Cardiometabolic RiskNCT04834687
Effects of Diet and Exercise Interventions on Cardiometabolic Risk Markers, Executive Function, and Intestinal Flora
A study testing Exercise and Diet in people with Cardiometabolic Risk and Executive Function, run by Sun Yat-sen University at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 17 to 24 yearsHealthy volunteers can take part
- Conditions the study is for
- Cardiometabolic Risk, Executive Function, Intestinal Microbiome
- What is being tested?
- Exercise and Diet
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- 2 Apr 2021to 28 Feb 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 17 to 24 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- 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
Guangzhou, Guangdong, 510080
Yanna Zhu, M.D, 86-20-87330663, zhuyn3@mail.sysu.edu.cn
About this study
Official title: 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.
Read the 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.
- Being tested
- Exercise, Diet
- Keywords
- Dietary Fiber, Time Restricted Feeding, Exercise, Young Adult
- Medical subject headings
- Intermittent Fasting, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExerciseBehavioural
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.
DietBehavioural
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 .
| Study group | Role | What they receive |
|---|---|---|
| Rope-skipping group | Experimental | Participants would be required to take part in an exercise plan, under the instruction and guidance of professional sports teachers. Receives: Behavioral: Exercise |
| Diet intervention group | Experimental | Participants would be required to take part in a diet plan , including a high-fiber diet and time-restricted eating. Receives: Behavioral: Diet |
| Combined intervention group | Experimental | Participants will receive both rope-skipping and diet interventions at the same time. Receives: Behavioral: Exercise; Behavioral: Diet |
| Control group | No intervention | Participants would be required to maintain existing diet patterns and physical activity levels. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Body weight
Body weight change of participants
Measured: Baseline (1-2 days before the intervention), right after intervention (12 weeks)
Secondary outcomes (21)
Body fat percentage
Body fat percentage were measured by body composition analyzers.
Measured: Baseline (1-2 days before the intervention), right after intervention (12 weeks)
Fat mass
Fat mass (in kg) were measured by body composition analyzers.
Measured: Baseline (1-2 days before the intervention), right after intervention (12 weeks)
Systolic and diastolic blood pressure
Sitting systolic and diastolic blood pressure were measured with a validated electronic blood pressure monitor (model OMRON,HEM-7124).
Measured: Baseline (1-2 days before the intervention), right after intervention (12 weeks)
Serum lipid levels
Serum lipid levels (total cholesterol, low-density lipoprotein cholesterol, high-density lipoprotein cholesterol, triglycerides) were analyzed by the enzymatic method.
Measured: Baseline (1-2 days before the intervention), right after intervention (12 weeks)
Fasting plasma glucose
Fasting plasma glucose were analyzed by the glucose oxidase method.
Measured: Baseline (1-2 days before the intervention), right after intervention (12 weeks)
Fasting plasma insulin
Fasting plasma glucose were analyzed by the electrochemiluminescence method.
Measured: Baseline (1-2 days before the intervention), right after intervention (12 weeks)
Intestinal flora
To measure the change of intestinal flora by analyzing feces genome 16S rDNA.
Measured: 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)
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.
Measured: Baseline (1-2 days before the intervention), right after intervention (12 weeks)
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.
Measured: Baseline (1-2 days before the intervention), right after intervention (12 weeks)
High-Sensitivity C-Reactive Protein (hs-CRP)
The levels of the serum hs-CRP were analyzed using the Luminex Human Magnetic Assay kit.
Measured: Baseline (1-2 days before the intervention), right after intervention (12 weeks)
Intercellular adhesion molecule-1 (ICAM-1)
The levels of the serum ICAM-1 were analyzed using the Luminex Human Magnetic Assay kit.
Measured: Baseline (1-2 days before the intervention), right after intervention (12 weeks)
Tumor necrosis factor alpha (TNF-alpha)
The levels of the serum TNF-alpha were analyzed using the Luminex Human Magnetic Assay kit.
Measured: Baseline (1-2 days before the intervention), right after intervention (12 weeks)
Chemokine CCL2
The levels of the serum chemokine CCL2 were analyzed using the Luminex Human Magnetic Assay kit.
Measured: Baseline (1-2 days before the intervention), right after intervention (12 weeks)
Vascular cell adhesion molecule (VCAM-1)
The levels of the serum VCAM-1 were analyzed using the Luminex Human Magnetic Assay kit.
Measured: Baseline (1-2 days before the intervention), right after intervention (12 weeks)
Interleukin-6 (IL-6)
The levels of the serum IL-6 were analyzed using the Luminex Human Magnetic Assay kit.
Measured: Baseline (1-2 days before the intervention), right after intervention (12 weeks)
Interleukin-8 (IL-8)
The levels of the IL-8 were analyzed using the Luminex Human Magnetic Assay kit.
Measured: Baseline (1-2 days before the intervention), right after intervention (12 weeks)
Leptin
The levels of the serum leptin were analyzed using the Luminex Human Magnetic Assay kit.
Measured: Baseline (1-2 days before the intervention), right after intervention (12 weeks)
Tau protein
The levels of the serum tau protein were analyzed using the Luminex Human Magnetic Assay kit.
Measured: Baseline (1-2 days before the intervention), right after intervention (12 weeks)
Brain-derived neurotrophic factor (BDNF)
The levels of the serum BDNF were analyzed using the Luminex Human Magnetic Assay kit.
Measured: Baseline (1-2 days before the intervention), right after intervention (12 weeks)
Vascular endothelial growth factor (VEGF)
The levels of the serum VEGF were analyzed using the Luminex Human Magnetic Assay kit.
Measured: Baseline (1-2 days before the intervention), right after intervention (12 weeks)
Circulating metabolome
To measure the change of circulating metabolome by LC-MS/MS method.
Measured: Baseline (1-2 days before the intervention), right after intervention (12 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2021
- Study start2 Apr 2021
- Primary completion31 Dec 2022 (estimated)
- Study completion28 Feb 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Cardiometabolic RiskStudies of the same condition, open and under way.
- More trials run by Sun Yat-sen UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yanna Zhu, Sun Yat-sen University
- Investigators
- Yanna Zhu, M.D, Principal investigator, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04834687
- Sponsor's protocol ID
- ZDGW[2021]044
- Status last verified
- Sep 2021
- First submitted
- 3 Apr 2021
- Last updated
- 22 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 39802638Zhu L, Ming Y, Wu M, Zhang X, Wang X, Li H, Lin Z, Gao F, Zhu Y. Effect of Fiber-Rich Diet and Rope Skipping on Memory, Executive Function, and Gut Microbiota in Young Adults: A Randomized Controlled Trial. Mol Nutr Food Res. 2024 Feb;68(3):e2300673. doi: 10.1002/mnfr.202300673. Epub 2023 Dec 10.
PubMed 38072647Lin 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.
PubMed 37803759
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Diet and Exercise Interventions on Cardiometabolic Risk Markers, Executive Function, and Intestinal Flora in Undergraduate Students: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04834687
- Acronym / sponsor ID
- ZDGW[2021]044
- Keywords
- Dietary Fiber, Time Restricted Feeding, Exercise, Young Adult
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- 2 Apr 2021 (actual)
- Primary completion
- 31 Dec 2022 (estimated)
- Study completion
- 28 Feb 2023 (estimated)
- First posted
- 8 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Rope-skipping group | Experimental | Behavioral: ExerciseParticipants would be required to take part in an exercise plan, under the instruction and guidance of professional sports teachers. |
| Diet intervention group | Experimental | Behavioral: DietParticipants would be required to take part in a diet plan , including a high-fiber diet and time-restricted eating. |
| Combined intervention group | Experimental | Behavioral: Exercise, Behavioral: DietParticipants will receive both rope-skipping and diet interventions at the same time. |
| Control group | No intervention | –Participants would be required to maintain existing diet patterns and physical activity levels. |
Who may qualify
- Ages
- 17 to 24 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ExerciseRope-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. | Behavioural | Combined intervention group, Rope-skipping group |
| DietDiet 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 . | Behavioural | Combined intervention group, Diet intervention group |
Primary outcome
Body weight
Time frame: Baseline (1-2 days before the intervention), right after intervention (12 weeks)
Body weight change of participants
21 secondary outcomes
Body fat percentage
Time frame: 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)
Systolic and diastolic blood pressure
Time frame: 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)
Fasting plasma glucose
Time frame: 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)
Intestinal flora
Time frame: 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)
Change in appetite sensations
Time frame: 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)
Intercellular adhesion molecule-1 (ICAM-1)
Time frame: 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)
Chemokine CCL2
Time frame: 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)
Interleukin-6 (IL-6)
Time frame: 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)
Leptin
Time frame: 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)
Brain-derived neurotrophic factor (BDNF)
Time frame: 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)
Circulating metabolome
Time frame: Baseline (1-2 days before the intervention), right after intervention (12 weeks)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2021.
- Derived from this study: PubMed 39802638Lin 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.
- Derived from this study: PubMed 38072647Zhu L, Ming Y, Wu M, Zhang X, Wang X, Li H, Lin Z, Gao F, Zhu Y. Effect of Fiber-Rich Diet and Rope Skipping on Memory, Executive Function, and Gut Microbiota in Young Adults: A Randomized Controlled Trial. Mol Nutr Food Res. 2024 Feb;68(3):e2300673. doi: 10.1002/mnfr.202300673. Epub 2023 Dec 10.
- Derived from this study: PubMed 37803759Lin 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yanna Zhu, M.D principal investigator
Sun Yat-sen University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise and Diet in people with Cardiometabolic Risk and Executive Function, run by Sun Yat-sen University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yanna Zhu, M.D (86-20-87330663, zhuyn3@mail.sysu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Body weight (time frame: Baseline (1-2 days before the intervention), right after intervention (12 weeks)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04834687, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Sep 2021.