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Intermittent Fasting in Dyslipidemia

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ClinicalTrials.gov Identifier: NCT03805776
Recruitment Status : Recruiting
First Posted : January 16, 2019
Last Update Posted : February 21, 2019
Sponsor:
Information provided by (Responsible Party):
NASEER AHMED, Aga Khan University

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Intermittent Fasting Dyslipidemias HDL Cholesterol, Low Serum Hepatic Enzymes and Function Abnormalities Anemia Kidney Diseases Cardiac Function Other: Fasting (diet restruction for specific period) Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Role of Intermittent Fasting in Improving High Density Lipoprotein Cholesterol
Actual Study Start Date : February 20, 2019
Estimated Primary Completion Date : June 1, 2019
Estimated Study Completion Date : September 15, 2019


Arm Intervention/treatment
Experimental: Interventional
Will observe intermittent fasting
Other: Fasting (diet restruction for specific period)
12-14 hours fasting

No Intervention: Control



Primary Outcome Measures :
  1. Lipid profile [ Time Frame: 6 weeks ]
    Change in HDL more than 3mg/dl Change in LDL more than 3mg/dl Cholesterol and TG

  2. weight loss [ Time Frame: 6 weeks ]
    Change in body weight (kg), as measured by scale weight

  3. Blood pressure [ Time Frame: 6 weeks ]
    Reduction in systolic and diastolic


Secondary Outcome Measures :
  1. Fasting Glucose [ Time Frame: 6 weeks ]
    Fasting glucose mg/dl

  2. Fasting Insulin [ Time Frame: 6 weeks ]
    Fasting insulin (IU/L)

  3. Waist circumference Waist circumference (cm) [ Time Frame: 6 weeks ]
    WC in cm

  4. Lipid profile HbA1c (%) Lipids [ Time Frame: 6 weeks ]
    Total cholesterol (mg/dl), LDL cholesterol (mg/dl), HDL cholesterol (mg/dl), and triglycerides (mg/dl)

  5. Waist circumference [ Time Frame: 6 weeks ]
    Waist circumference (cm)



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • General population with serum HDL less than 40 mg/dl for men and women
  • Adult ages 18- 80 years will be included in the study.

Exclusion Criteria:

  • Individuals Patients already observing fasting regularly
  • Pregnant women and individuals with diabetes, metabolic syndrome or any other co-morbidity will be excluded.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03805776


Locations
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Pakistan
Aga Khan University Recruiting
Karachi, Sindh, Pakistan, 74800
Contact: Javeria Farooq, D. Pharm, Masters    02134860051 ext 4493    javeria.farooq@aku.edu   
Sponsors and Collaborators
Aga Khan University

Publications:
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Responsible Party: NASEER AHMED, Assistant Professor, Aga Khan University
ClinicalTrials.gov Identifier: NCT03805776     History of Changes
Other Study ID Numbers: 123
First Posted: January 16, 2019    Key Record Dates
Last Update Posted: February 21, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by NASEER AHMED, Aga Khan University:
Intermittent fasting
Fasting
Cholesterol
Additional relevant MeSH terms:
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Kidney Diseases
Hypoalphalipoproteinemias
Dyslipidemias
Urologic Diseases
Lipid Metabolism Disorders
Metabolic Diseases
Hypolipoproteinemias
Lipid Metabolism, Inborn Errors
Metabolism, Inborn Errors
Genetic Diseases, Inborn