Effects of Diet and Exercise Interventions on Cardiometabolic Risk Markers, Executive Function, and Intestinal Flora
21 septembre 2021 mis à jour par: Yanna Zhu, Sun Yat-sen University
Effects of Diet and Exercise Interventions on Cardiometabolic Risk Markers, Executive Function, and Intestinal Flora in Undergraduate Students: a Randomized Controlled Trial
The purpose of this study is to estimate the effects of diet and exercise interventions on body weight, cardiovascular metabolic markers, executive function, and intestinal flora among undergraduate students, as well as the underlying mechanisms.
Aperçu de l'étude
Statut
Recrutement
Les conditions
Intervention / Traitement
Description détaillée
In recent decades, unhealthy dietary patterns and insufficiency of physical activity have brought negative effects on human health, such as rapid increasing incidence of obesity, metabolic cardiovascular diseases, and mental disorders.
The first line of prevention and therapy for these diseases is proper diet and lifestyle interventions.
A series of studies conducted in vivo and vitro have shown that high-fiber diets and time-restricted eating present benefits in weight loss, reducing cardiovascular disease risk, and improving cognitive function.
While, there is also a randomized controlled trial do not observe the effects of time-restricted eating on weight loss and decrease of metabolic risks.
Meanwhile, few studies have examined the effects of high-fiber diets or time-restricted eating on executive function.
Additionally, previous studies on high-fiber diets and time-restricted eating focused on middle-aged or elderly populations with some features of metabolic syndrome, while the effects on healthy young populations are unclear.
More importantly, there are a small amount of studies exploring the combined effects of time-restricted eating and physical activity on metabolism and cognitive function.
Therefore, our study is to estimate the effects of diet (high-fiber diets and time-restricted eating) and exercise (rope-skipping) interventions on body weight, cardiovascular metabolic markers, executive function, and intestinal flora among undergraduate students, as well as the underlying mechanisms.
Type d'étude
Interventionnel
Inscription (Anticipé)
200
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: Yanna Zhu, M.D
- Numéro de téléphone: 86-20-87330663
- E-mail: zhuyn3@mail.sysu.edu.cn
Sauvegarde des contacts de l'étude
- Nom: Ying Ding, M.M
- Numéro de téléphone: 86-20-87335573
- E-mail: dingy69@mail.sysu.edu.cn
Lieux d'étude
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Guangdong
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Guangzhou, Guangdong, Chine, 510080
- Recrutement
- Department of Maternal and Child Health and Sun Yat-sen Global Health Institute, School of Public Health and Institute of State Governance, Sun Yatsen University
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Contact:
- Yanna Zhu, M.D
- Numéro de téléphone: 86-20-87330663
- E-mail: zhuyn3@mail.sysu.edu.cn
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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
17 ans à 24 ans (Enfant, Adulte)
Accepte les volontaires sains
Oui
Sexes éligibles pour l'étude
Tout
La description
Inclusion Criteria:
- First and second year undergraduate students in Sun Yat-sen University.
- BMI≥22 kg/m^2.
- Keeping weight stable for 3 months prior to study start (weight fluctuation <5kg).
- Having the time and volunteering to receive the interventions.
Exclusion Criteria:
- Currently engaged in other weight-loss studies.
- With high blood pressure, diabetes or other cardiovascular diseases.
- With secondary obesity induced by medicine or other diseases.
- Contraindication to exercise.
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: La prévention
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Seul
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
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Expérimental: Rope-skipping group
Participants would be required to take part in an exercise plan, under the instruction and guidance of professional sports teachers.
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Exercice de saut à la corde trois fois par semaine (90 minutes à chaque fois, et il y a une pause de 10 minutes après 20 minutes de saut à la corde).
Un bracelet d'exercice et un bracelet intelligent seraient utilisés pour enregistrer la consommation d'énergie tout au long de l'étude.
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Expérimental: Diet intervention group
Participants would be required to take part in a diet plan , including a high-fiber diet and time-restricted eating.
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Diet interventions include ten-hour time-restricted eating and a high-fiber diet.
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Expérimental: Combined intervention group
Participants will receive both rope-skipping and diet interventions at the same time.
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Exercice de saut à la corde trois fois par semaine (90 minutes à chaque fois, et il y a une pause de 10 minutes après 20 minutes de saut à la corde).
Un bracelet d'exercice et un bracelet intelligent seraient utilisés pour enregistrer la consommation d'énergie tout au long de l'étude.
Diet interventions include ten-hour time-restricted eating and a high-fiber diet.
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Aucune intervention: Control group
Participants would be required to maintain existing diet patterns and physical activity levels.
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Body weight
Délai: Baseline (1-2 days before the intervention), right after intervention (12 weeks)
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Body weight change of participants
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Baseline (1-2 days before the intervention), right after intervention (12 weeks)
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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Body fat percentage
Délai: Baseline (1-2 days before the intervention), right after intervention (12 weeks)
|
Body fat percentage were measured by body composition analyzers.
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Baseline (1-2 days before the intervention), right after intervention (12 weeks)
|
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Fat mass
Délai: Baseline (1-2 days before the intervention), right after intervention (12 weeks)
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Fat mass (in kg) were measured by body composition analyzers.
|
Baseline (1-2 days before the intervention), right after intervention (12 weeks)
|
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Systolic and diastolic blood pressure
Délai: Baseline (1-2 days before the intervention), right after intervention (12 weeks)
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Sitting systolic and diastolic blood pressure were measured with a validated electronic blood pressure monitor (model OMRON,HEM-7124).
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Baseline (1-2 days before the intervention), right after intervention (12 weeks)
|
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Serum lipid levels
Délai: Baseline (1-2 days before the intervention), right after intervention (12 weeks)
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Serum lipid levels (total cholesterol, low-density lipoprotein cholesterol, high-density lipoprotein cholesterol, triglycerides) were analyzed by the enzymatic method.
|
Baseline (1-2 days before the intervention), right after intervention (12 weeks)
|
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Fasting plasma glucose
Délai: Baseline (1-2 days before the intervention), right after intervention (12 weeks)
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Fasting plasma glucose were analyzed by the glucose oxidase method.
|
Baseline (1-2 days before the intervention), right after intervention (12 weeks)
|
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Fasting plasma insulin
Délai: Baseline (1-2 days before the intervention), right after intervention (12 weeks)
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Fasting plasma glucose were analyzed by the electrochemiluminescence method.
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Baseline (1-2 days before the intervention), right after intervention (12 weeks)
|
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Intestinal flora
Délai: Baseline (1-2 days before the intervention), right after intervention (12 weeks)
|
To measure the change of intestinal flora by analyzing feces genome 16S rDNA.
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Baseline (1-2 days before the intervention), right after intervention (12 weeks)
|
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Change in scores on Behaviour Rating Inventory of Executive Functioning-Adult Version (BRIEF-A)
Délai: Baseline (1-2 days before the intervention), right after intervention (12 weeks)
|
The executive functions were measured by the Behavior Rating Inventory of Executive Function-Adult Version (BRIEF-A) Self-Report Form.
Items are rated 1 (never), 2 (sometimes), and 3 (often).
There is no range for a total score.
Raw scale scores are used to generate T-scores.
A reduction in score indicates less impairment.
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Baseline (1-2 days before the intervention), right after intervention (12 weeks)
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Change in appetite sensations
Délai: Baseline (1-2 days before the intervention), right after intervention (12 weeks)
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The appetite sensations were measured by the visual analogue scale (VAS).The VAS consisted of 100-mm lines and participants were required to place a vertical mark across the line corresponding best to their feelings of hunger, satisfaction, and fullness, with the scale ranging from 0 (not at all) to 100 (extremely).
Quantification was performed by measuring the distance between the left end of the line and the vertical mark.
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Baseline (1-2 days before the intervention), right after intervention (12 weeks)
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High-Sensitivity C-Reactive Protein (hs-CRP)
Délai: Baseline (1-2 days before the intervention), right after intervention (12 weeks)
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The levels of the serum hs-CRP were analyzed using the Luminex Human Magnetic Assay kit.
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Baseline (1-2 days before the intervention), right after intervention (12 weeks)
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Intercellular adhesion molecule-1 (ICAM-1)
Délai: Baseline (1-2 days before the intervention), right after intervention (12 weeks)
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The levels of the serum ICAM-1 were analyzed using the Luminex Human Magnetic Assay kit.
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Baseline (1-2 days before the intervention), right after intervention (12 weeks)
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Tumor necrosis factor alpha (TNF-alpha)
Délai: Baseline (1-2 days before the intervention), right after intervention (12 weeks)
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The levels of the serum TNF-alpha were analyzed using the Luminex Human Magnetic Assay kit.
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Baseline (1-2 days before the intervention), right after intervention (12 weeks)
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Chemokine CCL2
Délai: Baseline (1-2 days before the intervention), right after intervention (12 weeks)
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The levels of the serum chemokine CCL2 were analyzed using the Luminex Human Magnetic Assay kit.
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Baseline (1-2 days before the intervention), right after intervention (12 weeks)
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Vascular cell adhesion molecule (VCAM-1)
Délai: Baseline (1-2 days before the intervention), right after intervention (12 weeks)
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The levels of the serum VCAM-1 were analyzed using the Luminex Human Magnetic Assay kit.
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Baseline (1-2 days before the intervention), right after intervention (12 weeks)
|
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Interleukin-6 (IL-6)
Délai: Baseline (1-2 days before the intervention), right after intervention (12 weeks)
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The levels of the serum IL-6 were analyzed using the Luminex Human Magnetic Assay kit.
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Baseline (1-2 days before the intervention), right after intervention (12 weeks)
|
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Interleukin-8 (IL-8)
Délai: Baseline (1-2 days before the intervention), right after intervention (12 weeks)
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The levels of the IL-8 were analyzed using the Luminex Human Magnetic Assay kit.
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Baseline (1-2 days before the intervention), right after intervention (12 weeks)
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Leptin
Délai: Baseline (1-2 days before the intervention), right after intervention (12 weeks)
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The levels of the serum leptin were analyzed using the Luminex Human Magnetic Assay kit.
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Baseline (1-2 days before the intervention), right after intervention (12 weeks)
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Tau protein
Délai: Baseline (1-2 days before the intervention), right after intervention (12 weeks)
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The levels of the serum tau protein were analyzed using the Luminex Human Magnetic Assay kit.
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Baseline (1-2 days before the intervention), right after intervention (12 weeks)
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Brain-derived neurotrophic factor (BDNF)
Délai: Baseline (1-2 days before the intervention), right after intervention (12 weeks)
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The levels of the serum BDNF were analyzed using the Luminex Human Magnetic Assay kit.
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Baseline (1-2 days before the intervention), right after intervention (12 weeks)
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Vascular endothelial growth factor (VEGF)
Délai: Baseline (1-2 days before the intervention), right after intervention (12 weeks)
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The levels of the serum VEGF were analyzed using the Luminex Human Magnetic Assay kit.
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Baseline (1-2 days before the intervention), right after intervention (12 weeks)
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Circulating metabolome
Délai: Baseline (1-2 days before the intervention), right after intervention (12 weeks)
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To measure the change of circulating metabolome by LC-MS/MS method.
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Baseline (1-2 days before the intervention), right after intervention (12 weeks)
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Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Les enquêteurs
- Chercheur principal: Yanna Zhu, M.D, Sun Yat-sen University
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)
2 avril 2021
Achèvement primaire (Anticipé)
31 décembre 2022
Achèvement de l'étude (Anticipé)
28 février 2023
Dates d'inscription aux études
Première soumission
3 avril 2021
Première soumission répondant aux critères de contrôle qualité
6 avril 2021
Première publication (Réel)
8 avril 2021
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
22 septembre 2021
Dernière mise à jour soumise répondant aux critères de contrôle qualité
21 septembre 2021
Dernière vérification
1 septembre 2021
Plus d'information
Termes liés à cette étude
Autres numéros d'identification d'étude
- ZDGW[2021]044
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
NON
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 .