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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
200

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • China
    • 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:

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Rope-skipping group
Participants would be required to take part in an exercise plan, under the instruction and guidance of professional sports teachers.
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.
Experimental: Diet intervention group
Participants would be required to take part in a diet plan , including a high-fiber diet and time-restricted eating.
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 .
Experimental: Combined intervention group
Participants will receive both rope-skipping and diet interventions at the same time.
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.
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 .
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Sun Yat-sen University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 2, 2021

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2022

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 28, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 3, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 6, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 8, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 22, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 21, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2021

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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