Clinical trial NCT04834687: Effects of Diet and Exercise Interventions on Cardiometabolic Risk Markers, Executive Function, and Intestinal Flora
Official title: Effects of Diet and Exercise Interventions on Cardiometabolic Risk Markers, Executive Function, and Intestinal Flora in Undergraduate Students: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Cardiometabolic Risk
Executive Function
Intestinal Microbiome
Keywords: Dietary Fiber
Time Restricted Feeding
Exercise
Young Adult
Lead sponsor: Sun Yat-sen University
Sponsor class: OTHER
First posted: 2021-04-08
Enrollment: 200
Sex: ALL
Minimum age (years): 17
Maximum age (years): 24
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Body weight
timeFrame: Baseline (1-2 days before the intervention), right after intervention (12 weeks)
Secondary outcomes:
measure: Body fat percentage
timeFrame: Baseline (1-2 days before the intervention), right after intervention (12 weeks)
measure: Fat mass
timeFrame: Baseline (1-2 days before the intervention), right after intervention (12 weeks)
measure: Systolic and diastolic blood pressure
timeFrame: Baseline (1-2 days before the intervention), right after intervention (12 weeks)
measure: Serum lipid levels
timeFrame: Baseline (1-2 days before the intervention), right after intervention (12 weeks)
measure: Fasting plasma glucose
timeFrame: Baseline (1-2 days before the intervention), right after intervention (12 weeks)
measure: Fasting plasma insulin
timeFrame: Baseline (1-2 days before the intervention), right after intervention (12 weeks)
measure: Intestinal flora
timeFrame: Baseline (1-2 days before the intervention), right after intervention (12 weeks)
measure: Change in scores on Behaviour Rating Inventory of Executive Functioning-Adult Version (BRIEF-A)
timeFrame: Baseline (1-2 days before the intervention), right after intervention (12 weeks)
measure: Change in appetite sensations
timeFrame: Baseline (1-2 days before the intervention), right after intervention (12 weeks)
measure: High-Sensitivity C-Reactive Protein (hs-CRP)
timeFrame: Baseline (1-2 days before the intervention), right after intervention (12 weeks)
measure: Intercellular adhesion molecule-1 (ICAM-1)
timeFrame: Baseline (1-2 days before the intervention), right after intervention (12 weeks)
measure: Tumor necrosis factor alpha (TNF-alpha)
timeFrame: Baseline (1-2 days before the intervention), right after intervention (12 weeks)
measure: Chemokine CCL2
timeFrame: Baseline (1-2 days before the intervention), right after intervention (12 weeks)
measure: Vascular cell adhesion molecule (VCAM-1)
timeFrame: Baseline (1-2 days before the intervention), right after intervention (12 weeks)
measure: Interleukin-6 (IL-6)
timeFrame: Baseline (1-2 days before the intervention), right after intervention (12 weeks)
measure: Interleukin-8 (IL-8)
timeFrame: Baseline (1-2 days before the intervention), right after intervention (12 weeks)
measure: Leptin
timeFrame: Baseline (1-2 days before the intervention), right after intervention (12 weeks)
measure: Tau protein
timeFrame: Baseline (1-2 days before the intervention), right after intervention (12 weeks)
measure: Brain-derived neurotrophic factor (BDNF)
timeFrame: Baseline (1-2 days before the intervention), right after intervention (12 weeks)
measure: Vascular endothelial growth factor (VEGF)
timeFrame: Baseline (1-2 days before the intervention), right after intervention (12 weeks)
measure: Circulating metabolome
timeFrame: Baseline (1-2 days before the intervention), right after intervention (12 weeks)
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: 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
state: Guangdong
Study officials:
affiliation: Sun Yat-sen University
name: Yanna Zhu, M.D
role: PRINCIPAL_INVESTIGATOR
References: