Intermittent Fasting in Dyslipidemia

NCT03805776 | Unknown DMC

• 1 other identifier: 123
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Intermittent Fasting; Dyslipidemias; HDL Cholesterol, Low Serum; Hepatic Enzymes and Function Abnormalities; Anemia; Kidney Diseases; Cardiac Function

Keywords

Intermittent fasting; Fasting; Cholesterol

Outcome Measures

Primary Outcomes (3)

• Lipid profile

  Change in HDL more than 3mg/dl Change in LDL more than 3mg/dl Cholesterol and TG

  6 weeks

• weight loss

  Change in body weight (kg), as measured by scale weight

  6 weeks

• Blood pressure

  Reduction in systolic and diastolic

  6 weeks

Secondary Outcomes (5)

• Fasting Glucose

  6 weeks

• Fasting Insulin

  6 weeks

• Waist circumference Waist circumference (cm)

  6 weeks

• Lipid profile HbA1c (%) Lipids

  6 weeks

• Waist circumference

  6 weeks

Study Arms (2)

Interventional

EXPERIMENTAL

Will observe intermittent fasting

Other: Fasting (diet restruction for specific period)

Control

NO INTERVENTION

Interventions

Fasting (diet restruction for specific period) OTHER

12-14 hours fasting

Interventional

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Aga Khan University: lead

Study Sites (1)

Aga Khan University

Karachi, Sindh, 74800, Pakistan

RECRUITING

Related Publications (2)

• 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.

  BACKGROUND

• Ahmed N, Farooq J, Siddiqi HS, Meo SA, Kulsoom B, Laghari AH, Jamshed H, Pasha F. Impact of Intermittent Fasting on Lipid Profile-A Quasi-Randomized Clinical Trial. Front Nutr. 2021 Feb 1;7:596787. doi: 10.3389/fnut.2020.596787. eCollection 2020.

  PMID: 33598473 DERIVED

MeSH Terms

Conditions

Intermittent Fasting; Dyslipidemias; Hypoalphalipoproteinemias; Anemia; Kidney Diseases; Fasting

Condition Hierarchy (Ancestors)

Feeding Behavior; Behavior; Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Hypolipoproteinemias; Lipid Metabolism, Inborn Errors; Metabolism, Inborn Errors; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Hematologic Diseases; Hemic and Lymphatic Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: January 14, 2019
• First Posted: January 16, 2019
• Study Start: February 20, 2019
• Primary Completion: June 1, 2019
• Study Completion: September 15, 2019
• Last Updated: February 21, 2019

Record last verified: 2019-02

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)