Trial Outcomes & Findings for Alternate Day Fasting for Weight Loss, Weight Maintenance and Cardio-protection (NCT NCT00960505)

NCT ID: NCT00960505

Last Updated: 2020-07-21

Results Overview

Change in body weight from baseline to month 12

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 100 participants
• Primary outcome timeframe: Baseline to month 12
• Results posted on: 2020-07-21

Participant Flow

Participant milestones

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

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	Alternate Day Fasting (ADF) n=34 Participants Fast day diet: 25% energy intake, Feast day diet: Ad libitum energy intake (alternating days) Alternate day fasting	Calorie Restriction (CR) n=35 Participants 75% energy intake every day Calorie restriction	Control n=31 Participants Usual diet Control diet	Total n=100 Participants Total of all reporting groups
Age, Continuous	44 Years STANDARD_DEVIATION 10 • n=5 Participants	43 Years STANDARD_DEVIATION 12 • n=7 Participants	44 Years STANDARD_DEVIATION 11 • n=5 Participants	44 Years STANDARD_DEVIATION 11 • n=4 Participants
Sex: Female, Male Female	30 Participants n=5 Participants	29 Participants n=7 Participants	27 Participants n=5 Participants	86 Participants n=4 Participants
Sex: Female, Male Male	4 Participants n=5 Participants	6 Participants n=7 Participants	4 Participants n=5 Participants	14 Participants n=4 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	2 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	3 Participants n=4 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	32 Participants n=5 Participants	34 Participants n=7 Participants	31 Participants n=5 Participants	97 Participants n=4 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	2 Participants n=4 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Black or African American	22 Participants n=5 Participants	21 Participants n=7 Participants	20 Participants n=5 Participants	63 Participants n=4 Participants
Race (NIH/OMB) White	11 Participants n=5 Participants	13 Participants n=7 Participants	11 Participants n=5 Participants	35 Participants n=4 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants

PRIMARY outcome

Timeframe: Baseline to month 12

Change in body weight from baseline to month 12

Outcome measures

Measure	Alternate Day Fasting (ADF) n=34 Participants Fast day diet: 25% energy intake, Feast day diet: Ad libitum energy intake (alternating days) Alternate day fasting	Calorie Restriction (CR) n=35 Participants 75% energy intake every day Calorie restriction	Control n=31 Participants Usual diet
Body Weight	-4.6 Percent change at month 12 Standard Error 0.9	-4.5 Percent change at month 12 Standard Error 0.9	0.3 Percent change at month 12 Standard Error 0.6

SECONDARY outcome

Timeframe: 12 month interval

Change in HDL cholesterol from baseline to month 12

Outcome measures

Measure	Alternate Day Fasting (ADF) n=34 Participants Fast day diet: 25% energy intake, Feast day diet: Ad libitum energy intake (alternating days) Alternate day fasting	Calorie Restriction (CR) n=35 Participants 75% energy intake every day Calorie restriction	Control n=31 Participants Usual diet
Change in HDL Cholesterol	4.6 Percent change from baseline to month 12 Standard Error 3.1	-0.5 Percent change from baseline to month 12 Standard Error 3.1	-3.4 Percent change from baseline to month 12 Standard Error 3.9

SECONDARY outcome

Timeframe: 12 month interval

Change in systolic blood pressure from baseline to month 12

Outcome measures

Measure	Alternate Day Fasting (ADF) n=34 Participants Fast day diet: 25% energy intake, Feast day diet: Ad libitum energy intake (alternating days) Alternate day fasting	Calorie Restriction (CR) n=35 Participants 75% energy intake every day Calorie restriction	Control n=31 Participants Usual diet
Change in Systolic Blood Pressure	-3.5 Percent change from baseline to month 12 Standard Error 2.3	-2.9 Percent change from baseline to month 12 Standard Error 2.0	-2.6 Percent change from baseline to month 12 Standard Error 4.0

SECONDARY outcome

Timeframe: 12 month interval

Change in fasting glucose from baseline to month 12

Outcome measures

Measure	Alternate Day Fasting (ADF) n=34 Participants Fast day diet: 25% energy intake, Feast day diet: Ad libitum energy intake (alternating days) Alternate day fasting	Calorie Restriction (CR) n=35 Participants 75% energy intake every day Calorie restriction	Control n=31 Participants Usual diet
Change in Fasting Glucose	4.0 Percent change from baseline to month 12 Standard Error 2.0	-1.9 Percent change from baseline to month 12 Standard Error 3.3	10.7 Percent change from baseline to month 12 Standard Error 3.4

SECONDARY outcome

Timeframe: 12 month interval

Change in fasting insulin from baseline to month 12

Outcome measures

Measure	Alternate Day Fasting (ADF) n=34 Participants Fast day diet: 25% energy intake, Feast day diet: Ad libitum energy intake (alternating days) Alternate day fasting	Calorie Restriction (CR) n=35 Participants 75% energy intake every day Calorie restriction	Control n=31 Participants Usual diet
Change in Fasting Insulin	-35 Percent change from baseline to month 12 Standard Error 11	-28 Percent change from baseline to month 12 Standard Error 9	-2.5 Percent change from baseline to month 12 Standard Error 13

SECONDARY outcome

Timeframe: 12 month interval

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

Outcome measures

Measure	Alternate Day Fasting (ADF) n=34 Participants Fast day diet: 25% energy intake, Feast day diet: Ad libitum energy intake (alternating days) Alternate day fasting	Calorie Restriction (CR) n=35 Participants 75% energy intake every day Calorie restriction	Control n=31 Participants Usual diet
Change in Insulin Resistance Measured by HOMA-IR	-36 Percent change from baseline to month 12 Standard Error 13	-34 Percent change from baseline to month 12 Standard Error 12	12 Percent change from baseline to month 12 Standard Error 16

SECONDARY outcome

Timeframe: 12 month interval

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

Outcome measures

Measure	Alternate Day Fasting (ADF) n=34 Participants Fast day diet: 25% energy intake, Feast day diet: Ad libitum energy intake (alternating days) Alternate day fasting	Calorie Restriction (CR) n=35 Participants 75% energy intake every day Calorie restriction	Control n=31 Participants Usual diet
Change in Plasma C-reactive Protein Concentrations	-13.9 Percent change from baseline to month 12 Standard Error 11.7	-6.2 Percent change from baseline to month 12 Standard Error 8.1	5.4 Percent change from baseline to month 12 Standard Error 16.8

SECONDARY outcome

Timeframe: 12 month interval

Change in plasma Homocysteine concentrations from baseline to month 12

Outcome measures

Measure	Alternate Day Fasting (ADF) n=34 Participants Fast day diet: 25% energy intake, Feast day diet: Ad libitum energy intake (alternating days) Alternate day fasting	Calorie Restriction (CR) n=35 Participants 75% energy intake every day Calorie restriction	Control n=31 Participants Usual diet
Change in Plasma Homocysteine Concentrations	0.2 Percent change from baseline to month 12 Standard Error 4.3	-1.2 Percent change from baseline to month 12 Standard Error 3.2	-2.6 Percent change from baseline to month 12 Standard Error 3.3

Adverse Events

Alternate Day Fasting (ADF)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Calorie Restriction (CR)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Control

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Krista Varady, PhD, Associate Professor

University of Illinois Chicago

Phone: 3129967897

Email: varady@uic.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place