NCT04527952

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
28

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2019

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 19, 2019

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2020

Completed
1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2020

Completed
18 days until next milestone

First Submitted

Initial submission to the registry

August 19, 2020

Completed
8 days until next milestone

First Posted

Study publicly available on registry

August 27, 2020

Completed
Last Updated

April 28, 2021

Status Verified

April 1, 2021

Enrollment Period

1.1 years

First QC Date

August 19, 2020

Last Update Submit

April 26, 2021

Conditions

Keywords

fasting

Outcome Measures

Primary Outcomes (3)

  • Weight loss-week 1

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

    1 week

  • Weight loss- week 2

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

    1 week

  • Weight loss- week 3

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

    1 week

Secondary Outcomes (3)

  • Energy intake-week 1

    6 weeks

  • Energy intake- week 2

    6 weeks

  • Energy intake- week 3

    6 weeks

Study Arms (3)

Time-restricted feeding (TRF)

EXPERIMENTAL

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.

Behavioral: Online handouts describing how to follow each diet for 1 week each

Intermittent fasting (IF)

ACTIVE COMPARATOR

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.

Behavioral: Online handouts describing how to follow each diet for 1 week each

Alternate day fasting (ADF)

ACTIVE COMPARATOR

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.

Behavioral: Online handouts describing how to follow each diet for 1 week each

Interventions

Participants will receive handouts via email about how to follow each diet

Alternate day fasting (ADF)Intermittent fasting (IF)Time-restricted feeding (TRF)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of South Carolina

Columbia, South Carolina, 29208, United States

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

OverweightObesityFasting

Condition Hierarchy (Ancestors)

OvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsFeeding BehaviorBehavior

Study Officials

  • Gabrielle Turner-McGrievy

    University of South Carolina

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

August 19, 2020

First Posted

August 27, 2020

Study Start

June 19, 2019

Primary Completion

July 31, 2020

Study Completion

August 1, 2020

Last Updated

April 28, 2021

Record last verified: 2021-04

Data Sharing

IPD Sharing
Will not share

Locations