Alternate Day Fasting for Weight Loss, Weight Maintenance and Cardio-protection

NCT00960505 | Completed Results DMC

• 2 other identifiers: 2010-0118R01HL106228
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

The proposed research will demonstrate that alternate day modified fasting (ADMF) is a suitable alternative to daily calorie restriction (CR) for weight loss, weight maintenance, and heart disease prevention. Since many overweight and obese individuals find it difficult to adhere to daily CR, this diet option may improve adherence with these dietary restriction protocols. This, in turn, will allow a greater percent of the overweight and obese population to lose weight, maintain weight loss, and prevent future occurrences of coronary heart disease.

Conditions

Coronary Heart Disease; Obesity; Weight Loss

Keywords

Diet; Coronary heart disease; Obesity; Weight loss; Weight maintenance

Outcome Measures

Primary Outcomes (1)

• Body Weight

  Change in body weight from baseline to month 12

  Baseline to month 12

Secondary Outcomes (7)

• Change in HDL Cholesterol

  12 month interval

• Change in Systolic Blood Pressure

  12 month interval

• Change in Fasting Glucose

  12 month interval

• Change in Fasting Insulin

  12 month interval

• Change in Insulin Resistance Measured by HOMA-IR

  12 month interval

Study Arms (3)

Alternate day fasting (ADF)

EXPERIMENTAL

Fast day diet: 25% energy intake, Feast day diet: Ad libitum energy intake (alternating days)

Other: Alternate day fasting

Calorie restriction (CR)

EXPERIMENTAL

75% energy intake every day

Other: Calorie restriction

Control

ACTIVE COMPARATOR

Usual diet

Other: Control diet

Interventions

Alternate day fasting OTHER

Alternate day fasting (ADF)

Calorie restriction OTHER

Calorie restriction (CR)

Control diet OTHER

Control

Eligibility Criteria

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

You may qualify if:

• Age between 18 to 65 years old
• BMI between 25.0 and 39.9 kg/m2
• Previously sedentary (\<60 minutes/week of light activity corresponding to 2.5 to 4.0 metabolic equivalents (METs) for the 3 months prior to the study)

You may not qualify if:

• Have a history cardiovascular disease (prior angina, myocardial infarction or stroke)
• Are diabetic (fasting blood glucose \> 126 mg/dl)
• Have a history of psychiatric disorders and/or eating disorders
• Are taking anti-depressant or anti-anxiety medications
• Are taking drugs that affect study outcomes (weight loss, lipid-lowering, or blood pressure drugs)
• Are not weight stable for 3 months prior to the beginning of study (weight gain or loss \> 4 kg)
• Are not able to keep a food diary or activity log for 7 consecutive days during screening
• Are perimenopausal or have an irregular menstrual cycle (menses that does not appear every 27-32 days)
• Are claustrophobic or have implanted electrical devices (cardiac pacemaker or a neurostimulator)
• Are pregnant, or trying to become pregnant
• Are smokers

Sponsors & Collaborators

• University of Illinois at Chicago: lead
• Pennington Biomedical Research Center: collaborator
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (1)

University of Illinois, Chicago

Chicago, Illinois, 60622, United States

Location

Related Publications (6)

• Allaf M, Elghazaly H, Mohamed OG, Fareen MFK, Zaman S, Salmasi AM, Tsilidis K, Dehghan A. Intermittent fasting for the prevention of cardiovascular disease. Cochrane Database Syst Rev. 2021 Jan 29;1(1):CD013496. doi: 10.1002/14651858.CD013496.pub2.

  PMID: 33512717 DERIVED

• Lin S, Lima Oliveira M, Gabel K, Kalam F, Cienfuegos S, Ezpeleta M, Bhutani S, Varady KA. Does the weight loss efficacy of alternate day fasting differ according to sex and menopausal status? Nutr Metab Cardiovasc Dis. 2021 Feb 8;31(2):641-649. doi: 10.1016/j.numecd.2020.10.018. Epub 2020 Oct 31.

  PMID: 33358713 DERIVED

• Gabel K, Kroeger CM, Trepanowski JF, Hoddy KK, Cienfuegos S, Kalam F, Varady KA. Differential Effects of Alternate-Day Fasting Versus Daily Calorie Restriction on Insulin Resistance. Obesity (Silver Spring). 2019 Sep;27(9):1443-1450. doi: 10.1002/oby.22564. Epub 2019 Jul 22.

  PMID: 31328895 DERIVED

• Miranda ER, Fuller KNZ, Perkins RK, Kroeger CM, Trepanowski JF, Varady KA, Haus JM. Endogenous secretory RAGE increases with improvements in body composition and is associated with markers of adipocyte health. Nutr Metab Cardiovasc Dis. 2018 Nov;28(11):1155-1165. doi: 10.1016/j.numecd.2018.07.009. Epub 2018 Aug 2.

  PMID: 30297199 DERIVED

• Trepanowski JF, Kroeger CM, Barnosky A, Klempel M, Bhutani S, Hoddy KK, Rood J, Ravussin E, Varady KA. Effects of alternate-day fasting or daily calorie restriction on body composition, fat distribution, and circulating adipokines: Secondary analysis of a randomized controlled trial. Clin Nutr. 2018 Dec;37(6 Pt A):1871-1878. doi: 10.1016/j.clnu.2017.11.018. Epub 2017 Dec 5.

  PMID: 29258678 DERIVED

• Trepanowski JF, Kroeger CM, Barnosky A, Klempel MC, Bhutani S, Hoddy KK, Gabel K, Freels S, Rigdon J, Rood J, Ravussin E, Varady KA. Effect of Alternate-Day Fasting on Weight Loss, Weight Maintenance, and Cardioprotection Among Metabolically Healthy Obese Adults: A Randomized Clinical Trial. JAMA Intern Med. 2017 Jul 1;177(7):930-938. doi: 10.1001/jamainternmed.2017.0936.

  PMID: 28459931 DERIVED

MeSH Terms

Conditions

Coronary Disease; Obesity; Weight Loss

Interventions

Caloric Restriction

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Body Weight Changes

Intervention Hierarchy (Ancestors)

Diet Therapy; Nutrition Therapy; Therapeutics; Energy Intake; Diet; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Limitations and Caveats

1. The duration of the maintenance phase was short (6 months). 2. The dropout rate was higher than anticipated. 3. We enrolled predominantly metabolically healthy obese individuals.

Results Point of Contact

• Title: Krista Varady, PhD, Associate Professor
• Organization: University of Illinois Chicago

varady@uic.edu

3129967897

Study Officials

• Krista Varady, PhD

  University of Illinois Chicago

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

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: Associate Professor

Study Record Dates

• First Submitted: August 14, 2009
• First Posted: August 17, 2009
• Study Start: September 1, 2010
• Primary Completion: January 1, 2015
• Study Completion: January 1, 2015
• Last Updated: July 21, 2020
• Results First Posted: July 9, 2020

Record last verified: 2020-07

Locations

US (1)