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

Executive Function Clinical Trial

Official title:

Effects of Diet and Exercise Interventions on Cardiometabolic Risk Markers, Executive Function, and Intestinal Flora in Undergraduate Students: a Randomized Controlled Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04834687
• Other study ID #: ZDGW[2021]044
• Status: Recruiting
• Phase: N/A
• Start date: April 2, 2021
• Est. completion date: February 28, 2023

Study information

• Verified date: September 2021
• Source: Sun Yat-sen University
• Contact: Yanna Zhu, M.D
• Phone: 86-20-87330663
• Email: zhuyn3[@]mail.sysu.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: February 28, 2023
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 17 Years to 24 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cardiometabolic Risk
• Executive Function
• Intestinal Microbiome

Intervention

Behavioral:
• Exercise
Rope-skipping exercise for three times a week (90 minutes each time, and there is a 10 min break after 20 min Rope skipping). Exercise bracelet and smart bracelet would be used to record the energy consumption throughout the study.
• Diet
Diet interventions include ten-hour time-restricted eating and a high-fiber diet. 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. 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 .

Locations

Country	Name	City	State
China	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	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Sun Yat-sen University

Country where clinical trial is conducted

China, 

Outcome

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