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

Primary Purpose

Overweight and Obesity

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Online handouts describing how to follow each diet for 1 week each
Sponsored by
University of South Carolina
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Overweight and Obesity focused on measuring fasting

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • University of South Carolina

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Active Comparator

Arm Label

Time-restricted feeding (TRF)

Intermittent fasting (IF)

Alternate day fasting (ADF)

Arm Description

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.

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.

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.

Outcomes

Primary Outcome Measures

Weight loss-week 1
We will assess weight loss via self-report after 1 week on diet #1
Weight loss- week 2
We will assess weight loss via self-report after 1 week on diet #2
Weight loss- week 3
We will assess weight loss via self-report after 1 week on diet #3

Secondary Outcome Measures

Energy intake-week 1
Energy (kcal) intake will be assessed after 1 week on diet #1
Energy intake- week 2
Energy (kcal) intake will be assessed after 1 week on diet #2
Energy intake- week 3
Energy (kcal) intake will be assessed after 1 week on diet #3

Full Information

First Posted
August 19, 2020
Last Updated
April 26, 2021
Sponsor
University of South Carolina
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1. Study Identification

Unique Protocol Identification Number
NCT04527952
Brief Title
The Fasting and Shifted Timing (FAST) of Eating Study
Acronym
FAST
Official Title
The Fasting and Shifted Timing (FAST) of Eating Study
Study Type
Interventional

2. Study Status

Record Verification Date
April 2021
Overall Recruitment Status
Completed
Study Start Date
June 19, 2019 (Actual)
Primary Completion Date
July 31, 2020 (Actual)
Study Completion Date
August 1, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of South Carolina

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Overweight and Obesity
Keywords
fasting

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Outcomes Assessor
Allocation
Non-Randomized
Enrollment
28 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Time-restricted feeding (TRF)
Arm Type
Experimental
Arm Description
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.
Arm Title
Intermittent fasting (IF)
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Alternate day fasting (ADF)
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Online handouts describing how to follow each diet for 1 week each
Intervention Description
Participants will receive handouts via email about how to follow each diet
Primary Outcome Measure Information:
Title
Weight loss-week 1
Description
We will assess weight loss via self-report after 1 week on diet #1
Time Frame
1 week
Title
Weight loss- week 2
Description
We will assess weight loss via self-report after 1 week on diet #2
Time Frame
1 week
Title
Weight loss- week 3
Description
We will assess weight loss via self-report after 1 week on diet #3
Time Frame
1 week
Secondary Outcome Measure Information:
Title
Energy intake-week 1
Description
Energy (kcal) intake will be assessed after 1 week on diet #1
Time Frame
6 weeks
Title
Energy intake- week 2
Description
Energy (kcal) intake will be assessed after 1 week on diet #2
Time Frame
6 weeks
Title
Energy intake- week 3
Description
Energy (kcal) intake will be assessed after 1 week on diet #3
Time Frame
6 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gabrielle Turner-McGrievy
Organizational Affiliation
University of South Carolina
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of South Carolina
City
Columbia
State/Province
South Carolina
ZIP/Postal Code
29208
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
35716852
Citation
Turner-McGrievy GM, Wirth MD, Bernhart JA, Aydin H. The Fasting and Shifted Timing (FAST) of Eating Study: A pilot feasibility randomized crossover intervention assessing the acceptability of three different fasting diet approaches. Appetite. 2022 Sep 1;176:106135. doi: 10.1016/j.appet.2022.106135. Epub 2022 Jun 16.
Results Reference
derived

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The Fasting and Shifted Timing (FAST) of Eating Study

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