Alternate Day Fasting Combined With a High Protein Background Diet

• Sponsor: University of Illinois at Chicago (Other)
• Overall Status: Completed
• CT.gov ID: NCT03528317
• Collaborator: (none)
• Enrollment: 52
• Location: 1
• Arm: 1
• Actual Duration (Months): 9
• Patients Per Site Per Month: 5.8

Study Details

Study Description

Brief Summary

The aims of this study are as follows: AIM 1: To examine the weight loss and weight maintenance efficacy of an alternate day fasting-high protein (ADF-HP) diet; AIM 2: To examine the effects of an ADF-HP diet on metabolic disease risk factors (plasma lipids, fasting glucose, fasting insulin, insulin resistance).

Condition or Disease	Intervention/Treatment	Phase
Obesity	Other: Alternate day fasting	N/A

Detailed Description

Background: Accumulating evidence suggests that alternate day fasting (ADF) is an effective diet strategy to help individuals with obesity lose weight and lower metabolic disease risk. ADF regimens include a "feast day" where food is consumed ad-libitum over 24 h, alternated with a "fast day" where intake is limited to ~600 kcal over 24 h. What has yet to be elucidated is whether consuming a high protein diet (as meal replacements) during ADF is effective for weight loss, weight maintenance, and metabolic disease risk reduction in individuals with obesity.

Objective: The aims of this study are as follows: AIM 1: To examine the weight loss and weight maintenance efficacy of an alternate day fasting-high protein (ADF-HP) diet; AIM 2: To examine the effects of an ADF-HP diet on metabolic disease risk factors (plasma lipids, fasting glucose, fasting insulin, insulin resistance).

Methods: A 24-week, single-center, longitudinal pilot study will be conducted to test the study objectives. The trial will be divided into 2 consecutive intervention periods: (1) 12-week weight loss period, and (2) 12-week weight maintenance period. Subjects with obesity will participate in an ADF-HP: alternate day fasting-high protein diet: 600 kcal "fast day" alternated with ad libitum "feast day", 35% kcal as protein. ADF-HP subjects will consume the Optifast HP Shake Mix (Nestle) on each day of the trial. Body weight, insulin, glucose, and insulin resistance, will be measured at baseline, week 12, and week 24.

Significance: These findings may show that alternate day fasting combined with high protein meal replacements may be implemented as an effective diet therapy to help individuals with obesity lose weight, maintain weight loss, and sustain reductions in metabolic disease risk.

Study Design

• Study Type: Interventional
• Actual Enrollment: 52 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Prevention
• Official Title: Alternate Day Fasting Combined With a High Protein Background Diet for Weight Loss and Weight Maintenance in Adults With Obesity
• Actual Study Start Date: Jun 1, 2018
• Actual Primary Completion Date: Mar 1, 2019
• Actual Study Completion Date: Mar 1, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Alternate day fasting Alternate day fasting with a high protein diet	Other: Alternate day fasting; Alternate day fasting with a high protein diet

Outcome Measures

Primary Outcome Measures

1. Body weight [Change from baseline to week 24]

   Measured by digital scale

Secondary Outcome Measures

1. Triglycerides [Change from baseline to week 24]

   Measured by ELISA

2. Glucose [Change from baseline to week 24]

   Measured by glucometer

3. Insulin [Change from baseline to week 24]

   Measured ELISA

4. Insulin resistance [Change from baseline to week 24]

   Measured as HOMA-IR

5. Sleep quality [Change from baseline to week 24]

   Measured by Pittsburgh Sleep Quality Index (PSQI), total score of 0-21. A PSQI

6. Insomnia severity [Change from baseline to week 24]

   Measured by Insomnia Severity Index (ISI), total score of 0-28. The total score for the ISI is interpreted as follows: no clinically significant insomnia (0-7), sub-threshold insomnia (8-14), moderate severity insomnia (15-21), and severe insomnia (22-28).

7. Sleep apnea [Change from baseline to week 24]

   Measured by Berlin Questionnaire, measures the presence or absence of sleep apnea

8. Appetite [Change from baseline to week 24]

   Measured by Visual analog scale (VAS). Scored from 0-100. Higher score means higher appetite.

Eligibility Criteria

Criteria

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

Inclusion Criteria:

• Age between 18 to 65 years old

• BMI between 30.0 and 49.9 kg/m2

• Previously sedentary or lightly active

Exclusion Criteria:

• Diabetic

• History of binge eating disorder

• Taking weight loss-inducing medications

• Not weight stable for 3 months prior to the study (weight gain or loss > 4 kg)

• Perimenopausal or have an irregular menstrual cycle (menses that does not appear every 27-32 days)

• Pregnant or trying to become pregnant

• Night shift worker

• 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

Investigators

• Principal Investigator: Krista Varady, University of Illinois Chicago (UIC)

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Krista Varady, Professor of Nutrition, University of Illinois at Chicago
• ClinicalTrials.gov Identifier: NCT03528317
• Other Study ID Numbers: 2017-1363
• First Posted: May 17, 2018
• Last Update Posted: Jan 8, 2021
• Last Verified: Jan 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Obesity

Study Results

No Results Posted as of Jan 8, 2021