Effects of Diet and Exercise Interventions on Cardiometabolic Risk Markers, Executive Function, and Intestinal Flora
1 other identifier
interventional
200
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Apr 2021
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 2, 2021
CompletedFirst Submitted
Initial submission to the registry
April 3, 2021
CompletedFirst Posted
Study publicly available on registry
April 8, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
February 28, 2023
CompletedSeptember 22, 2021
September 1, 2021
1.7 years
April 3, 2021
September 21, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Body weight
Body weight change of participants
Baseline (1-2 days before the intervention), right after intervention (12 weeks)
Secondary Outcomes (21)
Body fat percentage
Baseline (1-2 days before the intervention), right after intervention (12 weeks)
Fat mass
Baseline (1-2 days before the intervention), right after intervention (12 weeks)
Systolic and diastolic blood pressure
Baseline (1-2 days before the intervention), right after intervention (12 weeks)
Serum lipid levels
Baseline (1-2 days before the intervention), right after intervention (12 weeks)
Fasting plasma glucose
Baseline (1-2 days before the intervention), right after intervention (12 weeks)
- +16 more secondary outcomes
Study Arms (4)
Rope-skipping group
EXPERIMENTALParticipants would be required to take part in an exercise plan, under the instruction and guidance of professional sports teachers.
Diet intervention group
EXPERIMENTALParticipants would be required to take part in a diet plan , including a high-fiber diet and time-restricted eating.
Combined intervention group
EXPERIMENTALParticipants will receive both rope-skipping and diet interventions at the same time.
Control group
NO INTERVENTIONParticipants would be required to maintain existing diet patterns and physical activity levels.
Interventions
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 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 .
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
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, 510080, China
Related Publications (2)
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.
PMID: 39802638DERIVEDLin 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.
PMID: 37803759DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Yanna Zhu, M.D
Sun Yat-sen University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor
Study Record Dates
First Submitted
April 3, 2021
First Posted
April 8, 2021
Study Start
April 2, 2021
Primary Completion
December 31, 2022
Study Completion
February 28, 2023
Last Updated
September 22, 2021
Record last verified: 2021-09
Data Sharing
- IPD Sharing
- Will not share