- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT04527952
The Fasting and Shifted Timing (FAST) of Eating Study (FAST)
Studieöversikt
Status
Betingelser
Intervention / Behandling
Detaljerad beskrivning
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.
Studietyp
Inskrivning (Faktisk)
Fas
- Inte tillämpbar
Kontakter och platser
Studieorter
-
-
South Carolina
-
Columbia, South Carolina, Förenta staterna, 29208
- University of South Carolina
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
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.
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Icke-randomiserad
- Interventionsmodell: Crossover tilldelning
- Maskning: Enda
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: Time-restricted feeding (TRF)
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.
|
Participants will receive handouts via email about how to follow each diet
|
|
Aktiv komparator: Intermittent fasting (IF)
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.
|
Participants will receive handouts via email about how to follow each diet
|
|
Aktiv komparator: Alternate day fasting (ADF)
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.
|
Participants will receive handouts via email about how to follow each diet
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Weight loss-week 1
Tidsram: 1 week
|
We will assess weight loss via self-report after 1 week on diet #1
|
1 week
|
|
Weight loss- week 2
Tidsram: 1 week
|
We will assess weight loss via self-report after 1 week on diet #2
|
1 week
|
|
Weight loss- week 3
Tidsram: 1 week
|
We will assess weight loss via self-report after 1 week on diet #3
|
1 week
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Energy intake-week 1
Tidsram: 6 weeks
|
Energy (kcal) intake will be assessed after 1 week on diet #1
|
6 weeks
|
|
Energy intake- week 2
Tidsram: 6 weeks
|
Energy (kcal) intake will be assessed after 1 week on diet #2
|
6 weeks
|
|
Energy intake- week 3
Tidsram: 6 weeks
|
Energy (kcal) intake will be assessed after 1 week on diet #3
|
6 weeks
|
Samarbetspartners och utredare
Sponsor
Utredare
- Huvudutredare: Gabrielle Turner-McGrievy, University of South Carolina
Publikationer och användbara länkar
Studieavstämningsdatum
Studera stora datum
Studiestart (Faktisk)
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- Pro00089911
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
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