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Completed

NCT Number: NCT04527952

The Fasting and Shifted Timing (FAST) of Eating Study

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of South Carolina

Columbia, South Carolina, 29208, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

Behavioral

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

Primary outcomes

  1. Weight loss-week 1

    Time frame: 1 week

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

  2. Weight loss- week 2

    Time frame: 1 week

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

  3. Weight loss- week 3

    Time frame: 1 week

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

Secondary outcomes

  1. Energy intake-week 1

    Time frame: 6 weeks

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

  2. Energy intake- week 2

    Time frame: 6 weeks

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

  3. Energy intake- week 3

    Time frame: 6 weeks

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

Sponsors and collaborators

Lead sponsor

University of South Carolina

Other

Registry information

Acronym: FAST

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Aug 27, 2020
Registry last updated
Apr 28, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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