- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT04527952
The Fasting and Shifted Timing (FAST) of Eating Study (FAST)
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
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.
Studietype
Registrering (Faktiske)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiesteder
-
-
South Carolina
-
Columbia, South Carolina, Forente stater, 29208
- University of South Carolina
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
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
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Ikke-randomisert
- Intervensjonsmodell: Crossover-oppdrag
- Masking: Enkelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: 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
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Weight loss-week 1
Tidsramme: 1 week
|
We will assess weight loss via self-report after 1 week on diet #1
|
1 week
|
|
Weight loss- week 2
Tidsramme: 1 week
|
We will assess weight loss via self-report after 1 week on diet #2
|
1 week
|
|
Weight loss- week 3
Tidsramme: 1 week
|
We will assess weight loss via self-report after 1 week on diet #3
|
1 week
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Energy intake-week 1
Tidsramme: 6 weeks
|
Energy (kcal) intake will be assessed after 1 week on diet #1
|
6 weeks
|
|
Energy intake- week 2
Tidsramme: 6 weeks
|
Energy (kcal) intake will be assessed after 1 week on diet #2
|
6 weeks
|
|
Energy intake- week 3
Tidsramme: 6 weeks
|
Energy (kcal) intake will be assessed after 1 week on diet #3
|
6 weeks
|
Samarbeidspartnere og etterforskere
Sponsor
Etterforskere
- Hovedetterforsker: Gabrielle Turner-McGrievy, University of South Carolina
Publikasjoner og nyttige lenker
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- Pro00089911
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
Legemiddel- og utstyrsinformasjon, studiedokumenter
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