The Fasting and Shifted Timing (FAST) of Eating Study

Overweight and Obesity Clinical Trial

— FAST  

Official title:

The Fasting and Shifted Timing (FAST) of Eating Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04527952
• Other study ID #: Pro00089911
• Status: Completed
• Phase: N/A
• Start date: June 19, 2019
• Est. completion date: August 1, 2020

Study information

• Verified date: April 2021
• Source: University of South Carolina
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 28
• Est. completion date: August 1, 2020
• Est. primary completion date: July 31, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Overweight
• Overweight and Obesity

Intervention

Behavioral:
• Online handouts describing how to follow each diet for 1 week each
Participants will receive handouts via email about how to follow each diet

Locations

Country	Name	City	State
United States	University of South Carolina	Columbia	South Carolina

Sponsors (1)

Lead Sponsor	Collaborator
University of South Carolina

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Weight loss-week 1	We will assess weight loss via self-report after 1 week on diet #1	1 week
Primary	Weight loss- week 2	We will assess weight loss via self-report after 1 week on diet #2	1 week
Primary	Weight loss- week 3	We will assess weight loss via self-report after 1 week on diet #3	1 week
Secondary	Energy intake-week 1	Energy (kcal) intake will be assessed after 1 week on diet #1	6 weeks
Secondary	Energy intake- week 2	Energy (kcal) intake will be assessed after 1 week on diet #2	6 weeks
Secondary	Energy intake- week 3	Energy (kcal) intake will be assessed after 1 week on diet #3	6 weeks