<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/NCT04415632</url>
  </required_header>
  <id_info>
    <org_study_id>19042</org_study_id>
    <secondary_id>262245</secondary_id>
    <secondary_id>19/EM/0291</secondary_id>
    <nct_id>NCT04415632</nct_id>
  </id_info>
  <brief_title>Low GI Diet Effects on Non-Alcoholic Fatty Liver Disease</brief_title>
  <acronym>LGI-NAFLD</acronym>
  <official_title>Effects of an Iso-energetic Low Glycemic Index (GI) Diet on Liver Fat Accumulation and Gut Microbiota Composition in Patients With Non- Alcoholic Fatty Liver Disease (NAFLD)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Nottingham</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Nottingham</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      A 2 x 2 cross-over dietary intervention trial designed to investigate the effects of low&#xD;
      glycemic index (LGI) versus high glycemic index (HGI) diet on hepatic fat accumulation and&#xD;
      gut microbiota composition in participants with NAFLD.&#xD;
&#xD;
      Participants will be allocated randomly to a 2-week either high GI (HGI) or low GI (LGI) diet&#xD;
      followed by a 4-week wash-out period and then the LGI or HGI diet, opposite to the first&#xD;
      2-weeks (N= 16).&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">December 10, 2020</start_date>
  <completion_date type="Anticipated">October 2023</completion_date>
  <primary_completion_date type="Anticipated">October 2022</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>Crossover Assignment</intervention_model>
    <primary_purpose>Other</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>liver fat content</measure>
    <time_frame>At baseline</time_frame>
    <description>To assess the difference in liver fat content between LGI and HGI diet groups in participants with NAFLD using MRI/S</description>
  </primary_outcome>
  <primary_outcome>
    <measure>liver fat content</measure>
    <time_frame>2 weeks</time_frame>
    <description>To assess the difference in liver fat content between LGI and HGI diet groups in participants with NAFLD using MRI/S</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Gut microbial composition</measure>
    <time_frame>At baseline</time_frame>
    <description>To assess the difference in gut microbiota composition between LGI and HGI diet groups in participants with NAFLD using 16S sequencing of rRNA</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Gut microbial composition</measure>
    <time_frame>2 weeks</time_frame>
    <description>To assess the difference in gut microbiota composition between LGI and HGI diet groups in participants with NAFLD using 16S sequencing of rRNA</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Blood glucose level</measure>
    <time_frame>At baseline</time_frame>
    <description>To assess the differences in blood glucose levels between LGI and HGI diet groups in participants with NAFLD using Horiba automated analyser.&#xD;
.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Blood glucose level</measure>
    <time_frame>2 weeks</time_frame>
    <description>To assess the differences in blood glucose levels between LGI and HGI diet groups in participants with NAFLD using Horiba automated analyser.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Blood insulin levels</measure>
    <time_frame>At baseline</time_frame>
    <description>To assess the differences in blood insulin levels between LGI and HGI diet groups in participants with NAFLD using radioimmunoassay methods .</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Blood insulin levels</measure>
    <time_frame>2 weeks</time_frame>
    <description>To assess the differences in blood insulin levels between LGI and HGI diet groups in participants with NAFLD using radioimmunoassay methods .</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>blood liver function tests</measure>
    <time_frame>At baseline</time_frame>
    <description>To assess the differences in liver function biomarkers between LGI and HGI diet groups in participants with NAFLD using Horiba automated analyser. The blood liver function tests (LFTs) to be assessed are GGT(Gamma-Glutamyl Transferase), ALP(Alkaline Phosphatase), AST(Aspartate Amino Transferase), and ALT(Alanine Amino Transferase)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>blood liver function test</measure>
    <time_frame>2 weeks</time_frame>
    <description>To assess the differences in liver function biomarkers between LGI and HGI diet groups in participants with NAFLD using Horiba automated analyser. The blood liver function tests (LFTs) to be assessed are GGT(Gamma-Glutamyl Transferase), ALP(Alkaline Phosphatase), AST(Aspartate Amino Transferase), and ALT(Alanine Amino Transferase)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>blood lipids levels</measure>
    <time_frame>At baseline</time_frame>
    <description>To assess the differences in blood lipids levels between LGI and HGI diet groups in participants with NAFLD using Horiba automated analyser. The blood lipids biomarkers to be assessed are Total Cholesterol, Free Fatty Acids, High-density lipoprotein, low-density lipoprotein, Triglycerides.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>blood lipids levels</measure>
    <time_frame>2 weeks</time_frame>
    <description>To assess the differences in blood lipids levels between LGI and HGI diet groups in participants with NAFLD using Horiba automated analyser. The blood lipids biomarkers to be assessed are Total Cholesterol, Free Fatty Acids, High-density lipoprotein, low-density lipoprotein, Triglycerides.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>blood gut hormones levels</measure>
    <time_frame>At baseline</time_frame>
    <description>To assess the differences in blood gut hormones levels between LGI and HGI diet groups in participants with NAFLD using radioimmunoassay (RIA) or Sandwich ELISA methods. The blood gut hormones to be assessed are Glucagon, Leptin, Ghrelin, PYY (Peptide YY), GLP-1 (Glucagon-like peptide 1).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>blood gut hormones levels</measure>
    <time_frame>2 weeks</time_frame>
    <description>To assess the differences in blood gut hormones levels between LGI and HGI diet groups in participants with NAFLD using radioimmunoassay (RIA) or Sandwich ELISA methods. The blood gut hormones to be assessed are Glucagon, Leptin, Ghrelin, PYY (Peptide YY), GLP-1 (Glucagon-like peptide 1).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Plasma Short Chain Fatty Acids (SCFAs)</measure>
    <time_frame>At baseline</time_frame>
    <description>To investigate the differences in plasma SCFAs between LGI and HGI diet groups in participants with NAFLD.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Plasma Short Chain Fatty Acids (SCFAs)</measure>
    <time_frame>2 weeks</time_frame>
    <description>To investigate the differences in plasma SCFAs between LGI and HGI diet groups in participants with NAFLD.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Anthropometric measurements</measure>
    <time_frame>At baseline</time_frame>
    <description>Weight in kg, Height in meters will be combined to report BMI kg/m^2 or each study arm</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Anthropometric measurements</measure>
    <time_frame>2 weeks</time_frame>
    <description>Weight in kg, Height in meters will be combined to report BMI kg/m^2 or each study arm</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Body composition Fat Mass</measure>
    <time_frame>At baseline</time_frame>
    <description>Bio-electrical Impedance analysis (BIA) will be used to assess the body composition of fat mass %.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Body composition Fat Mass</measure>
    <time_frame>2 weeks</time_frame>
    <description>Bio-electrical Impedance analysis (BIA) will be used to assess the body composition of fat mass %.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Body composition Muscle Mass</measure>
    <time_frame>At baseline</time_frame>
    <description>Bio-electrical Impedance analysis (BIA) will be used to assess the body composition of muscle mass %.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Body composition Muscle Mass</measure>
    <time_frame>2 weeks</time_frame>
    <description>Bio-electrical Impedance analysis (BIA) will be used to assess the body composition of muscle mass %.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Body composition Water Content</measure>
    <time_frame>At baseline</time_frame>
    <description>Bio-electrical Impedance analysis (BIA) will be used to assess the body composition of water content %.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Body composition Water Content</measure>
    <time_frame>2 weeks</time_frame>
    <description>Bio-electrical Impedance analysis (BIA) will be used to assess the body composition of water content %.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Visual analogue scales (VAS)</measure>
    <time_frame>through study completion, an average of two weeks</time_frame>
    <description>Visual analogue scales (VAS) in 0 to 10 cm scale will be used to assess the participant's subjective appetite (hunger and fullness) during the each study arm.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">16</enrollment>
  <condition>Fatty Liver</condition>
  <condition>Nutritional and Metabolic Disease</condition>
  <arm_group>
    <arm_group_label>LGI Diet</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>low glycemic index diet</description>
  </arm_group>
  <arm_group>
    <arm_group_label>HGI Diet</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>High glycemic index diet</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>low glycemic index diet</intervention_name>
    <description>• Three-day cycle menu of LGI diet will be designed and supplied to each participant in an amount designed to meet their estimated energy requirements. The percentage energy from protein, fat and carbohydrate will be the same in the two diets. Each diet period of the trial will last for two weeks.</description>
    <arm_group_label>LGI Diet</arm_group_label>
    <other_name>LGI</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>High glycemic index diet</intervention_name>
    <description>Three-day cycle menu of HGI diet will be designed and supplied to each participant in an amount designed to meet their estimated energy requirements. The percentage energy from protein, fat and carbohydrate will be the same in the two diets. Each diet period of the trial will last for two weeks.</description>
    <arm_group_label>HGI Diet</arm_group_label>
    <other_name>HGI</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  • Adult males and females aged from 18 to 65 years (balanced number).&#xD;
&#xD;
               -  Detected NAFLD by CAP-FibroScan™ &gt;288dB/m or by MRI-PDFF) &gt; 5% fat of liver&#xD;
                  weight.&#xD;
&#xD;
               -  Body mass index ≥ 25 kg/m2&#xD;
&#xD;
               -  Have current moderate to high GI diet intake of ≥ 60 (Assessed from a completed&#xD;
                  7-day food diary).&#xD;
&#xD;
               -  Abdominal obesity (Waist circumference &gt; 102 cm for males and &gt; 88 cm for&#xD;
                  females)&#xD;
&#xD;
               -  Able to give informed consent.&#xD;
&#xD;
               -  Able to undergo MRI/S and CAP-FibroScan™.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  • Current smokers and excessive alcohol drinkers (&gt; 14 units/week).&#xD;
&#xD;
               -  Perimenopausal (irregular periods) women.&#xD;
&#xD;
               -  Participants with other liver abnormalities.&#xD;
&#xD;
               -  Participants with history of gastrointestinal surgeries, depression, eating&#xD;
                  disorders or difficulties.&#xD;
&#xD;
               -  Participants using pharmacologic agents for obesity or NAFLD.&#xD;
&#xD;
               -  Participants with type 1 diabetes.&#xD;
&#xD;
               -  Participants with type 2 diabetes on second line medications (eg GLP-1 analogues,&#xD;
                  sulfonylureas).&#xD;
&#xD;
               -  Participation in any other trial in the last 3 months.&#xD;
&#xD;
               -  Participants on any special diets (e.g. vegetarians).&#xD;
&#xD;
               -  Intolerance to foods included in the diet plan.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>NIHR Nottingham Clinical Research Facility Nottingham Digestive Diseases Centre</name>
      <address>
        <city>Nottingham</city>
        <state>Nottinghamshire</state>
        <zip>NG7 2UH</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Amina Al-Awadi</last_name>
      <phone>+44 (0)115 823 1073</phone>
      <email>Amina.Alawadi@nuh.nhs.uk</email>
    </contact>
    <investigator>
      <last_name>Guruprasad Aithal, Professor</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <verification_date>September 2021</verification_date>
  <study_first_submitted>April 20, 2020</study_first_submitted>
  <study_first_submitted_qc>May 29, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 4, 2020</study_first_posted>
  <last_update_submitted>September 28, 2021</last_update_submitted>
  <last_update_submitted_qc>September 28, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">September 29, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Liver Diseases</mesh_term>
    <mesh_term>Fatty Liver</mesh_term>
    <mesh_term>Non-alcoholic Fatty Liver Disease</mesh_term>
    <mesh_term>Metabolic Diseases</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>Within a five-year timeframe, the final anonymized trial data will be uploaded to the https://rdmc.nottingham.ac.uk public repository after consistency and quality have been verified by the project team and publication of the results. Data from this trial are intended to be presented at local and international conferences including those attended by clinicians and dietitians and will also be used as part of a Philosophy Doctorate thesis. Publications will be in peer reviewed journals. No participant will be identified in any of these publications.</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
    <ipd_info_type>Informed Consent Form (ICF)</ipd_info_type>
    <ipd_time_frame>within five years time-frame</ipd_time_frame>
    <ipd_access_criteria>Public repository. presented at local and international conferences. part of a Philosophy Doctorate thesis</ipd_access_criteria>
    <ipd_url>https://rdmc.nottingham.ac.uk</ipd_url>
  </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/NCT04415632
org study id: 19042
secondary id: 262245
secondary id: 19/EM/0291
nct id: NCT04415632
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
A 2 x 2 cross-over dietary intervention trial designed to investigate the effects of low
      glycemic index (LGI) versus high glycemic index (HGI) diet on hepatic fat accumulation and
      gut microbiota composition in participants with NAFLD.

      Participants will be allocated randomly to a 2-week either high GI (HGI) or low GI (LGI) diet
      followed by a 4-week wash-out period and then the LGI or HGI diet, opposite to the first
      2-weeks (N= 16).
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Other
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: liver fat content
time frame: At baseline
description: To assess the difference in liver fat content between LGI and HGI diet groups in participants with NAFLD using MRI/S
measure: liver fat content
time frame: 2 weeks
description: To assess the difference in liver fat content between LGI and HGI diet groups in participants with NAFLD using MRI/S
measure: Gut microbial composition
time frame: At baseline
description: To assess the difference in gut microbiota composition between LGI and HGI diet groups in participants with NAFLD using 16S sequencing of rRNA
measure: Gut microbial composition
time frame: 2 weeks
description: To assess the difference in gut microbiota composition between LGI and HGI diet groups in participants with NAFLD using 16S sequencing of rRNA
measure: Blood glucose level
time frame: At baseline
description: To assess the differences in blood glucose levels between LGI and HGI diet groups in participants with NAFLD using Horiba automated analyser.
.
measure: Blood glucose level
time frame: 2 weeks
description: To assess the differences in blood glucose levels between LGI and HGI diet groups in participants with NAFLD using Horiba automated analyser.
measure: Blood insulin levels
time frame: At baseline
description: To assess the differences in blood insulin levels between LGI and HGI diet groups in participants with NAFLD using radioimmunoassay methods .
measure: Blood insulin levels
time frame: 2 weeks
description: To assess the differences in blood insulin levels between LGI and HGI diet groups in participants with NAFLD using radioimmunoassay methods .
measure: blood liver function tests
time frame: At baseline
description: To assess the differences in liver function biomarkers between LGI and HGI diet groups in participants with NAFLD using Horiba automated analyser. The blood liver function tests (LFTs) to be assessed are GGT(Gamma-Glutamyl Transferase), ALP(Alkaline Phosphatase), AST(Aspartate Amino Transferase), and ALT(Alanine Amino Transferase)
measure: blood liver function test
time frame: 2 weeks
description: To assess the differences in liver function biomarkers between LGI and HGI diet groups in participants with NAFLD using Horiba automated analyser. The blood liver function tests (LFTs) to be assessed are GGT(Gamma-Glutamyl Transferase), ALP(Alkaline Phosphatase), AST(Aspartate Amino Transferase), and ALT(Alanine Amino Transferase)
measure: blood lipids levels
time frame: At baseline
description: To assess the differences in blood lipids levels between LGI and HGI diet groups in participants with NAFLD using Horiba automated analyser. The blood lipids biomarkers to be assessed are Total Cholesterol, Free Fatty Acids, High-density lipoprotein, low-density lipoprotein, Triglycerides.
measure: blood lipids levels
time frame: 2 weeks
description: To assess the differences in blood lipids levels between LGI and HGI diet groups in participants with NAFLD using Horiba automated analyser. The blood lipids biomarkers to be assessed are Total Cholesterol, Free Fatty Acids, High-density lipoprotein, low-density lipoprotein, Triglycerides.
measure: blood gut hormones levels
time frame: At baseline
description: To assess the differences in blood gut hormones levels between LGI and HGI diet groups in participants with NAFLD using radioimmunoassay (RIA) or Sandwich ELISA methods. The blood gut hormones to be assessed are Glucagon, Leptin, Ghrelin, PYY (Peptide YY), GLP-1 (Glucagon-like peptide 1).
measure: blood gut hormones levels
time frame: 2 weeks
description: To assess the differences in blood gut hormones levels between LGI and HGI diet groups in participants with NAFLD using radioimmunoassay (RIA) or Sandwich ELISA methods. The blood gut hormones to be assessed are Glucagon, Leptin, Ghrelin, PYY (Peptide YY), GLP-1 (Glucagon-like peptide 1).
measure: Plasma Short Chain Fatty Acids (SCFAs)
time frame: At baseline
description: To investigate the differences in plasma SCFAs between LGI and HGI diet groups in participants with NAFLD.
measure: Plasma Short Chain Fatty Acids (SCFAs)
time frame: 2 weeks
description: To investigate the differences in plasma SCFAs between LGI and HGI diet groups in participants with NAFLD.
measure: Anthropometric measurements
time frame: At baseline
description: Weight in kg, Height in meters will be combined to report BMI kg/m^2 or each study arm
measure: Anthropometric measurements
time frame: 2 weeks
description: Weight in kg, Height in meters will be combined to report BMI kg/m^2 or each study arm
measure: Body composition Fat Mass
time frame: At baseline
description: Bio-electrical Impedance analysis (BIA) will be used to assess the body composition of fat mass %.
measure: Body composition Fat Mass
time frame: 2 weeks
description: Bio-electrical Impedance analysis (BIA) will be used to assess the body composition of fat mass %.
measure: Body composition Muscle Mass
time frame: At baseline
description: Bio-electrical Impedance analysis (BIA) will be used to assess the body composition of muscle mass %.
measure: Body composition Muscle Mass
time frame: 2 weeks
description: Bio-electrical Impedance analysis (BIA) will be used to assess the body composition of muscle mass %.
measure: Body composition Water Content
time frame: At baseline
description: Bio-electrical Impedance analysis (BIA) will be used to assess the body composition of water content %.
measure: Body composition Water Content
time frame: 2 weeks
description: Bio-electrical Impedance analysis (BIA) will be used to assess the body composition of water content %.
measure: Visual analogue scales (VAS)
time frame: through study completion, an average of two weeks
description: Visual analogue scales (VAS) in 0 to 10 cm scale will be used to assess the participant's subjective appetite (hunger and fullness) during the each study arm.
arm group label: LGI Diet
arm group type: Experimental
description: low glycemic index diet
arm group label: HGI Diet
arm group type: Other
description: High glycemic index diet
intervention type: Other
intervention name: low glycemic index diet
description: • Three-day cycle menu of LGI diet will be designed and supplied to each participant in an amount designed to meet their estimated energy requirements. The percentage energy from protein, fat and carbohydrate will be the same in the two diets. Each diet period of the trial will last for two weeks.
arm group label: LGI Diet
other name: LGI
intervention type: Other
intervention name: High glycemic index diet
description: Three-day cycle menu of HGI diet will be designed and supplied to each participant in an amount designed to meet their estimated energy requirements. The percentage energy from protein, fat and carbohydrate will be the same in the two diets. Each diet period of the trial will last for two weeks.
arm group label: HGI Diet
other name: HGI
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
facility: 
status: Recruiting
contact: 
investigator: 
country: United Kingdom
responsible party type: Sponsor
mesh term: Liver Diseases
mesh term: Fatty Liver
mesh term: Non-alcoholic Fatty Liver Disease
mesh term: Metabolic Diseases
sharing ipd: Yes
ipd description: Within a five-year timeframe, the final anonymized trial data will be uploaded to the https://rdmc.nottingham.ac.uk public repository after consistency and quality have been verified by the project team and publication of the results. Data from this trial are intended to be presented at local and international conferences including those attended by clinicians and dietitians and will also be used as part of a Philosophy Doctorate thesis. Publications will be in peer reviewed journals. No participant will be identified in any of these publications.
ipd info type: Study Protocol
ipd info type: Statistical Analysis Plan (SAP)
ipd info type: Informed Consent Form (ICF)
ipd time frame: within five years time-frame
ipd access criteria: Public repository. presented at local and international conferences. part of a Philosophy Doctorate thesis
ipd url: https://rdmc.nottingham.ac.uk