Overweight and ObesityFASTNCT04527952
The Fasting and Shifted Timing (FAST) of Eating Study
A study testing Online handouts describing how to follow each diet for 1 week each in people with Overweight and Obesity, run by University of South Carolina at 1 site in United States.
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). Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Overweight and Obesity
- What is being tested?
- Online handouts describing how to follow each diet for 1 week each
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Jun 2019to 1 Aug 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of South Carolina
Columbia, South Carolina, 29208
About this 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.
Read the 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.
- Conditions
- Overweight and Obesity
- Being tested
- Online handouts describing how to follow each diet for 1 week each
- Keywords
- fasting
- Medical subject headings
- Overweight, Obesity, Fasting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Online handouts describing how to follow each diet for 1 week eachBehavioural
Participants will receive handouts via email about how to follow each diet
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: Behavioral: Online handouts describing how to follow each diet for 1 week each |
What is being measured
The primary outcome is the main question the study is designed to answer.
Weight loss-week 1
We will assess weight loss via self-report after 1 week on diet #1
Measured: 1 week
Weight loss- week 2
We will assess weight loss via self-report after 1 week on diet #2
Measured: 1 week
Weight loss- week 3
We will assess weight loss via self-report after 1 week on diet #3
Measured: 1 week
Secondary outcomes (3)
Energy intake-week 1
Energy (kcal) intake will be assessed after 1 week on diet #1
Measured: 6 weeks
Energy intake- week 2
Energy (kcal) intake will be assessed after 1 week on diet #2
Measured: 6 weeks
Energy intake- week 3
Energy (kcal) intake will be assessed after 1 week on diet #3
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2020
- Study start19 Jun 2019
- Primary completion31 Jul 2020
- Study completion1 Aug 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Overweight and ObesityStudies of the same condition, open and under way.
- More trials run by University of South CarolinaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of South Carolina
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Brie Turner-McGrievy, University of South Carolina
- Investigators
- Gabrielle Turner-McGrievy, Principal investigator, University of South Carolina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04527952
- Sponsor's protocol ID
- Pro00089911
- Acronym
- FAST
- Status last verified
- Apr 2021
- First submitted
- 19 Aug 2020
- Last updated
- 28 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 35716852
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Fasting and Shifted Timing (FAST) of Eating Study
- ClinicalTrials.gov ID
- NCT04527952
- Acronym / sponsor ID
- FAST / Pro00089911
- Conditions
- Overweight and Obesity
- Keywords
- fasting
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- University of South CarolinaUniversity, hospital or other
- Study start
- 19 Jun 2019 (actual)
- Primary completion
- 31 Jul 2020 (actual)
- Study completion
- 1 Aug 2020 (actual)
- First posted
- 27 Aug 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Time-restricted feeding (TRF) | Experimental | Behavioral: Online handouts describing how to follow each diet for 1 week eachParticipants 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. |
| Intermittent fasting (IF) | Active comparator | Behavioral: Online handouts describing how to follow each diet for 1 week eachThis 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. |
| Alternate day fasting (ADF) | Active comparator | Behavioral: Online handouts describing how to follow each diet for 1 week eachThis 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Online handouts describing how to follow each diet for 1 week eachParticipants will receive handouts via email about how to follow each diet | Behavioural | Alternate day fasting (ADF), Intermittent fasting (IF), Time-restricted feeding (TRF) |
Primary outcome
Weight loss-week 1
Time frame: 1 week
We will assess weight loss via self-report after 1 week on diet #1
Weight loss- week 2
Time frame: 1 week
We will assess weight loss via self-report after 1 week on diet #2
Weight loss- week 3
Time frame: 1 week
We will assess weight loss via self-report after 1 week on diet #3
3 secondary outcomes
Energy intake-week 1
Time frame: 6 weeks
Energy intake- week 2
Time frame: 6 weeks
Energy intake- week 3
Time frame: 6 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2021.
- Derived from this study: PubMed 35716852Turner-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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gabrielle Turner-McGrievy principal investigator
University of South Carolina
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Online handouts describing how to follow each diet for 1 week each in people with Overweight and Obesity, run by University of South Carolina at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Weight loss-week 1 (time frame: 1 week). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04527952, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Apr 2021.