The Fasting and Shifted Timing (FAST) of Eating Study (FAST)

April 26, 2021 updated by: Brie Turner-McGrievy, University of South Carolina
The aim of this study is to assess peoples' satisfaction with their diet based on adhering to three different meal-timing protocols for one week each: (1) Time-restricted feeding (TRF); (2) Intermittent fasting (IF); and (3) Alternate day fasting (ADF). The overall goal of this study is to determine if people would find it easy or difficult to follow these diet protocols for the purpose of weight management.

Study Overview

Detailed Description

Fasting and time-restricted feeding (TRF) have become increasingly popular in nutrition research due to the potential health benefits they may provide. Several animal studies, and more recently some human studies, have indicated regular meal-timing (i.e. eating mostly in the day) or fasting have been beneficial for controlling weight, blood pressure, cholesterol, glucose, and insulin sensitivity.

These types of eating patterns may offer the same "anti-aging" health benefits as traditional caloric restriction (i.e. consistent and routine adherence to a very low-calorie diet).While caloric restriction is considered the gold standard for weight management, weight regain often limits the long-term effectiveness of this approach. People often experience increases in hunger, which make it difficult to sustain this type of behavior.Therefore, researchers are turning to these dietary approaches as alternatives to low-calorie diets in an effort to obtain the same benefits, but with less burden on participants.

However, it is not clear if the adherence to these types of diet protocols are any better than a low-calorie diet. Would people be more satisfied with meal-timing or fasting over a traditional very low-calorie diet? That is the main research question of this study.

Study Type

Interventional

Enrollment (Actual)

28

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

    • South Carolina
      • Columbia, South Carolina, United States, 29208
        • University of South Carolina

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 and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Be 18 years or older.
  • Have a BMI between 25 - 49.9 kg/m2.
  • Have a scale at home, or some way of weighing yourself regularly, so that you can report your body weight to the research staff.
  • Be able to check emails regularly, because all of the surveys need to be completed online.

Exclusion Criteria:

  • NOT be already practicing any of these fasting approaches.
  • NOT currently diagnosed with diabetes.
  • NOT taking any appetite suppressants or prescription weight loss medications.
  • NOT planning on getting pregnant within the next 6 weeks.
  • Do NOT currently have any eating disorders.
  • Have NOT lost or gained a significant amount of weight (i.e. 10 pounds or more) within the last 6 months.

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: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Time-restricted feeding (TRF)
Participants will eat the majority of their calories in the day. More specifically participants will consume 70% of their total calories before 5 pm and the remaining 30% after 5 pm.
Participants will receive handouts via email about how to follow each diet
Active Comparator: Intermittent fasting (IF)
This involves eating all of one's meals within a specific time (e.g. 8 hours) frame and fasting for the remaining hours (16 hours) in a day.
Participants will receive handouts via email about how to follow each diet
Active Comparator: Alternate day fasting (ADF)
This involves complete fasting (i.e. no food or caloric containing beverages, only water consumption) for roughly an entire 36-hour period, followed by an ad libitum feeding day.
Participants will receive handouts via email about how to follow each diet

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Weight loss-week 1
Time Frame: 1 week
We will assess weight loss via self-report after 1 week on diet #1
1 week
Weight loss- week 2
Time Frame: 1 week
We will assess weight loss via self-report after 1 week on diet #2
1 week
Weight loss- week 3
Time Frame: 1 week
We will assess weight loss via self-report after 1 week on diet #3
1 week

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Energy intake-week 1
Time Frame: 6 weeks
Energy (kcal) intake will be assessed after 1 week on diet #1
6 weeks
Energy intake- week 2
Time Frame: 6 weeks
Energy (kcal) intake will be assessed after 1 week on diet #2
6 weeks
Energy intake- week 3
Time Frame: 6 weeks
Energy (kcal) intake will be assessed after 1 week on diet #3
6 weeks

Collaborators and Investigators

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

Investigators

  • Principal Investigator: Gabrielle Turner-McGrievy, University of South Carolina

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.

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 19, 2019

Primary Completion (Actual)

July 31, 2020

Study Completion (Actual)

August 1, 2020

Study Registration Dates

First Submitted

August 19, 2020

First Submitted That Met QC Criteria

August 21, 2020

First Posted (Actual)

August 27, 2020

Study Record Updates

Last Update Posted (Actual)

April 28, 2021

Last Update Submitted That Met QC Criteria

April 26, 2021

Last Verified

April 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Pro00089911

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.

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