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

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ClinicalTrials.gov Identifier: NCT00960505
Recruitment Status : Completed
First Posted : August 17, 2009
Results First Posted : July 9, 2020
Last Update Posted : July 21, 2020
Sponsor:
Collaborators:
Pennington Biomedical Research Center
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
Krista Varady, University of Illinois at Chicago

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Prevention
Conditions Coronary Heart Disease
Obesity
Weight Loss
Interventions Other: Alternate day fasting
Other: Calorie restriction
Other: Control diet
Enrollment 100
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Alternate Day Fasting (ADF) Calorie Restriction (CR) Control
Hide 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
Arm/Group Title Alternate Day Fasting (ADF) Calorie Restriction (CR) Control Total
Hide 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 Number of Baseline Participants 34 35 31 100
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 34 participants 35 participants 31 participants 100 participants
44  (10) 43  (12) 44  (11) 44  (11)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 34 participants 35 participants 31 participants 100 participants
Female
30
  88.2%
29
  82.9%
27
  87.1%
86
  86.0%
Male
4
  11.8%
6
  17.1%
4
  12.9%
14
  14.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 34 participants 35 participants 31 participants 100 participants
Hispanic or Latino
2
   5.9%
1
   2.9%
0
   0.0%
3
   3.0%
Not Hispanic or Latino
32
  94.1%
34
  97.1%
31
 100.0%
97
  97.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 34 participants 35 participants 31 participants 100 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Asian
1
   2.9%
1
   2.9%
0
   0.0%
2
   2.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
22
  64.7%
21
  60.0%
20
  64.5%
63
  63.0%
White
11
  32.4%
13
  37.1%
11
  35.5%
35
  35.0%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
1.Primary Outcome
Title Body Weight
Hide Description Change in body weight from baseline to month 12
Time Frame Baseline to month 12
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Alternate Day Fasting (ADF) Calorie Restriction (CR) Control
Hide 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
Overall Number of Participants Analyzed 34 35 31
Mean (Standard Error)
Unit of Measure: 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
Hide Description Change in HDL cholesterol from baseline to month 12
Time Frame 12 month interval
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Alternate Day Fasting (ADF) Calorie Restriction (CR) Control
Hide 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
Overall Number of Participants Analyzed 34 35 31
Mean (Standard Error)
Unit of Measure: 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
Hide Description Change in systolic blood pressure from baseline to month 12
Time Frame 12 month interval
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Alternate Day Fasting (ADF) Calorie Restriction (CR) Control
Hide 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
Overall Number of Participants Analyzed 34 35 31
Mean (Standard Error)
Unit of Measure: 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
Hide Description Change in fasting glucose from baseline to month 12
Time Frame 12 month interval
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Alternate Day Fasting (ADF) Calorie Restriction (CR) Control
Hide 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
Overall Number of Participants Analyzed 34 35 31
Mean (Standard Error)
Unit of Measure: 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
Hide Description Change in fasting insulin from baseline to month 12
Time Frame 12 month interval
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Alternate Day Fasting (ADF) Calorie Restriction (CR) Control
Hide 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
Overall Number of Participants Analyzed 34 35 31
Mean (Standard Error)
Unit of Measure: 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
Hide Description Change in insulin resistance measured by HOMA-IR from baseline to month 12
Time Frame 12 month interval
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Alternate Day Fasting (ADF) Calorie Restriction (CR) Control
Hide 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
Overall Number of Participants Analyzed 34 35 31
Mean (Standard Error)
Unit of Measure: Percent change from baseline to month 12
-36  (13) -34  (12) 12  (16)
7.Secondary Outcome
Title Change in Plasma C-reactive Protein Concentrations
Hide Description Change in plasma C-reactive protein concentrations from baseline to month 12
Time Frame 12 month interval
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Alternate Day Fasting (ADF) Calorie Restriction (CR) Control
Hide 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
Overall Number of Participants Analyzed 34 35 31
Mean (Standard Error)
Unit of Measure: 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
Hide Description Change in plasma Homocysteine concentrations from baseline to month 12
Time Frame 12 month interval
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Alternate Day Fasting (ADF) Calorie Restriction (CR) Control
Hide 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
Overall Number of Participants Analyzed 34 35 31
Mean (Standard Error)
Unit of Measure: Percent change from baseline to month 12
0.2  (4.3) -1.2  (3.2) -2.6  (3.3)
Time Frame 12 months
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Alternate Day Fasting (ADF) Calorie Restriction (CR) Control
Hide 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 (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/34 (0.00%)   0/35 (0.00%)   0/31 (0.00%) 
Hide Serious Adverse Events
Alternate Day Fasting (ADF) Calorie Restriction (CR) Control
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/34 (0.00%)   0/35 (0.00%)   0/31 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Alternate Day Fasting (ADF) Calorie Restriction (CR) Control
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/34 (0.00%)   0/35 (0.00%)   0/31 (0.00%) 
  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.
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.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Krista Varady, PhD, Associate Professor
Organization: University of Illinois Chicago
Phone: 3129967897
EMail: varady@uic.edu
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Krista Varady, University of Illinois at Chicago
ClinicalTrials.gov Identifier: NCT00960505    
Other Study ID Numbers: 2010-0118
R01HL106228 ( U.S. NIH Grant/Contract )
First Submitted: August 14, 2009
First Posted: August 17, 2009
Results First Submitted: May 22, 2017
Results First Posted: July 9, 2020
Last Update Posted: July 21, 2020