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

• Sponsor: University of Illinois at Chicago (Other)
• Overall Status: Completed
• CT.gov ID: NCT00960505
• Collaborator: Pennington Biomedical Research Center (Other), National Heart, Lung, and Blood Institute (NHLBI) (NIH)
• Enrollment: 100
• Location: 1
• Arms: 3
• Duration (Months): 52
• Patients Per Site Per Month: 1.9

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Coronary Heart Disease; Obesity; Weight Loss	Other: Alternate day fasting; Other: Calorie restriction; Other: Control diet	N/A

Detailed Description

Overweight and obese individuals are at increased risk for coronary heart disease (CHD). Losing weight by means of dietary restriction greatly reduces vascular disease risk. The majority of studies examiningmost common dietary restriction protocol s implemented is daily calorie restriction (CR). Another dietary restriction regimen employed, although far less commonly, is alternate day modified fasting (ADMF). ADMF involves a "feed day" where food is consumed ad-libitum, alternated with a "fast day", where food intake is partially reduced. Previous reports show that adherence to ADMF exceeds that of CR after 8 weeks of treatment. This increased adherence to ADMF results in greater weight loss, which produces more pronounced improvements in CHD risk. What has yet to be determined is whether adherence to ADMF remains near maximal for longer treatment durations (24 weeks), and if this improved adherence results in greater reductions in body weight and CHD risk, versus CR. Once weight loss is achieved, weight maintenance is extremely important as CHD risk can increase if weight is regained. Whether ADMF is an effective strategy for weight maintenance remains unknown. Accordingly, the aims of this proposal are: Aim 1: To establish that adherence to ADMF is greater than that of CR during a 24-week intervention period and to determine if increased adherence to ADMF results in greater weight loss; Aim 2: To establish that greater reductions in body weight by ADMF over a 24-week period will result in greater improvements in traditional CHD risk parameters (blood pressure, plasma lipid levels, cholesterol synthesis rate, LDL particle size, and CRP) and emerging CHD risk parameters (fat cell-derived hormones, body fat distribution, and fat cell size) in comparison to CR; and Aim 3: To establish that ADMF is an effective diet therapy to maintain weight loss and sustain improvements in CHD risk indicators, and to compare changes in cognitive and behavioral components of eating between ADMF and CR subjects. A 52-week randomized, controlled, parallel-arm feeding trial will be implemented to test these objectives. The trial will be divided into 3 consecutive intervention periods: (1) 4-week baseline; (2) 24-week weight loss with food provided; and (3) 24-week weight maintenance with no food provided. Overweight and obese subjects (n = 90) will be randomized to 1 of 3 groups: (1) ADMF, 75% energy restriction on the "fast day" and ad libitum fed on the "feed day"; (2) CR, 25% restriction everyday; or 3) control, 100% energy intake everyday. During the weight maintenance phase, ADMF subjects will consume 25% of their energy needs on the "fast day" and 175% of their needs on the "feed day", while CR and control subjects will consume 100% of their needs everyday. Our findings will show that ADMF can be implemented as an alternative to CR to help overweight and obese individuals lose weight, maintain weight loss, and sustain reductions in CHD risk. This study will also generate insights into the specific behavioral changes that occur with ADMF that explain why ADMF is a successful diet strategy for weight maintenance.

Study Design

• Study Type: Interventional
• Actual Enrollment: 100 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Prevention
• Official Title: Alternate Day Fasting for Weight Loss, Weight Maintenance and Cardio-protection
• Study Start Date: Sep 1, 2010
• Actual Primary Completion Date: Jan 1, 2015
• Actual Study Completion Date: Jan 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Alternate day fasting (ADF) Fast day diet: 25% energy intake, Feast day diet: Ad libitum energy intake (alternating days)	Other: Alternate day fasting
Experimental: Calorie restriction (CR) 75% energy intake every day	Other: Calorie restriction
Active Comparator: Control Usual diet	Other: Control diet

Outcome Measures

Primary Outcome Measures

1. Body Weight [Baseline to month 12]

   Change in body weight from baseline to month 12

Secondary Outcome Measures

1. Change in HDL Cholesterol [12 month interval]

   Change in HDL cholesterol from baseline to month 12

2. Change in Systolic Blood Pressure [12 month interval]

   Change in systolic blood pressure from baseline to month 12

3. Change in Fasting Glucose [12 month interval]

   Change in fasting glucose from baseline to month 12

4. Change in Fasting Insulin [12 month interval]

   Change in fasting insulin from baseline to month 12

5. Change in Insulin Resistance Measured by HOMA-IR [12 month interval]

   Change in insulin resistance measured by HOMA-IR from baseline to month 12

6. Change in Plasma C-reactive Protein Concentrations [12 month interval]

   Change in plasma C-reactive protein concentrations from baseline to month 12

7. Change in Plasma Homocysteine Concentrations [12 month interval]

   Change in plasma Homocysteine concentrations from baseline to month 12

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion criteria. Adult subjects meeting the following criteria will be eligible to participate:

• 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)

Exclusion criteria. Subjects excluded from participating in the study include those who:

• 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Illinois, Chicago	Chicago	Illinois	United States	60622

Sponsors and Collaborators

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

Investigators

• Principal Investigator: Krista Varady, PhD, University of Illinois, Chicago

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Krista Varady, Associate Professor, University of Illinois at Chicago
• ClinicalTrials.gov Identifier: NCT00960505
• Other Study ID Numbers: 2010-0118; R01HL106228
• First Posted: Aug 17, 2009
• Last Update Posted: Jul 21, 2020
• Last Verified: Jul 1, 2020

• Keywords provided by Krista Varady, Associate Professor, University of Illinois at Chicago: Diet; Coronary heart disease; Obesity; Weight loss; Weight maintenance
• Additional relevant MeSH terms: Heart Diseases; Coronary Disease; Coronary Artery Disease; Myocardial Ischemia; Body Weight; Weight Loss

Study Results

Participant Flow

Arm/Group Title	Alternate Day Fasting (ADF)	Calorie Restriction (CR)	Control
Arm/Group Description	Fast day diet: 25% energy intake, Feast day diet: Ad libitum energy intake (alternating days) Alternate day fasting	75% energy intake every day Calorie restriction	Usual diet Control diet
Period Title: Overall Study
STARTED	34	35	31
COMPLETED	21	25	23
NOT COMPLETED	13	10	8

Baseline Characteristics

Arm/Group Title	Alternate Day Fasting (ADF)	Calorie Restriction (CR)	Control	Total
Arm/Group Description	Fast day diet: 25% energy intake, Feast day diet: Ad libitum energy intake (alternating days) Alternate day fasting	75% energy intake every day Calorie restriction	Usual diet Control diet	Total of all reporting groups
Overall Participants	34	35	31	100
Age (Years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Years]	44 (10)	43 (12)	44 (11)	44 (11)
Sex: Female, Male (Count of Participants)
Female	30 88.2%	29 82.9%	27 87.1%	86 86%
Male	4 11.8%	6 17.1%	4 12.9%	14 14%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	2 5.9%	1 2.9%	0 0%	3 3%
Not Hispanic or Latino	32 94.1%	34 97.1%	31 100%	97 97%
Unknown or Not Reported	0 0%	0 0%	0 0%	0 0%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	0 0%	0 0%	0 0%
Asian	1 2.9%	1 2.9%	0 0%	2 2%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%	0 0%
Black or African American	22 64.7%	21 60%	20 64.5%	63 63%
White	11 32.4%	13 37.1%	11 35.5%	35 35%
More than one race	0 0%	0 0%	0 0%	0 0%
Unknown or Not Reported	0 0%	0 0%	0 0%	0 0%

Outcome Measures

1. Primary Outcome

Title	Body Weight
Description	Change in body weight from baseline to month 12
Time Frame	Baseline to month 12

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Alternate Day Fasting (ADF)	Calorie Restriction (CR)	Control
Arm/Group Description	Fast day diet: 25% energy intake, Feast day diet: Ad libitum energy intake (alternating days) Alternate day fasting	75% energy intake every day Calorie restriction	Usual diet
Measure Participants	34	35	31
Mean (Standard Error) [Percent change at month 12]	-4.6 (0.9)	-4.5 (0.9)	0.3 (0.6)

2. Secondary Outcome

Title	Change in HDL Cholesterol
Description	Change in HDL cholesterol from baseline to month 12
Time Frame	12 month interval

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Alternate Day Fasting (ADF)	Calorie Restriction (CR)	Control
Arm/Group Description	Fast day diet: 25% energy intake, Feast day diet: Ad libitum energy intake (alternating days) Alternate day fasting	75% energy intake every day Calorie restriction	Usual diet
Measure Participants	34	35	31
Mean (Standard Error) [Percent change from baseline to month 12]	4.6 (3.1)	-0.5 (3.1)	-3.4 (3.9)

3. Secondary Outcome

Title	Change in Systolic Blood Pressure
Description	Change in systolic blood pressure from baseline to month 12
Time Frame	12 month interval

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Alternate Day Fasting (ADF)	Calorie Restriction (CR)	Control
Arm/Group Description	Fast day diet: 25% energy intake, Feast day diet: Ad libitum energy intake (alternating days) Alternate day fasting	75% energy intake every day Calorie restriction	Usual diet
Measure Participants	34	35	31
Mean (Standard Error) [Percent change from baseline to month 12]	-3.5 (2.3)	-2.9 (2.0)	-2.6 (4.0)

4. Secondary Outcome

Title	Change in Fasting Glucose
Description	Change in fasting glucose from baseline to month 12
Time Frame	12 month interval

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Alternate Day Fasting (ADF)	Calorie Restriction (CR)	Control
Arm/Group Description	Fast day diet: 25% energy intake, Feast day diet: Ad libitum energy intake (alternating days) Alternate day fasting	75% energy intake every day Calorie restriction	Usual diet
Measure Participants	34	35	31
Mean (Standard Error) [Percent change from baseline to month 12]	4.0 (2.0)	-1.9 (3.3)	10.7 (3.4)

5. Secondary Outcome

Title	Change in Fasting Insulin
Description	Change in fasting insulin from baseline to month 12
Time Frame	12 month interval

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Alternate Day Fasting (ADF)	Calorie Restriction (CR)	Control
Arm/Group Description	Fast day diet: 25% energy intake, Feast day diet: Ad libitum energy intake (alternating days) Alternate day fasting	75% energy intake every day Calorie restriction	Usual diet
Measure Participants	34	35	31
Mean (Standard Error) [Percent change from baseline to month 12]	-35 (11)	-28 (9)	-2.5 (13)

6. Secondary Outcome

Title	Change in Insulin Resistance Measured by HOMA-IR
Description	Change in insulin resistance measured by HOMA-IR from baseline to month 12
Time Frame	12 month interval

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Alternate Day Fasting (ADF)	Calorie Restriction (CR)	Control
Arm/Group Description	Fast day diet: 25% energy intake, Feast day diet: Ad libitum energy intake (alternating days) Alternate day fasting	75% energy intake every day Calorie restriction	Usual diet
Measure Participants	34	35	31
Mean (Standard Error) [Percent change from baseline to month 12]	-36 (13)	-34 (12)	12 (16)

7. Secondary Outcome

Title	Change in Plasma C-reactive Protein Concentrations
Description	Change in plasma C-reactive protein concentrations from baseline to month 12
Time Frame	12 month interval

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Alternate Day Fasting (ADF)	Calorie Restriction (CR)	Control
Arm/Group Description	Fast day diet: 25% energy intake, Feast day diet: Ad libitum energy intake (alternating days) Alternate day fasting	75% energy intake every day Calorie restriction	Usual diet
Measure Participants	34	35	31
Mean (Standard Error) [Percent change from baseline to month 12]	-13.9 (11.7)	-6.2 (8.1)	5.4 (16.8)

8. Secondary Outcome

Title	Change in Plasma Homocysteine Concentrations
Description	Change in plasma Homocysteine concentrations from baseline to month 12
Time Frame	12 month interval

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Alternate Day Fasting (ADF)	Calorie Restriction (CR)	Control
Arm/Group Description	Fast day diet: 25% energy intake, Feast day diet: Ad libitum energy intake (alternating days) Alternate day fasting	75% energy intake every day Calorie restriction	Usual diet
Measure Participants	34	35	31
Mean (Standard Error) [Percent change from baseline to month 12]	0.2 (4.3)	-1.2 (3.2)	-2.6 (3.3)

Adverse Events

Time Frame	12 months
Arm/Group Title	Alternate Day Fasting (ADF)		Calorie Restriction (CR)		Control
Arm/Group Description	Fast day diet: 25% energy intake, Feast day diet: Ad libitum energy intake (alternating days) Alternate day fasting		75% energy intake every day Calorie restriction		Usual diet Control diet
All Cause Mortality
	Alternate Day Fasting (ADF)		Calorie Restriction (CR)		Control
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/34 (0%)		0/35 (0%)		0/31 (0%)
Serious Adverse Events
	Alternate Day Fasting (ADF)		Calorie Restriction (CR)		Control
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/34 (0%)		0/35 (0%)		0/31 (0%)
Other (Not Including Serious) Adverse Events
	Alternate Day Fasting (ADF)		Calorie Restriction (CR)		Control
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/34 (0%)		0/35 (0%)		0/31 (0%)

Limitations/Caveats

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

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.