- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04275440
Effects of Caloric Restriction and Exercise on Body Weight, Immune Function, and Intestinal Flora
September 21, 2021 updated by: Yanna Zhu, Sun Yat-sen University
Effects of Caloric Restriction and Exercise on Body Weight, Cardiometabolic Risk Markers, Immune Function, and Intestinal Flora in College Students: a Randomized Controlled Trial
The purpose of this study is to estimate the effects of caloric restriction and exercise on body weight, cardiovascular metabolic markers, immune function, and intestinal flora among college students, as well as the underlying mechanisms.
Study Overview
Status
Completed
Intervention / Treatment
Detailed Description
In recent decades, carbohydrate-centered food pattern has brought worrying negative effects on human health, including increasing incidence of overweight, obesity, and cardiovascular diseases.
Animal experiments based on rhesus monkey showed that caloric restriction could prolong their healthy life years, while reports from population-based studies are quite inconclusive.
There are some studies reporting that caloric restriction did reduce the risk of cardiovascular disease in those with obesity, while some other cohort studies found that not eating breakfast might increase the risk of coronary heart disease, diabetes and other related diseases.
In addition, a number of studies claimed that continuous caloric restriction is associated with the depletion of peripheral immune cells, immune suppression and reduced bone mineral density.
In spite of those inconclusive results, on the whole, fasting and caloric restriction in some way do improve the conditions of metabolism, overweight and obesity.
Previous studies mostly focused on middle-aged and elderly people, while recent studies in mice show that energy limitation in elderly people could not stop the aging process genetically or metabolically.
Therefore, this study aims to estimate the effects of caloric restriction and exercise on body weight, cardiovascular metabolic markers, immune function, and intestinal flora among college students, as well as the underlying mechanisms.
A pilot study containing around 40 participants will be conducted firstly to assess the feasibility of this intervention plan.
Study Type
Interventional
Enrollment (Actual)
195
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 Locations
-
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Guangdong
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Guangzhou, Guangdong, China, 510080
- Department of Maternal and Child Health and Sun Yat-sen Global Health Institute, School of Public Health and Institute of State Governance, Sun Yat-sen University
-
-
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
18 years to 24 years (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/m2.
- Having the time and volunteering to receive the interventions.
Exclusion Criteria:
- Currently engaged in other weight-lossing studies.
- With secondary obesity induced by medicine or other diseases.
- With high blood pressure, diabetes or other cadiovascular 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: Exercise 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: Caloric restriction group
The caloric restriction plan will be designed based on individual basal metabolic rate.
|
|
Experimental: Combined intervention group
Participants will receive both exercise and caloric restriction intervention 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.
|
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 (8 weeks), 8 weeks after completion of the intervention
|
Body weight change of participants
|
Baseline (1-2 days before the intervention), right after intervention (8 weeks), 8 weeks after completion of the intervention
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Body composition
Time Frame: Baseline (1-2 days before the intervention), right after intervention (8 weeks), 8 weeks after completion of the intervention
|
Skeletal muscle mass and fat mass were measured by body composition analyzers.
|
Baseline (1-2 days before the intervention), right after intervention (8 weeks), 8 weeks after completion of the intervention
|
Serum lipid levels
Time Frame: Baseline (1-2 days before the intervention), right after intervention (8 weeks), 8 weeks after completion of the intervention
|
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 (8 weeks), 8 weeks after completion of the intervention
|
Fasting plasma glucose
Time Frame: Baseline (1-2 days before the intervention), right after intervention (8 weeks), 8 weeks after completion of the intervention
|
Fasting plasma glucose were analyzed by the glucose oxidase method.
|
Baseline (1-2 days before the intervention), right after intervention (8 weeks), 8 weeks after completion of the intervention
|
Systolic and diastolic blood pressure
Time Frame: Baseline (1-2 days before the intervention), right after intervention (8 weeks), 8 weeks after completion of the intervention
|
Sitting systolic and diastolic blood pressure were measured with a validated mercury sphygmomanometer (model XJ1ID, China) and TZ-1 stethoscope.
|
Baseline (1-2 days before the intervention), right after intervention (8 weeks), 8 weeks after completion of the intervention
|
Immune inflammation indicators
Time Frame: Baseline (1-2 days before the intervention), right after intervention (8 weeks), 8 weeks after completion of the intervention
|
Immune and inflammatory indicators (ICAM-1, CCL2, VCAM-1, IL-6, IL-8, TNF-alpha, Leptin, Tau, BDNF, VEGF) were analyzed using the Luminex Human Magnetic Assay kit.
|
Baseline (1-2 days before the intervention), right after intervention (8 weeks), 8 weeks after completion of the intervention
|
Intestinal flora
Time Frame: Baseline (1-2 days before the intervention), right after intervention (8 weeks), 8 weeks after completion of the intervention
|
To measure the change of intestinal flora by analyzing feces genome 16S rDNA
|
Baseline (1-2 days before the intervention), right after intervention (8 weeks), 8 weeks after completion of the intervention
|
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 (8 weeks), 8 weeks after completion of the intervention
|
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.
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Baseline (1-2 days before the intervention), right after intervention (8 weeks), 8 weeks after completion of the intervention
|
Circulating metabolome
Time Frame: Baseline (1-2 days before the intervention), right after intervention (8 weeks), 8 weeks after completion of the intervention
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To measure the change of circulating metabolome by LC-MS/MS method.
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Baseline (1-2 days before the intervention), right after intervention (8 weeks), 8 weeks after completion of the intervention
|
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)
December 6, 2019
Primary Completion (Actual)
April 5, 2020
Study Completion (Actual)
April 12, 2020
Study Registration Dates
First Submitted
February 12, 2020
First Submitted That Met QC Criteria
February 16, 2020
First Posted (Actual)
February 19, 2020
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
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- ZDGW[2019]127
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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