Effects of Diet and Exercise Interventions on Cardiometabolic Risk Markers, Executive Function, and Intestinal Flora
21. september 2021 oppdatert av: 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.
Studieoversikt
Status
Rekruttering
Intervensjon / Behandling
Detaljert 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.
Studietype
Intervensjonell
Registrering (Forventet)
200
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiekontakt
- Navn: Yanna Zhu, M.D
- Telefonnummer: 86-20-87330663
- E-post: zhuyn3@mail.sysu.edu.cn
Studer Kontakt Backup
- Navn: Ying Ding, M.M
- Telefonnummer: 86-20-87335573
- E-post: 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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Ta kontakt med:
- Yanna Zhu, M.D
- Telefonnummer: 86-20-87330663
- E-post: zhuyn3@mail.sysu.edu.cn
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Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
17 år til 24 år (Barn, Voksen)
Tar imot friske frivillige
Ja
Kjønn som er kvalifisert for studier
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
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Forebygging
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Enkelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
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Eksperimentell: 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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Tauhopping tre ganger i uken (90 minutter hver gang, og det er 10 min pause etter 20 min Tauhopping).
Treningsarmbånd og smart armbånd vil bli brukt til å registrere energiforbruket gjennom hele studiet.
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Eksperimentell: 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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Eksperimentell: Combined intervention group
Participants will receive both rope-skipping and diet interventions at the same time.
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Tauhopping tre ganger i uken (90 minutter hver gang, og det er 10 min pause etter 20 min Tauhopping).
Treningsarmbånd og smart armbånd vil bli brukt til å registrere energiforbruket gjennom hele studiet.
Diet interventions include ten-hour time-restricted eating and a high-fiber diet.
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Ingen inngripen: Control group
Participants would be required to maintain existing diet patterns and physical activity levels.
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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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 |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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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)
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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
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)
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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
Tidsramme: 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)
Tidsramme: 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
Tidsramme: 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)
Tidsramme: 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)
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)
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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)
Tidsramme: 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)
Tidsramme: 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)
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)
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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)
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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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Etterforskere
- Hovedetterforsker: Yanna Zhu, M.D, Sun Yat-sen University
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Faktiske)
2. april 2021
Primær fullføring (Forventet)
31. desember 2022
Studiet fullført (Forventet)
28. februar 2023
Datoer for studieregistrering
Først innsendt
3. april 2021
Først innsendt som oppfylte QC-kriteriene
6. april 2021
Først lagt ut (Faktiske)
8. april 2021
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
22. september 2021
Siste oppdatering sendt inn som oppfylte QC-kriteriene
21. september 2021
Sist bekreftet
1. september 2021
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Andre studie-ID-numre
- ZDGW[2021]044
Plan for individuelle deltakerdata (IPD)
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NEI
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Nei
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