- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT04834687
Effects of Diet and Exercise Interventions on Cardiometabolic Risk Markers, Executive Function, and Intestinal Flora
21. september 2021 opdateret af: 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.
Studieoversigt
Status
Rekruttering
Intervention / Behandling
Detaljeret beskrivelse
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.
Undersøgelsestype
Interventionel
Tilmelding (Forventet)
200
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiekontakt
- Navn: Yanna Zhu, M.D
- Telefonnummer: 86-20-87330663
- E-mail: zhuyn3@mail.sysu.edu.cn
Undersøgelse Kontakt Backup
- Navn: Ying Ding, M.M
- Telefonnummer: 86-20-87335573
- E-mail: dingy69@mail.sysu.edu.cn
Studiesteder
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Guangdong
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Guangzhou, Guangdong, Kina, 510080
- Rekruttering
- 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
- Telefonnummer: 86-20-87330663
- E-mail: zhuyn3@mail.sysu.edu.cn
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-
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
17 år til 24 år (Barn, Voksen)
Tager imod sunde frivillige
Ja
Køn, der er berettiget til at studere
Alle
Beskrivelse
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.
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Forebyggelse
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Enkelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
---|---|
Eksperimentel: 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 øvelse tre gange om ugen (90 minutter hver gang, og der er 10 min pause efter 20 min Rope skipping).
Træningsarmbånd og smart armbånd vil blive brugt til at registrere energiforbruget gennem hele undersøgelsen.
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Eksperimentel: 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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Eksperimentel: Combined intervention group
Participants will receive both rope-skipping and diet interventions at the same time.
|
Rope-skipping øvelse tre gange om ugen (90 minutter hver gang, og der er 10 min pause efter 20 min Rope skipping).
Træningsarmbånd og smart armbånd vil blive brugt til at registrere energiforbruget gennem hele undersøgelsen.
Diet interventions include ten-hour time-restricted eating and a high-fiber diet.
|
Ingen indgriben: Control group
Participants would be required to maintain existing diet patterns and physical activity levels.
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Body weight
Tidsramme: 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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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Body fat percentage
Tidsramme: 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
Tidsramme: 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
Tidsramme: Baseline (1-2 days before the intervention), right after intervention (12 weeks)
|
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
Tidsramme: 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
Tidsramme: 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
Tidsramme: Baseline (1-2 days before the intervention), right after intervention (12 weeks)
|
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
Tidsramme: 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)
Tidsramme: 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
Tidsramme: Baseline (1-2 days before the intervention), right after intervention (12 weeks)
|
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)
Tidsramme: Baseline (1-2 days before the intervention), right after intervention (12 weeks)
|
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)
Tidsramme: 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)
Tidsramme: 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
Tidsramme: Baseline (1-2 days before the intervention), right after intervention (12 weeks)
|
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)
Tidsramme: Baseline (1-2 days before the intervention), right after intervention (12 weeks)
|
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)
Tidsramme: Baseline (1-2 days before the intervention), right after intervention (12 weeks)
|
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)
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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)
Tidsramme: Baseline (1-2 days before the intervention), right after intervention (12 weeks)
|
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)
Tidsramme: 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
Tidsramme: 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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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Efterforskere
- Ledende efterforsker: Yanna Zhu, M.D, Sun Yat-sen University
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Faktiske)
2. april 2021
Primær færdiggørelse (Forventet)
31. december 2022
Studieafslutning (Forventet)
28. februar 2023
Datoer for studieregistrering
Først indsendt
3. april 2021
Først indsendt, der opfyldte QC-kriterier
6. april 2021
Først opslået (Faktiske)
8. april 2021
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
22. september 2021
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
21. september 2021
Sidst verificeret
1. september 2021
Mere information
Begreber relateret til denne undersøgelse
Andre undersøgelses-id-numre
- ZDGW[2021]044
Plan for individuelle deltagerdata (IPD)
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