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Kostholdsrekkefølge Effekter av lavfett- vs. lavkarbodietter på kroppsfettendring

Background:

In a previous study, participants were lived at the NIH and randomly received either a low-fat or a low-carbohydrate diet for 2 weeks and then switched to the other diet for 2 more weeks. Participants who received the low-carbohydrate diet first lost more body fat at the end of the study than those who received the low-fat diet first. Researchers want to see if they can repeat that result in a longer weight loss study when participants live at home.

Objective:

To test the effects of diet order in people receiving either a low-fat or low-carbohydrate diet first for 4 weeks and then immediately switched to the other diet for another 4 weeks.

Eligibility:

Adults aged 19 to 50 years with a body mass index of 25 or more.

Design:

Participants will complete the study at their homes, but there will be 3 required visits to the NIH. Participants will drink a special type of water 2 weeks before the baseline NIH visit and collect urine samples at home to measure how many calories they burn. Before the diets begin, participants will visit the NIH for baseline testing when they will have a metabolism test while relaxing in a bed with a plastic hood over their head to collect the air they breathe out. They will have scans to measure their bone density and how much muscle and body fat they have. They will give stool, blood, and urine samples.

Participants will be asked to eat a specific diet for 4 weeks followed by a different diet for 4 weeks. All meals will be delivered to the participants' homes. They will eat only the foods delivered.

Participants will weigh themselves daily. They will wear a monitor to track their physical activity and a sensor to measure their glucose levels. They will prick their finger each morning to test a drop of blood for ketones. Participants will meet virtually as a group with the study team weekly. Participants will have two more NIH visits towards the end of each diet period....

Studieoversikt

Status

Rekruttering

Detaljert beskrivelse

Study Description:

This is an 8-week crossover outpatient feeding trial of a low carbohydrate versus a low-fat diet, each provided for 4 weeks in random order with no washout period, in adult volunteers with overweight or obesity.

Objectives:

Primary Objectives: To determine the effect of diet order on the mean total fat mass change in subjects randomized to receive either a low carbohydrate followed by a low fat diet or the reverse order, with each diet lasting for 4 weeks.

Secondary Objectives: To determine the effect of diet order on the mean rate of body weight change in subjects randomized to receive either a low carbohydrate followed by a low fat diet or the reverse order, with each diet lasting for 4 weeks and the rate of weight change is measured during the last 2 weeks of each diet. To determine the effect of diet order on mean total body weight change in subjects randomized to receive either a low carbohydrate followed by a low fat diet or the reverse order, with each diet lasting for 4 weeks.

Endpoints:

Primary Endpoint: Mean total fat mass change measured by dual energy X-ray absorptiometry at baseline and week 8.

Secondary Endpoints: Mean rate of weight change by linear mixed modeling of daily weight measurements. Mean total body weight change measured between baseline and week 8.

Studietype

Intervensjonell

Registrering (Antatt)

42

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

  • Navn: Nan Zhai, C.R.N.P.
  • Telefonnummer: (301) 827-3324
  • E-post: nan.zhai@nih.gov

Studer Kontakt Backup

Studiesteder

    • Maryland
      • Bethesda, Maryland, Forente stater, 20892
        • Rekruttering
        • National Institutes of Health Clinical Center
        • Ta kontakt med:

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år til 50 år (Voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

  • INCLUSION CRITERIA:

In order to be eligible to participate in this study, an individual must meet all of the following criteria:

  1. Stated willingness to comply with all study procedures and availability for the duration of the study
  2. Adults aged 18-50 years
  3. Weight stable (< +/- 5% over past 6 months) as determined by volunteer report
  4. Body mass index (BMI) >= 25 kg/m^2
  5. Agreement to adhere to Lifestyle Considerations throughout the study duration

EXCLUSION CRITERIA:

  1. Subjects with cardiac pacemakers or other implants that may be affected by or affect the DXA measurements
  2. Inadequate access to equipment required for the study (e.g., too little refrigerator storage space or a microwave oven that is too small) as determined by discretion of PI and/or study team
  3. Evidence of diseases or conditions that may influence appetite (e.g., cancer, diabetes, alterations of smell or taste post COVID-19), diseases or conditions that affect the immune system, or other conditions at the discretion of the PI and/or study team
  4. Taking prescription medications or other drugs that may influence metabolism (including but not limited to diet/weight-loss medication, some psychiatric medications, or other medications at the discretion of the PI and/or study team)
  5. People unlikely to adhere to a relatively consistent daily and weekly routine and avoid travel during their participation in the study. For example, people with occupations such as pilots, flight attendants, or frequently travel for work or pleasure.
  6. People unlikely to abstain from off study food or supplements that may impact metabolism or appetite at the discretion of the study team
  7. Positive pregnancy test or lactating as determined by volunteer report (women only)
  8. Inability or unwillingness to use birth control between screening and completion of the study (women only)
  9. Symptoms or signs of perimenopause or menopause by volunteer report (women only)
  10. Regular vigorous exercise >150 min per week as determined by volunteer report
  11. Alcohol consumption > 3 drinks per day as determined by volunteer report
  12. Regular use of tobacco (smoking, chewing, or vaping), nicotine replacement therapy, or illicit drugs over past 6 months as determined by volunteer report. Subjects may also be excluded based on a urine drug test.
  13. Psychological conditions as determined by DSM-5 Self-rated Level 1 Cross-cutting Symptom Measure such as (but not limited to) eating disorders, depression, bipolar disorders, that would be incompatible with safe and successful participation in this study, as determined by investigators
  14. Volunteers with strict dietary concerns (e.g. vegetarian or kosher diet, food allergies) or a reported dislike of a significant fraction of the study foods
  15. Volunteers unwilling or unable to give informed consent
  16. Non-English speakers due to unavailability of required questionnaires in other languages
  17. Resting Energy Expenditure test result within 10% of the 2500 calorie requirement at rest

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Grunnvitenskap
  • Tildeling: Randomisert
  • Intervensjonsmodell: Crossover-oppdrag
  • Masking: Enkelt

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: low-carbohydrate diet then low-fat diet

A low-carbohydrate followed by low-fat diet, each lasting for 4 weeks in adults with overweight or obesity

Consisting of 15 percent protein, 75 percent fat, and 10 percent carbohydrate

Consisting of 15 percent protein, 10 percent fat, and 75 percent carbohydrate

Eksperimentell: low-fat diet then low-carbohydrate diet

A low-fat followed by low-carbohydrate diet, each lasting for 4 weeks in adults with overweight or obesity

Consisting of 15 percent protein, 75 percent fat, and 10 percent carbohydrate

Consisting of 15 percent protein, 10 percent fat, and 75 percent carbohydrate

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Change in total fat mass
Tidsramme: 8 weeks

Change in total fat mass (kg) as measured by dual energy X-ray absorptiometry (DXA) from baseline to week 8

8 weeks

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Rate of body weight change from baseline to week 8
Tidsramme: 8 weeks

Rate of body weight change (kg/d) from baseline to week 8

8 weeks
Rate of body weight change during low-carbohydrate diet
Tidsramme: Last 2 weeks of low-carbohydrate diet period

Rate of body weight change (kg/d) during the last two weeks of the low-carbohydrate diet

Last 2 weeks of low-carbohydrate diet period
Rate of body weight change during low-fat diet
Tidsramme: Last 2 weeks of low-fat diet period

Rate of body weight change (kg/d) during the last two weeks of the low-fat diet

Last 2 weeks of low-fat diet period

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Etterforskere

  • Hovedetterforsker: Valerie L Darcey, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

28. august 2024

Primær fullføring (Antatt)

30. november 2029

Studiet fullført (Antatt)

30. november 2029

Datoer for studieregistrering

Først innsendt

21. mars 2024

Først innsendt som oppfylte QC-kriteriene

21. mars 2024

Først lagt ut (Faktiske)

22. mars 2024

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

2. november 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

30. oktober 2026

Sist bekreftet

29. oktober 2026

Mer informasjon

Begreper knyttet til denne studien

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

JA

IPD-planbeskrivelse

Body fat and body weight data

IPD-delingstidsramme

Upon publication in peer reviewed journal

Tilgangskriterier for IPD-deling

Open, general access

IPD-deling Støtteinformasjonstype

  • STUDY_PROTOCOL
  • ANALYTIC_CODE

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

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