Alternate Day Fasting Combined With a High Protein Background Diet

January 6, 2021 updated by: Krista Varady, University of Illinois at Chicago

Alternate Day Fasting Combined With a High Protein Background Diet for Weight Loss and Weight Maintenance in Adults With Obesity

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

52

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Illinois
      • Chicago, Illinois, United States, 60622
        • University of Illinois, Chicago

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Body weight
Time Frame: Change from baseline to week 24
Measured by digital scale
Change from baseline to week 24

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Triglycerides
Time Frame: Change from baseline to week 24
Measured by ELISA
Change from baseline to week 24
Glucose
Time Frame: Change from baseline to week 24
Measured by glucometer
Change from baseline to week 24
Insulin
Time Frame: Change from baseline to week 24
Measured ELISA
Change from baseline to week 24
Insulin resistance
Time Frame: Change from baseline to week 24
Measured as HOMA-IR
Change from baseline to week 24
Sleep quality
Time Frame: Change from baseline to week 24
Measured by Pittsburgh Sleep Quality Index (PSQI), total score of 0-21. A PSQI
Change from baseline to week 24
Insomnia severity
Time Frame: 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).
Change from baseline to week 24
Sleep apnea
Time Frame: Change from baseline to week 24
Measured by Berlin Questionnaire, measures the presence or absence of sleep apnea
Change from baseline to week 24
Appetite
Time Frame: Change from baseline to week 24
Measured by Visual analog scale (VAS). Scored from 0-100. Higher score means higher appetite.
Change from baseline to week 24

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Illinois at Chicago

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2018

Primary Completion (Actual)

March 1, 2019

Study Completion (Actual)

March 1, 2019

Study Registration Dates

First Submitted

April 24, 2018

First Submitted That Met QC Criteria

May 4, 2018

First Posted (Actual)

May 17, 2018

Study Record Updates

Last Update Posted (Actual)

January 8, 2021

Last Update Submitted That Met QC Criteria

January 6, 2021

Last Verified

January 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2017-1363

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Subscribe