Diese Seite wurde automatisch übersetzt und die Genauigkeit der Übersetzung wird nicht garantiert. Bitte wende dich an die englische Version für einen Quelltext.

Effects of Diet and Exercise Interventions on Cardiometabolic Risk Markers, Executive Function, and Intestinal Flora

21. September 2021 aktualisiert von: 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.

Studienübersicht

Status

Rekrutierung

Bedingungen

Intervention / Behandlung

Detaillierte Beschreibung

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.

Studientyp

Interventionell

Einschreibung (Voraussichtlich)

200

Phase

  • Unzutreffend

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienkontakt

Studieren Sie die Kontaktsicherung

Studienorte

  • China
    • Guangdong
      • Guangzhou, Guangdong, China, 510080
        • Rekrutierung
        • 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
        • Kontakt:

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

17 Jahre bis 24 Jahre (Kind, Erwachsene)

Akzeptiert gesunde Freiwillige

Ja

Studienberechtigte Geschlechter

Alle

Beschreibung

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.

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Verhütung
  • Zuteilung: Zufällig
  • Interventionsmodell: Parallele Zuordnung
  • Maskierung: Single

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Experimental: Rope-skipping group
Participants would be required to take part in an exercise plan, under the instruction and guidance of professional sports teachers.
Verhalten: Übung
Dreimal pro Woche Seilspringen (jeweils 90 Minuten, nach 20 Minuten Seilspringen gibt es eine 10-minütige Pause). Zur Aufzeichnung des Energieverbrauchs während der gesamten Studie würden ein Trainingsarmband und ein Smart-Armband verwendet.
Experimental: Diet intervention group
Participants would be required to take part in a diet plan , including a high-fiber diet and time-restricted eating.
Verhalten: Diet

Diet interventions include ten-hour time-restricted eating and a high-fiber diet.

  1. Participants will be instructed to take food from 7:30 AM until 5:30 PM and completely abstain from caloric intake for the remainder of the day (14 hours fast:10 hours eat). Only noncaloric beverages were permitted outside of the eating widow.
  2. According to the dietary recommendation proposed by Chinese Government and the existing dishes in the canteen , participants are instructed to eat following a high-diet recipe weekly from Monday to Friday which includes whole grain wheat rice, vegetables, fruits, and other foods rich in dietary fiber .
Experimental: Combined intervention group
Participants will receive both rope-skipping and diet interventions at the same time.
Verhalten: Übung
Dreimal pro Woche Seilspringen (jeweils 90 Minuten, nach 20 Minuten Seilspringen gibt es eine 10-minütige Pause). Zur Aufzeichnung des Energieverbrauchs während der gesamten Studie würden ein Trainingsarmband und ein Smart-Armband verwendet.
Verhalten: Diet

Diet interventions include ten-hour time-restricted eating and a high-fiber diet.

  1. Participants will be instructed to take food from 7:30 AM until 5:30 PM and completely abstain from caloric intake for the remainder of the day (14 hours fast:10 hours eat). Only noncaloric beverages were permitted outside of the eating widow.
  2. According to the dietary recommendation proposed by Chinese Government and the existing dishes in the canteen , participants are instructed to eat following a high-diet recipe weekly from Monday to Friday which includes whole grain wheat rice, vegetables, fruits, and other foods rich in dietary fiber .
Kein Eingriff: Control group
Participants would be required to maintain existing diet patterns and physical activity levels.

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Body weight
Zeitfenster: Baseline (1-2 days before the intervention), right after intervention (12 weeks)
Body weight change of participants
Baseline (1-2 days before the intervention), right after intervention (12 weeks)

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Body fat percentage
Zeitfenster: Baseline (1-2 days before the intervention), right after intervention (12 weeks)
Body fat percentage were measured by body composition analyzers.
Baseline (1-2 days before the intervention), right after intervention (12 weeks)
Fat mass
Zeitfenster: Baseline (1-2 days before the intervention), right after intervention (12 weeks)
Fat mass (in kg) were measured by body composition analyzers.
Baseline (1-2 days before the intervention), right after intervention (12 weeks)
Systolic and diastolic blood pressure
Zeitfenster: 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).
Baseline (1-2 days before the intervention), right after intervention (12 weeks)
Serum lipid levels
Zeitfenster: Baseline (1-2 days before the intervention), right after intervention (12 weeks)
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)
Fasting plasma glucose
Zeitfenster: Baseline (1-2 days before the intervention), right after intervention (12 weeks)
Fasting plasma glucose were analyzed by the glucose oxidase method.
Baseline (1-2 days before the intervention), right after intervention (12 weeks)
Fasting plasma insulin
Zeitfenster: Baseline (1-2 days before the intervention), right after intervention (12 weeks)
Fasting plasma glucose were analyzed by the electrochemiluminescence method.
Baseline (1-2 days before the intervention), right after intervention (12 weeks)
Intestinal flora
Zeitfenster: 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.
Baseline (1-2 days before the intervention), right after intervention (12 weeks)
Change in scores on Behaviour Rating Inventory of Executive Functioning-Adult Version (BRIEF-A)
Zeitfenster: 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.
Baseline (1-2 days before the intervention), right after intervention (12 weeks)
Change in appetite sensations
Zeitfenster: 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.
Baseline (1-2 days before the intervention), right after intervention (12 weeks)
High-Sensitivity C-Reactive Protein (hs-CRP)
Zeitfenster: 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.
Baseline (1-2 days before the intervention), right after intervention (12 weeks)
Intercellular adhesion molecule-1 (ICAM-1)
Zeitfenster: Baseline (1-2 days before the intervention), right after intervention (12 weeks)
The levels of the serum ICAM-1 were analyzed using the Luminex Human Magnetic Assay kit.
Baseline (1-2 days before the intervention), right after intervention (12 weeks)
Tumor necrosis factor alpha (TNF-alpha)
Zeitfenster: Baseline (1-2 days before the intervention), right after intervention (12 weeks)
The levels of the serum TNF-alpha were analyzed using the Luminex Human Magnetic Assay kit.
Baseline (1-2 days before the intervention), right after intervention (12 weeks)
Chemokine CCL2
Zeitfenster: 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.
Baseline (1-2 days before the intervention), right after intervention (12 weeks)
Vascular cell adhesion molecule (VCAM-1)
Zeitfenster: 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.
Baseline (1-2 days before the intervention), right after intervention (12 weeks)
Interleukin-6 (IL-6)
Zeitfenster: 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.
Baseline (1-2 days before the intervention), right after intervention (12 weeks)
Interleukin-8 (IL-8)
Zeitfenster: Baseline (1-2 days before the intervention), right after intervention (12 weeks)
The levels of the IL-8 were analyzed using the Luminex Human Magnetic Assay kit.
Baseline (1-2 days before the intervention), right after intervention (12 weeks)
Leptin
Zeitfenster: Baseline (1-2 days before the intervention), right after intervention (12 weeks)
The levels of the serum leptin were analyzed using the Luminex Human Magnetic Assay kit.
Baseline (1-2 days before the intervention), right after intervention (12 weeks)
Tau protein
Zeitfenster: Baseline (1-2 days before the intervention), right after intervention (12 weeks)
The levels of the serum tau protein were analyzed using the Luminex Human Magnetic Assay kit.
Baseline (1-2 days before the intervention), right after intervention (12 weeks)
Brain-derived neurotrophic factor (BDNF)
Zeitfenster: 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.
Baseline (1-2 days before the intervention), right after intervention (12 weeks)
Vascular endothelial growth factor (VEGF)
Zeitfenster: Baseline (1-2 days before the intervention), right after intervention (12 weeks)
The levels of the serum VEGF were analyzed using the Luminex Human Magnetic Assay kit.
Baseline (1-2 days before the intervention), right after intervention (12 weeks)
Circulating metabolome
Zeitfenster: Baseline (1-2 days before the intervention), right after intervention (12 weeks)
To measure the change of circulating metabolome by LC-MS/MS method.
Baseline (1-2 days before the intervention), right after intervention (12 weeks)

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

Sun Yat-sen University

Ermittler

  • Hauptermittler: Yanna Zhu, M.D, Sun Yat-sen University

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Tatsächlich)

2. April 2021

Primärer Abschluss (Voraussichtlich)

31. Dezember 2022

Studienabschluss (Voraussichtlich)

28. Februar 2023

Studienanmeldedaten

Zuerst eingereicht

3. April 2021

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

6. April 2021

Zuerst gepostet (Tatsächlich)

8. April 2021

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

22. September 2021

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

21. September 2021

Zuletzt verifiziert

1. September 2021

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Schlüsselwörter

Andere Studien-ID-Nummern

  • ZDGW[2021]044

Plan für individuelle Teilnehmerdaten (IPD)

Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?

NEIN

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Nein

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .

Abonnieren