- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04834687
Effects of Diet and Exercise Interventions on Cardiometabolic Risk Markers, Executive Function, and Intestinal Flora
September 21, 2021 updated by: 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.
Study Overview
Status
Recruiting
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Anticipated)
200
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Yanna Zhu, M.D
- Phone Number: 86-20-87330663
- Email: zhuyn3@mail.sysu.edu.cn
Study Contact Backup
- Name: Ying Ding, M.M
- Phone Number: 86-20-87335573
- Email: dingy69@mail.sysu.edu.cn
Study Locations
-
-
Guangdong
-
Guangzhou, Guangdong, China, 510080
- Recruiting
- 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
-
Contact:
- Yanna Zhu, M.D
- Phone Number: 86-20-87330663
- Email: zhuyn3@mail.sysu.edu.cn
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
17 years to 24 years (Child, Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Rope-skipping group
Participants would be required to take part in an exercise plan, under the instruction and guidance of professional sports teachers.
|
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.
|
Experimental: Diet intervention group
Participants would be required to take part in a diet plan , including a high-fiber diet and time-restricted eating.
|
Diet interventions include ten-hour time-restricted eating and a high-fiber diet.
|
Experimental: Combined intervention group
Participants will receive both rope-skipping and diet interventions at the same time.
|
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.
|
No Intervention: Control group
Participants would be required to maintain existing diet patterns and physical activity levels.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Body weight
Time Frame: 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)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Body fat percentage
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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)
Time Frame: 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
Time Frame: 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)
Time Frame: 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)
Time Frame: 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)
Time Frame: 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
Time Frame: 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)
Time Frame: 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)
Time Frame: 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)
Time Frame: 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
Time Frame: 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
Time Frame: 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)
Time Frame: 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)
Time Frame: 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
Time Frame: 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)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Yanna Zhu, M.D, Sun Yat-sen University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
April 2, 2021
Primary Completion (Anticipated)
December 31, 2022
Study Completion (Anticipated)
February 28, 2023
Study Registration Dates
First Submitted
April 3, 2021
First Submitted That Met QC Criteria
April 6, 2021
First Posted (Actual)
April 8, 2021
Study Record Updates
Last Update Posted (Actual)
September 22, 2021
Last Update Submitted That Met QC Criteria
September 21, 2021
Last Verified
September 1, 2021
More Information
Terms related to this study
Other Study ID Numbers
- ZDGW[2021]044
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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