Effects of Diet and Exercise Interventions on Cardiometabolic Risk Markers, Executive Function, and Intestinal Flora
21. září 2021 aktualizováno: 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.
Přehled studie
Postavení
Nábor
Intervence / Léčba
Detailní popis
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.
Typ studie
Intervenční
Zápis (Očekávaný)
200
Fáze
- Nelze použít
Kontakty a umístění
Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.
Studijní kontakt
- Jméno: Yanna Zhu, M.D
- Telefonní číslo: 86-20-87330663
- E-mail: zhuyn3@mail.sysu.edu.cn
Studijní záloha kontaktů
- Jméno: Ying Ding, M.M
- Telefonní číslo: 86-20-87335573
- E-mail: dingy69@mail.sysu.edu.cn
Studijní místa
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Guangdong
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Guangzhou, Guangdong, Čína, 510080
- Nábor
- 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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Kontakt:
- Yanna Zhu, M.D
- Telefonní číslo: 86-20-87330663
- E-mail: zhuyn3@mail.sysu.edu.cn
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-
Kritéria účasti
Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.
Kritéria způsobilosti
Věk způsobilý ke studiu
17 let až 24 let (Dítě, Dospělý)
Přijímá zdravé dobrovolníky
Ano
Pohlaví způsobilá ke studiu
Všechno
Popis
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.
Studijní plán
Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.
Jak je studie koncipována?
Detaily designu
- Primární účel: Prevence
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Singl
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
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Experimentální: 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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Rope-skipping cvičení třikrát týdně (pokaždé 90 minut a po 20 minutách skákání přes švihadlo je 10 minut přestávka).
Cvičební náramek a chytrý náramek by byly použity k zaznamenávání spotřeby energie po celou dobu studie.
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Experimentální: 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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Experimentální: Combined intervention group
Participants will receive both rope-skipping and diet interventions at the same time.
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Rope-skipping cvičení třikrát týdně (pokaždé 90 minut a po 20 minutách skákání přes švihadlo je 10 minut přestávka).
Cvičební náramek a chytrý náramek by byly použity k zaznamenávání spotřeby energie po celou dobu studie.
Diet interventions include ten-hour time-restricted eating and a high-fiber diet.
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Žádný zásah: Control group
Participants would be required to maintain existing diet patterns and physical activity levels.
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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Body weight
Časové okno: 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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Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Body fat percentage
Časové okno: Baseline (1-2 days before the intervention), right after intervention (12 weeks)
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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
Časové okno: 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.
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Baseline (1-2 days before the intervention), right after intervention (12 weeks)
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Systolic and diastolic blood pressure
Časové okno: 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
Časové okno: 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.
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Baseline (1-2 days before the intervention), right after intervention (12 weeks)
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Fasting plasma glucose
Časové okno: 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.
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Baseline (1-2 days before the intervention), right after intervention (12 weeks)
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Fasting plasma insulin
Časové okno: 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
Časové okno: Baseline (1-2 days before the intervention), right after intervention (12 weeks)
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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)
Časové okno: Baseline (1-2 days before the intervention), right after intervention (12 weeks)
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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
Časové okno: 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)
Časové okno: 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)
Časové okno: 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)
Časové okno: 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
Časové okno: 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)
Časové okno: 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)
Časové okno: 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)
Časové okno: 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
Časové okno: 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
Časové okno: 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)
Časové okno: 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)
Časové okno: 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
Časové okno: 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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Spolupracovníci a vyšetřovatelé
Zde najdete lidi a organizace zapojené do této studie.
Sponzor
Vyšetřovatelé
- Vrchní vyšetřovatel: Yanna Zhu, M.D, Sun Yat-sen University
Termíny studijních záznamů
Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.
Hlavní termíny studia
Začátek studia (Aktuální)
2. dubna 2021
Primární dokončení (Očekávaný)
31. prosince 2022
Dokončení studie (Očekávaný)
28. února 2023
Termíny zápisu do studia
První předloženo
3. dubna 2021
První předloženo, které splnilo kritéria kontroly kvality
6. dubna 2021
První zveřejněno (Aktuální)
8. dubna 2021
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
22. září 2021
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
21. září 2021
Naposledy ověřeno
1. září 2021
Více informací
Termíny související s touto studií
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Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .