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Auswirkungen der Diätreihenfolge von fettarmen vs. kohlenhydratarmen Diäten auf die Veränderung des Körperfetts

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....

Studienübersicht

Status

Rekrutierung

Bedingungen

Intervention / Behandlung

Detaillierte Beschreibung

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.

Studientyp

Interventionell

Einschreibung (Geschätzt)

42

Phase

  • Unzutreffend

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienkontakt

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

Studieren Sie die Kontaktsicherung

Studienorte

    • Maryland
      • Bethesda, Maryland, Vereinigte Staaten, 20892
        • Rekrutierung
        • National Institutes of Health Clinical Center
        • Kontakt:

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

18 Jahre bis 50 Jahre (Erwachsene)

Akzeptiert gesunde Freiwillige

Nein

Studienberechtigte Geschlechter

Alle

Beschreibung

  • 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

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Grundlegende Wissenschaft
  • Zuteilung: Zufällig
  • Interventionsmodell: Crossover-Aufgabe
  • Maskierung: Single

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Experimental: 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

Experimental: 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

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Change in total fat mass
Zeitfenster: 8 weeks

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

8 weeks

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Rate of body weight change from baseline to week 8
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

Ermittler

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

Publikationen und hilfreiche Links

Die Bereitstellung dieser Publikationen erfolgt freiwillig durch die für die Eingabe von Informationen über die Studie verantwortliche Person. Diese können sich auf alles beziehen, was mit dem Studium zu tun hat.

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Tatsächlich)

28. August 2024

Primärer Abschluss (Geschätzt)

30. November 2029

Studienabschluss (Geschätzt)

30. November 2029

Studienanmeldedaten

Zuerst eingereicht

21. März 2024

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

21. März 2024

Zuerst gepostet (Tatsächlich)

22. März 2024

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

2. November 2026

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

30. Oktober 2026

Zuletzt verifiziert

29. Oktober 2026

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Andere Studien-ID-Nummern

  • 10001680
  • 001680-DK

Plan für individuelle Teilnehmerdaten (IPD)

Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?

JA

Beschreibung des IPD-Plans

Body fat and body weight data

IPD-Sharing-Zeitrahmen

Upon publication in peer reviewed journal

IPD-Sharing-Zugriffskriterien

Open, general access

Art der unterstützenden IPD-Freigabeinformationen

  • STUDIENPROTOKOLL
  • ANALYTIC_CODE

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Nein

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .