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

NCT ID: NCT04834687

Last Updated: 2021-09-22

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-04-02
• Study Completion Date: 2023-02-28

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.

Conditions

Cardiometabolic Risk; Executive Function; Intestinal Microbiome

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

Rope-skipping group

Participants would be required to take part in an exercise plan, under the instruction and guidance of professional sports teachers.

Group Type: EXPERIMENTAL

Exercise

Intervention Type: BEHAVIORAL

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 intervention group

Participants would be required to take part in a diet plan , including a high-fiber diet and time-restricted eating.

Group Type: EXPERIMENTAL

Diet

Intervention Type: BEHAVIORAL

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 .

Combined intervention group

Participants will receive both rope-skipping and diet interventions at the same time.

Group Type: EXPERIMENTAL

Exercise

Intervention Type: BEHAVIORAL

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

Intervention Type: BEHAVIORAL

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 .

Control group

Participants would be required to maintain existing diet patterns and physical activity levels.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: BEHAVIORAL

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 .

Intervention Type: BEHAVIORAL

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.

• Minimum Eligible Age: 17 Years
• Maximum Eligible Age: 24 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Sun Yat-sen University

OTHER

Sponsor Role: lead

Responsible Party

Yanna Zhu

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Yanna Zhu, M.D

Role: PRINCIPAL_INVESTIGATOR

Sun Yat-sen University

Locations

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, China

Site Status: RECRUITING

Countries

China

Central Contacts

Yanna Zhu, M.D

Role: CONTACT

zhuyn3@mail.sysu.edu.cn

86-20-87330663

Ying Ding, M.M

Role: CONTACT

dingy69@mail.sysu.edu.cn

86-20-87335573

Facility Contacts

Yanna Zhu, M.D

Role: primary

zhuyn3@mail.sysu.edu.cn

86-20-87330663

References

Lin Z, Li T, Huang F, Wu M, Zhu L, Zhou Y, Ming YA, Lu Z, Peng W, Gao F, Zhu Y. Comparison of diet and exercise on cardiometabolic factors in young adults with overweight/obesity: multiomics analysis and gut microbiota prediction, a randomized controlled trial. MedComm (2020). 2025 Jan 12;6(1):e70044. doi: 10.1002/mco2.70044. eCollection 2025 Jan.

Reference Type: DERIVED

PMID: 39802638 (View on PubMed)

Lin Z, Zhang X, Wu M, Ming Y, Wang X, Li H, Huang F, Gao F, Zhu Y. High-fiber diet and rope-skipping benefit cardiometabolic health and modulate gut microbiota in young adults: A randomized controlled trial. Food Res Int. 2023 Nov;173(Pt 2):113421. doi: 10.1016/j.foodres.2023.113421. Epub 2023 Aug 30.

Reference Type: DERIVED

PMID: 37803759 (View on PubMed)

Other Identifiers

ZDGW[2021]044

Identifier Type: -

Identifier Source: org_study_id