<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/NCT03805776</url>
  </required_header>
  <id_info>
    <org_study_id>123</org_study_id>
    <nct_id>NCT03805776</nct_id>
  </id_info>
  <brief_title>Intermittent Fasting in Dyslipidemia</brief_title>
  <official_title>Role of Intermittent Fasting in Improving High Density Lipoprotein Cholesterol</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Aga Khan University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Aga Khan 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>
      World Health Organization report notifies of the escalating global burden of cardiovascular&#xD;
      diseases (CVD), projecting that it will become the major worldwide cause of death and&#xD;
      disability by 2020. The South Asian countries have the highest rates of CVD globally. It is&#xD;
      widely acknowledged that South Asians have 40-60% higher risk of CVD linked to mortality,&#xD;
      compared with other populations. Multiple human population studies have established the&#xD;
      concentration of high density lipoprotein (HDL) cholesterol as an independent, inverse&#xD;
      predictor of the risk of having a cardiovascular event. Furthermore, HDLs have several&#xD;
      well-documented functions with the potential to protect against cardiovascular disease. This&#xD;
      study trial is designed to find out the role of intermittent fasting to improve the&#xD;
      dyslipidemia and particularly increase the levels of HDL in general population. Investigators&#xD;
      expect that the intermittent fasting will significantly enhance the level of HDL and reduce&#xD;
      cardiovascular events in general population.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      INTRODUCTION:&#xD;
&#xD;
      Overall lipid profile is important in cardiovascular diseases but particularly serum HDL&#xD;
      levels have long been recognized as an independent inverse prognostic marker of CVD, when the&#xD;
      Framigham study, in 1980s showed that HDL below 40-60mg/dl is of prognostic relevance. A rise&#xD;
      of 1mg/dl in HDL levels is considered to reduce coronary artery disease (CAD) risk to 2-3%.&#xD;
      Even patients with elevated total cholesterol (TC) and LDL, presenting a high HDL are seen to&#xD;
      be protected from atherosclerosis. Multiple human population studies have shown the&#xD;
      concentration of HDL cholesterol as an independent, inverse predictor of the risk of having a&#xD;
      cardiovascular event. Additionally, HDL has several well-documented functions with the&#xD;
      potential to protect against cardiovascular diseases. These include an ability to promote the&#xD;
      efflux of cholesterol from macrophages in the artery wall, inhibit the oxidative modification&#xD;
      of LDL, inhibit vascular inflammation, inhibit thrombosis, promote endothelial repair,&#xD;
      promote angiogenesis, anti-oxidant, enhance endothelial function, improve diabetic control,&#xD;
      and inhibit hematopoietic stem cell proliferation. HDL also exerts direct cardio protective&#xD;
      effect, which are mediated with its interactions with the myocardium.&#xD;
&#xD;
      Various studies have emphasised the high incidence of CVD within the South Asian countries.&#xD;
      The increased risk of cardiovascular events in South Asians at a younger age might be due to&#xD;
      unknown factors affecting plaque rupture, the interaction between prothrombotic factors and&#xD;
      atherosclerosis, or may be due to any undiscovered risk factors. Urbanisation and&#xD;
      westernisation is characterised by a distinct increase in the intake of energy dense foods, a&#xD;
      decrease in physical activity, and a heightened level of psychosocial stress, all of which&#xD;
      promote the development of hyperglycaemia, hypertension, and dyslipidaemia. Most common&#xD;
      dyslipidaemia in South Asians is low HDL-C and high triglycerides. High triglyceride and low&#xD;
      HDL-C levels are metabolically interlinked. This metabolic phenotype is also associated with&#xD;
      increased levels of small LDL particles despite relatively normal levels of LDL-C among South&#xD;
      Asians. This clinical syndrome is accompanied by insulin resistance, a condition frequently&#xD;
      referred to as atherogenic dyslipidemia, which is a common metabolic derangement among Asian.&#xD;
      South Asians not only have lower HDL levels but also have a higher concentration of small,&#xD;
      less-protective HDL particles. One proposed mechanism is presence of dysfunctional HDL&#xD;
      particles. Another potential explanation for the apparent blunted cardioprotection of HDL in&#xD;
      South Asians might be related to HDL particle size. Small particles might be less efficient&#xD;
      in reverse cholesterol transport. In general, HDL particle size tends to be lower in patients&#xD;
      with CHD and those with low HDL-C levels . Alarmingly, an estimated 60-80% of Pakistani&#xD;
      population has been reported to have low HDL. There are a number of non-pharmacological and&#xD;
      pharmacological recommendations for management of low HDL. Non-pharmacological (functional&#xD;
      food) strategies are reported to increase HDL levels around 10-15% and which include regular&#xD;
      exercise , body weight reduction in obese individuals , cessation of cigarette smoking in&#xD;
      smokers and dietary modifications like decrease intake of saturated trans-fatty acids with&#xD;
      increase intake of omega-3 polyunsaturated fatty acids . There are also a number of&#xD;
      pharmacological agents being considered as therapeutic options but the tolerability and&#xD;
      safety issues limit their use in addition to limited success in improving HDL. IF may be a&#xD;
      dietary method to aid in the improvement of the lipid profile in healthy, obese and&#xD;
      dyslipidemia men and women, reducing total cholesterol, LDL, triglycerides and increasing HDL&#xD;
      levels. However, the majority of studies that analyze the IF impacts on the lipid profile and&#xD;
      body weight loss are observational and lack detailed information about diet. Randomized&#xD;
      clinical trials with larger sample size are needed to evaluate the IF effects mainly in&#xD;
      population with dyslipidemia.&#xD;
&#xD;
      HYPOTHESIS:&#xD;
&#xD;
      Intermittent fasting is capable of improving dyslipidemia and particularly enhancement of&#xD;
      serum, HDL which can increase the cardioprotection in high risk general population.&#xD;
&#xD;
      OBJECTIVES:&#xD;
&#xD;
      To evaluate the effect of intermittent fasting on cholesterol levels specifically on HDL.&#xD;
&#xD;
      DATA STORAGE AND MANAGEMENT:&#xD;
&#xD;
      Every participant will be given a code number, all data will be saved according to the code&#xD;
      numbers. Privacy will be maintain of each and every participant. Records will be kept&#xD;
      confidential and used only for scientific purposes by authorized personnel. The hard copies&#xD;
      will be kept in locked cupboards and soft data will be managed in password protected&#xD;
      computers. Data will be stored at institutional level for almost 15 years.&#xD;
&#xD;
      DISSEMINATION OF FINDINGS AND PUBLICATION PLAN:&#xD;
&#xD;
      Investigators expect that Ajwa and intermittent fasting will significantly improve HDL levels&#xD;
      in order to enhance the cardiac protection. This research will help in promoting the&#xD;
      significance of use of functional food and fasting to improve overall health. Investigators&#xD;
      expect at least two publications from this study. The findings of the study will be presented&#xD;
      in international conference and will be published in well reputed journal.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">February 20, 2019</start_date>
  <completion_date type="Anticipated">September 15, 2019</completion_date>
  <primary_completion_date type="Anticipated">June 1, 2019</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>
    <primary_purpose>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Lipid profile</measure>
    <time_frame>6 weeks</time_frame>
    <description>Change in HDL more than 3mg/dl Change in LDL more than 3mg/dl Cholesterol and TG</description>
  </primary_outcome>
  <primary_outcome>
    <measure>weight loss</measure>
    <time_frame>6 weeks</time_frame>
    <description>Change in body weight (kg), as measured by scale weight</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Blood pressure</measure>
    <time_frame>6 weeks</time_frame>
    <description>Reduction in systolic and diastolic</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Fasting Glucose</measure>
    <time_frame>6 weeks</time_frame>
    <description>Fasting glucose mg/dl</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Fasting Insulin</measure>
    <time_frame>6 weeks</time_frame>
    <description>Fasting insulin (IU/L)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Waist circumference Waist circumference (cm)</measure>
    <time_frame>6 weeks</time_frame>
    <description>WC in cm</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Lipid profile HbA1c (%) Lipids</measure>
    <time_frame>6 weeks</time_frame>
    <description>Total cholesterol (mg/dl), LDL cholesterol (mg/dl), HDL cholesterol (mg/dl), and triglycerides (mg/dl)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Waist circumference</measure>
    <time_frame>6 weeks</time_frame>
    <description>Waist circumference (cm)</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">60</enrollment>
  <condition>Intermittent Fasting</condition>
  <condition>Dyslipidemias</condition>
  <condition>HDL Cholesterol, Low Serum</condition>
  <condition>Hepatic Enzymes and Function Abnormalities</condition>
  <condition>Anemia</condition>
  <condition>Kidney Diseases</condition>
  <condition>Cardiac Function</condition>
  <arm_group>
    <arm_group_label>Interventional</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Will observe intermittent fasting</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Fasting (diet restruction for specific period)</intervention_name>
    <description>12-14 hours fasting</description>
    <arm_group_label>Interventional</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  General population with serum HDL less than 40 mg/dl for men and women&#xD;
&#xD;
          -  Adult ages 18- 80 years will be included in the study.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Individuals Patients already observing fasting regularly&#xD;
&#xD;
          -  Pregnant women and individuals with diabetes, metabolic syndrome or any other&#xD;
             co-morbidity will be excluded.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Aga Khan University</name>
      <address>
        <city>Karachi</city>
        <state>Sindh</state>
        <zip>74800</zip>
        <country>Pakistan</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Javeria Farooq, D. Pharm, Masters</last_name>
      <phone>02134860051</phone>
      <phone_ext>4493</phone_ext>
      <email>javeria.farooq@aku.edu</email>
    </contact>
  </location>
  <location_countries>
    <country>Pakistan</country>
  </location_countries>
  <reference>
    <citation>1. Aksungar FB, Eren A, Ure S, Teskin O, Ates G: Effects of intermittent fasting on serum lipid levels, coagulation status and plasma homocysteine levels. Annals of nutrition &amp; metabolism 2005, 49:77-82. 2. Ahmet I, Wan R, Mattson MP, Lakatta EG, Talan M: Cardioprotection by intermittent fasting in rats. Circulation 2005, 112:3115-3121. 3. Santos HO, Macedo RCO: Impact of intermittent fasting on the lipid profile: Assessment associated with diet and weight loss. Clinical nutrition ESPEN 2018, 24:14-21. 4. Adlouni A, Ghalim N, Saı̈le R, Hda N, Parra H-J, Benslimane A: Beneficial effect on serum apo AI, apo B and Lp AI levels of Ramadan fasting. Clinica Chimica Acta 1998, 271:179-189. 5. Hammouda O, Chtourou H, Aloui A, Chahed H, Kallel C, Miled A, Chamari K, Chaouachi A, Souissi N: Concomitant effects of Ramadan fasting and time-of-day on apolipoprotein AI, B, Lp-a and homocysteine responses during aerobic exercise in Tunisian soccer players. PloS one 2013, 8:e79873.</citation>
  </reference>
  <verification_date>February 2019</verification_date>
  <study_first_submitted>January 14, 2019</study_first_submitted>
  <study_first_submitted_qc>January 15, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 16, 2019</study_first_posted>
  <last_update_submitted>February 20, 2019</last_update_submitted>
  <last_update_submitted_qc>February 20, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">February 21, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Aga Khan University</investigator_affiliation>
    <investigator_full_name>NASEER AHMED</investigator_full_name>
    <investigator_title>Assistant Professor</investigator_title>
  </responsible_party>
  <keyword>Intermittent fasting</keyword>
  <keyword>Fasting</keyword>
  <keyword>Cholesterol</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Kidney Diseases</mesh_term>
    <mesh_term>Hypoalphalipoproteinemias</mesh_term>
    <mesh_term>Dyslipidemias</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</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/NCT03805776
org study id: 123
nct id: NCT03805776
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
World Health Organization report notifies of the escalating global burden of cardiovascular
      diseases (CVD), projecting that it will become the major worldwide cause of death and
      disability by 2020. The South Asian countries have the highest rates of CVD globally. It is
      widely acknowledged that South Asians have 40-60% higher risk of CVD linked to mortality,
      compared with other populations. Multiple human population studies have established the
      concentration of high density lipoprotein (HDL) cholesterol as an independent, inverse
      predictor of the risk of having a cardiovascular event. Furthermore, HDLs have several
      well-documented functions with the potential to protect against cardiovascular disease. This
      study trial is designed to find out the role of intermittent fasting to improve the
      dyslipidemia and particularly increase the levels of HDL in general population. Investigators
      expect that the intermittent fasting will significantly enhance the level of HDL and reduce
      cardiovascular events in general population.
INTRODUCTION:

      Overall lipid profile is important in cardiovascular diseases but particularly serum HDL
      levels have long been recognized as an independent inverse prognostic marker of CVD, when the
      Framigham study, in 1980s showed that HDL below 40-60mg/dl is of prognostic relevance. A rise
      of 1mg/dl in HDL levels is considered to reduce coronary artery disease (CAD) risk to 2-3%.
      Even patients with elevated total cholesterol (TC) and LDL, presenting a high HDL are seen to
      be protected from atherosclerosis. Multiple human population studies have shown the
      concentration of HDL cholesterol as an independent, inverse predictor of the risk of having a
      cardiovascular event. Additionally, HDL has several well-documented functions with the
      potential to protect against cardiovascular diseases. These include an ability to promote the
      efflux of cholesterol from macrophages in the artery wall, inhibit the oxidative modification
      of LDL, inhibit vascular inflammation, inhibit thrombosis, promote endothelial repair,
      promote angiogenesis, anti-oxidant, enhance endothelial function, improve diabetic control,
      and inhibit hematopoietic stem cell proliferation. HDL also exerts direct cardio protective
      effect, which are mediated with its interactions with the myocardium.

      Various studies have emphasised the high incidence of CVD within the South Asian countries.
      The increased risk of cardiovascular events in South Asians at a younger age might be due to
      unknown factors affecting plaque rupture, the interaction between prothrombotic factors and
      atherosclerosis, or may be due to any undiscovered risk factors. Urbanisation and
      westernisation is characterised by a distinct increase in the intake of energy dense foods, a
      decrease in physical activity, and a heightened level of psychosocial stress, all of which
      promote the development of hyperglycaemia, hypertension, and dyslipidaemia. Most common
      dyslipidaemia in South Asians is low HDL-C and high triglycerides. High triglyceride and low
      HDL-C levels are metabolically interlinked. This metabolic phenotype is also associated with
      increased levels of small LDL particles despite relatively normal levels of LDL-C among South
      Asians. This clinical syndrome is accompanied by insulin resistance, a condition frequently
      referred to as atherogenic dyslipidemia, which is a common metabolic derangement among Asian.
      South Asians not only have lower HDL levels but also have a higher concentration of small,
      less-protective HDL particles. One proposed mechanism is presence of dysfunctional HDL
      particles. Another potential explanation for the apparent blunted cardioprotection of HDL in
      South Asians might be related to HDL particle size. Small particles might be less efficient
      in reverse cholesterol transport. In general, HDL particle size tends to be lower in patients
      with CHD and those with low HDL-C levels . Alarmingly, an estimated 60-80% of Pakistani
      population has been reported to have low HDL. There are a number of non-pharmacological and
      pharmacological recommendations for management of low HDL. Non-pharmacological (functional
      food) strategies are reported to increase HDL levels around 10-15% and which include regular
      exercise , body weight reduction in obese individuals , cessation of cigarette smoking in
      smokers and dietary modifications like decrease intake of saturated trans-fatty acids with
      increase intake of omega-3 polyunsaturated fatty acids . There are also a number of
      pharmacological agents being considered as therapeutic options but the tolerability and
      safety issues limit their use in addition to limited success in improving HDL. IF may be a
      dietary method to aid in the improvement of the lipid profile in healthy, obese and
      dyslipidemia men and women, reducing total cholesterol, LDL, triglycerides and increasing HDL
      levels. However, the majority of studies that analyze the IF impacts on the lipid profile and
      body weight loss are observational and lack detailed information about diet. Randomized
      clinical trials with larger sample size are needed to evaluate the IF effects mainly in
      population with dyslipidemia.

      HYPOTHESIS:

      Intermittent fasting is capable of improving dyslipidemia and particularly enhancement of
      serum, HDL which can increase the cardioprotection in high risk general population.

      OBJECTIVES:

      To evaluate the effect of intermittent fasting on cholesterol levels specifically on HDL.

      DATA STORAGE AND MANAGEMENT:

      Every participant will be given a code number, all data will be saved according to the code
      numbers. Privacy will be maintain of each and every participant. Records will be kept
      confidential and used only for scientific purposes by authorized personnel. The hard copies
      will be kept in locked cupboards and soft data will be managed in password protected
      computers. Data will be stored at institutional level for almost 15 years.

      DISSEMINATION OF FINDINGS AND PUBLICATION PLAN:

      Investigators expect that Ajwa and intermittent fasting will significantly improve HDL levels
      in order to enhance the cardiac protection. This research will help in promoting the
      significance of use of functional food and fasting to improve overall health. Investigators
      expect at least two publications from this study. The findings of the study will be presented
      in international conference and will be published in well reputed journal.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: Lipid profile
time frame: 6 weeks
description: Change in HDL more than 3mg/dl Change in LDL more than 3mg/dl Cholesterol and TG
measure: weight loss
time frame: 6 weeks
description: Change in body weight (kg), as measured by scale weight
measure: Blood pressure
time frame: 6 weeks
description: Reduction in systolic and diastolic
measure: Fasting Glucose
time frame: 6 weeks
description: Fasting glucose mg/dl
measure: Fasting Insulin
time frame: 6 weeks
description: Fasting insulin (IU/L)
measure: Waist circumference Waist circumference (cm)
time frame: 6 weeks
description: WC in cm
measure: Lipid profile HbA1c (%) Lipids
time frame: 6 weeks
description: Total cholesterol (mg/dl), LDL cholesterol (mg/dl), HDL cholesterol (mg/dl), and triglycerides (mg/dl)
measure: Waist circumference
time frame: 6 weeks
description: Waist circumference (cm)
arm group label: Interventional
arm group type: Experimental
description: Will observe intermittent fasting
arm group label: Control
arm group type: No Intervention
intervention type: Other
intervention name: Fasting (diet restruction for specific period)
description: 12-14 hours fasting
arm group label: Interventional
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
status: Recruiting
contact: 
country: Pakistan
citation: 1. Aksungar FB, Eren A, Ure S, Teskin O, Ates G: Effects of intermittent fasting on serum lipid levels, coagulation status and plasma homocysteine levels. Annals of nutrition & metabolism 2005, 49:77-82. 2. Ahmet I, Wan R, Mattson MP, Lakatta EG, Talan M: Cardioprotection by intermittent fasting in rats. Circulation 2005, 112:3115-3121. 3. Santos HO, Macedo RCO: Impact of intermittent fasting on the lipid profile: Assessment associated with diet and weight loss. Clinical nutrition ESPEN 2018, 24:14-21. 4. Adlouni A, Ghalim N, Saı̈le R, Hda N, Parra H-J, Benslimane A: Beneficial effect on serum apo AI, apo B and Lp AI levels of Ramadan fasting. Clinica Chimica Acta 1998, 271:179-189. 5. Hammouda O, Chtourou H, Aloui A, Chahed H, Kallel C, Miled A, Chamari K, Chaouachi A, Souissi N: Concomitant effects of Ramadan fasting and time-of-day on apolipoprotein AI, B, Lp-a and homocysteine responses during aerobic exercise in Tunisian soccer players. PloS one 2013, 8:e79873.
responsible party type: Principal Investigator
investigator affiliation: Aga Khan University
investigator full name: NASEER AHMED
investigator title: Assistant Professor
mesh term: Kidney Diseases
mesh term: Hypoalphalipoproteinemias
mesh term: Dyslipidemias
sharing ipd: No