of multi-vitamin and mineral supplements consumed
measure: Experience with either low-carbohydrate, high-fat or high-carbohydrate, moderate-fat diet
time frame: 8 weeks
description: Assessed via semi-structured interview
arm group label: Low-carbohydrate, high-fat
arm group type: Experimental
description: Participants adhering to low-carbohydrate, high-fat diet for 8 weeks.
arm group label: High-carbohydrate, moderate fat
arm group type: Experimental
description: Participants following high-carbohydrate, moderate-fat diet for 8 weeks.
intervention type: Other
intervention name: Low-carbohydrate, high-fat
description: Participants following low-carbohydrate, high-fat diet for 8 weeks.
arm group label: Low-carbohydrate, high-fat
other name: CALIBER LCHF
intervention type: Other
intervention name: High-carbohydrate, moderate-fat
description: Participants following high-carbohydrate, moderate-fat diet (UK dietary guidelines) for 8 weeks.
arm group label: High-carbohydrate, moderate fat
other name: CALIBER HCMF
criteria: 
gender: All
minimum age: 19 Years
maximum age: 64 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Ian G Davies, PhD
role: Study Chair
affiliation: Liverpool John Moores University
facility: 
country: United Kingdom
url: http://www.ncbi.nlm.nih.gov/pubmed/12679447
description: Brehm, B. et al. (2003) A randomized trial comparing a very low carbohydrate diet and a calorie-restricted low fat diet on body weight and cardiovascular risk factors in healthy women J Clin Endocrinol Metab 88(4), 1617
url: http://www.ncbi.nlm.nih.gov/pubmed/24552752
description: Buyken, A., Goletzke, J., Joslowski, G., Felbick, A., Cheng, G., Herder, C. and Brand-Miller, J. (2014) Association between carbohydrate quality and inflammatory markers: systematic review of observational and interventional studies Am J Clin Nutr 99(4),
url: http://www.ncbi.nlm.nih.gov/pubmed/24589564
description: De Larochellière, E. et al. (2014) Visceral/epicardial adiposity in nonobese and apparently healthy young adults: association with the cardiometabolic profile Ath
url: http://www.ncbi.nlm.nih.gov/pubmed/26024544
description: Fischer, K., Pick, J., Moewes, D. and Nöthlings, U. (2015) Qualitative aspects of diet affecting visceral and subcutaneous abdominal adipose tissue: a systematic review of observational and controlled intervention studies Nutr Rev 73(4), 191-215
url: http://www.ncbi.nlm.nih.gov/pubmed/23223345
description: Gadgil, M., Appel, L., Yeung, E., Anderson, C., Sacks, F. and Miller, E. (2013) The effects of carbohydrate, unsaturated fat, and protein intake on measures of insulin sensitivity: results from the OmniHeart trial Diabetes Care 36 (5), 1132-1137
url: http://www.ncbi.nlm.nih.gov/pubmed/25089189
description: Gardner, C. (2012) Tailoring dietary approaches for weight loss Int J Obes Suppl 2(Suppl 1), S11-S15
url: http://www.ncbi.nlm.nih.gov/pubmed/26393645
description: Hu, T. and Bazzano, L. (2014) The low-carbohydrate diet and cardiovascular risk factors: evidence from epidemiologic studies Nutr Metab Cardiovasc Dis 24(4), 337-343
url: http://www.ncbi.nlm.nih.gov/pubmed/27114827
description: Hu, T., Yao, L., Reynolds, K., Niu, T., Li, S., Whelton, P., He, J., Steffen, L. and Bazzano, L. (2016) Adherence to low-carbohydrate and low-fat diets in relation to weight loss and cardiovascular risk factors Obes Sci Pract, 2(1), 24-3
url: http://www.ncbi.nlm.nih.gov/pubmed/25912185
description: Ko, B., Park, K., Shin, S., Zaichenko, L., Davis, C., Crowell, J., Joung, H. and Mantzoros, C (2016) Diet quality and diet patterns in relation to circulating cardiometabolic biomarkers Clin Nutr. 35(2), 484-90
url: http://www.ncbi.nlm.nih.gov/pubmed/23068073
description: Lee, M., Wu, Y. and Fried, S. (2013) Adipose tissue heterogeneity: implication of depot differences in adipose tissue for obesity complications Mol Aspects Med 34 (1), 1-11
url: http://www.ncbi.nlm.nih.gov/pubmed/23803881
description: Lennerz, B., Alsop, D., Holsen, L., Stern, E., Rojas, R., Ebbeling, C., Goldstein, J.and Ludwig, D. (2013) Effects of dietary glycemic index on brain regions related to reward and craving in men Am J Clin Nutr 98(3), 641-647
url: http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4924165/
description: Allam-Ndoul, B., Guénard, F., Garneau, V., Cormier, H., Barbier, O., Pérusse, L., et al. (2016) Association between Metabolite Profiles, Metabolic Syndrome and Obesity Status. Nutrients 8(6)
url: http://www.ncbi.nlm.nih.gov/pubmed/22539584
description: Lin, Z., Gong, Q., Wu, C., Yu, J., Lu, T., Pan, X., Lin, S. and Li, X. (2012) 'Dynamic change of serum FGF21 levels in response to glucose challenge in human J Clin Endocrinol Metab, 97(7), E1224-1228.
responsible party type: Principal Investigator
investigator affiliation: Liverpool John Moores University
investigator full name: Tanja Harrison
investigator title: PhD Researcher and Registered Associate Nutritionist
mesh term: Overweight
sharing ipd: Undecided