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Effets de l'ordre alimentaire des régimes faibles en gras et faibles en glucides sur le changement de graisse corporelle

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....

Aperçu de l'étude

Statut

Recrutement

Les conditions

Description détaillée

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.

Type d'étude

Interventionnel

Inscription (Estimé)

42

Phase

  • N'est pas applicable

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Coordonnées de l'étude

  • Nom: Nan Zhai, C.R.N.P.
  • Numéro de téléphone: (301) 827-3324
  • E-mail: nan.zhai@nih.gov

Sauvegarde des contacts de l'étude

Lieux d'étude

    • Maryland
      • Bethesda, Maryland, États-Unis, 20892
        • Recrutement
        • National Institutes of Health Clinical Center
        • Contact:

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

18 ans à 50 ans (Adulte)

Accepte les volontaires sains

Non

Sexes éligibles pour l'étude

Tout

La description

  • 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

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: Science basique
  • Répartition: Randomisé
  • Modèle interventionnel: Affectation croisée
  • Masquage: Seul

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Expérimental: 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

Expérimental: 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

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Change in total fat mass
Délai: 8 weeks

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

8 weeks

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Rate of body weight change from baseline to week 8
Délai: 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
Délai: 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
Délai: 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

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Les enquêteurs

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

Publications et liens utiles

La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Réel)

28 août 2024

Achèvement primaire (Estimé)

30 novembre 2029

Achèvement de l'étude (Estimé)

30 novembre 2029

Dates d'inscription aux études

Première soumission

21 mars 2024

Première soumission répondant aux critères de contrôle qualité

21 mars 2024

Première publication (Réel)

22 mars 2024

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

2 novembre 2026

Dernière mise à jour soumise répondant aux critères de contrôle qualité

30 octobre 2026

Dernière vérification

29 octobre 2026

Plus d'information

Termes liés à cette étude

Plan pour les données individuelles des participants (IPD)

Prévoyez-vous de partager les données individuelles des participants (DPI) ?

OUI

Description du régime IPD

Body fat and body weight data

Délai de partage IPD

Upon publication in peer reviewed journal

Critères d'accès au partage IPD

Open, general access

Type d'informations de prise en charge du partage d'IPD

  • PROTOCOLE D'ÉTUDE
  • ANALYTIC_CODE

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Non

Étudie un produit d'appareil réglementé par la FDA américaine

Non

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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