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

21 września 2021 zaktualizowane przez: 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.

Przegląd badań

Status

Rekrutacyjny

Warunki

Interwencja / Leczenie

Szczegółowy opis

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 studiów

Interwencyjne

Zapisy (Oczekiwany)

200

Faza

  • Nie dotyczy

Kontakty i lokalizacje

Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.

Kontakt w sprawie studiów

Kopia zapasowa kontaktu do badania

Lokalizacje studiów

  • Chiny
    • Guangdong
      • Guangzhou, Guangdong, Chiny, 510080
        • Rekrutacyjny
        • 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:

Kryteria uczestnictwa

Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.

Kryteria kwalifikacji

Wiek uprawniający do nauki

17 lat do 24 lata (Dziecko, Dorosły)

Akceptuje zdrowych ochotników

Tak

Płeć kwalifikująca się do nauki

Wszystko

Opis

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 studiów

Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.

Jak projektuje się badanie?

Szczegóły projektu

  • Główny cel: Zapobieganie
  • Przydział: Randomizowane
  • Model interwencyjny: Przydział równoległy
  • Maskowanie: Pojedynczy

Broń i interwencje

Grupa uczestników / Arm
Interwencja / Leczenie
Eksperymentalny: Rope-skipping group
Participants would be required to take part in an exercise plan, under the instruction and guidance of professional sports teachers.
Behawioralne: Ćwiczenia
Ćwiczenia na skakance trzy razy w tygodniu (każdorazowo po 90 minut, po 20 minutach na skakance 10 minut przerwy). Bransoletka do ćwiczeń i inteligentna bransoletka byłyby używane do rejestrowania zużycia energii podczas badania.
Eksperymentalny: Diet intervention group
Participants would be required to take part in a diet plan , including a high-fiber diet and time-restricted eating.
Behawioralne: 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 .
Eksperymentalny: Combined intervention group
Participants will receive both rope-skipping and diet interventions at the same time.
Behawioralne: Ćwiczenia
Ćwiczenia na skakance trzy razy w tygodniu (każdorazowo po 90 minut, po 20 minutach na skakance 10 minut przerwy). Bransoletka do ćwiczeń i inteligentna bransoletka byłyby używane do rejestrowania zużycia energii podczas badania.
Behawioralne: 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 .
Brak interwencji: Control group
Participants would be required to maintain existing diet patterns and physical activity levels.

Co mierzy badanie?

Podstawowe miary wyniku

Miara wyniku
Opis środka
Ramy czasowe
Body weight
Ramy czasowe: 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)

Miary wyników drugorzędnych

Miara wyniku
Opis środka
Ramy czasowe
Body fat percentage
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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)
Ramy czasowe: 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
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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
Ramy czasowe: 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)

Współpracownicy i badacze

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

Sponsor

Sun Yat-sen University

Śledczy

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

Daty zapisu na studia

Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.

Główne daty studiów

Rozpoczęcie studiów (Rzeczywisty)

2 kwietnia 2021

Zakończenie podstawowe (Oczekiwany)

31 grudnia 2022

Ukończenie studiów (Oczekiwany)

28 lutego 2023

Daty rejestracji na studia

Pierwszy przesłany

3 kwietnia 2021

Pierwszy przesłany, który spełnia kryteria kontroli jakości

6 kwietnia 2021

Pierwszy wysłany (Rzeczywisty)

8 kwietnia 2021

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Rzeczywisty)

22 września 2021

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

21 września 2021

Ostatnia weryfikacja

1 września 2021

Więcej informacji

Terminy związane z tym badaniem

Słowa kluczowe

Inne numery identyfikacyjne badania

  • ZDGW[2021]044

Plan dla danych uczestnika indywidualnego (IPD)

Planujesz udostępniać dane poszczególnych uczestników (IPD)?

NIE

Informacje o lekach i urządzeniach, dokumenty badawcze

Bada produkt leczniczy regulowany przez amerykańską FDA

Nie

Bada produkt urządzenia regulowany przez amerykańską FDA

Nie

Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .

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