Cardiometabolic RiskNCT04275440
Effects of Caloric Restriction and Exercise on Body Weight, Immune Function, and Intestinal Flora
A study testing Exercise and Caloric restriction in people with Cardiometabolic Risk and Weight Loss, run by Sun Yat-sen University at 1 site in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 24 yearsHealthy volunteers can take part
- Conditions the study is for
- Cardiometabolic Risk, Weight Loss, Immune System
- What is being tested?
- Exercise and Caloric restriction
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 195 participants
- Where
- 1 siteChina
- Study dates
- 6 Dec 2019to 12 Apr 2020
- 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 18 to 24 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- First and second year undergraduate students in Sun Yat-sen University.
- BMI≥22 kg/m2.
- Having the time and volunteering to receive the interventions.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site
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
Guangzhou, Guangdong, 510080
About this study
Official title: 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.
Read the 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.
- Being tested
- Exercise, Caloric restriction
- Keywords
- Caloric Restriction, Exercise, Young Adult
- Medical subject headings
- Weight Loss, 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.
Caloric restrictionBehavioural
- In the first two weeks, participants would reduce their daily energy intake to 100% -110% of his or her basal metabolic energy under instruction, and stick to it till the end of the intervention.
- According to the dietary recommendation proposed by Chinese government, participants are required to take in cereals, vegetables, fruits, meat and eggs, while minimize the consumption of sugar-sweeten beverages.
- Participants are instructed to arrange their three meals according to the recommended energy distribution (3:4:3).
| Study group | Role | What they receive |
|---|---|---|
| Exercise 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 |
| Caloric restriction group | Experimental | The caloric restriction plan will be designed based on individual basal metabolic rate. Receives: Behavioral: Caloric restriction |
| Combined intervention group | Experimental | Participants will receive both exercise and caloric restriction intervention at the same time. Receives: Behavioral: Exercise; Behavioral: Caloric restriction |
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 (8 weeks), 8 weeks after completion of the intervention
Secondary outcomes (8)
Body composition
Skeletal muscle mass and fat mass were measured by body composition analyzers.
Measured: Baseline (1-2 days before the intervention), right after intervention (8 weeks), 8 weeks after completion of the intervention
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 (8 weeks), 8 weeks after completion of the intervention
Fasting plasma glucose
Fasting plasma glucose were analyzed by the glucose oxidase method.
Measured: Baseline (1-2 days before the intervention), right after intervention (8 weeks), 8 weeks after completion of the intervention
Systolic and diastolic blood pressure
Sitting systolic and diastolic blood pressure were measured with a validated mercury sphygmomanometer (model XJ1ID, China) and TZ-1 stethoscope.
Measured: Baseline (1-2 days before the intervention), right after intervention (8 weeks), 8 weeks after completion of the intervention
Immune inflammation indicators
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.
Measured: Baseline (1-2 days before the intervention), right after intervention (8 weeks), 8 weeks after completion of the intervention
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 (8 weeks), 8 weeks after completion of the intervention
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 (8 weeks), 8 weeks after completion of the intervention
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 (8 weeks), 8 weeks after completion of the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2020
- Study start6 Dec 2019
- Primary completion5 Apr 2020
- Study completion12 Apr 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- 195 participants (actual)
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
- NCT04275440
- Sponsor's protocol ID
- ZDGW[2019]127
- Status last verified
- Sep 2021
- First submitted
- 12 Feb 2020
- Last updated
- 22 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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 Caloric Restriction and Exercise on Body Weight, Cardiometabolic Risk Markers, Immune Function, and Intestinal Flora in College Students: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04275440
- Acronym / sponsor ID
- ZDGW[2019]127
- Keywords
- Caloric Restriction, Exercise, Young Adult
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 195 participants (actual)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- 6 Dec 2019 (actual)
- Primary completion
- 5 Apr 2020 (actual)
- Study completion
- 12 Apr 2020 (actual)
- First posted
- 19 Feb 2020 (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 caloric restriction and exercise on body weight, cardiovascular metabolic markers, immune function, and intestinal flora among college students, as well as the underlying mechanisms.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Exercise group | Experimental | Behavioral: ExerciseParticipants would be required to take part in an exercise plan, under the instruction and guidance of professional sports teachers. |
| Caloric restriction group | Experimental | Behavioral: Caloric restrictionThe caloric restriction plan will be designed based on individual basal metabolic rate. |
| Combined intervention group | Experimental | Behavioral: Exercise, Behavioral: Caloric restrictionParticipants will receive both exercise and caloric restriction intervention at the same time. |
Who may qualify
- Ages
- 18 to 24 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- First and second year undergraduate students in Sun Yat-sen University.
- BMI≥22 kg/m2.
- Having the time and volunteering to receive the interventions.
Key exclusion criteria (4 listed)
- 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.
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, Exercise group |
| Caloric restriction1. In the first two weeks, participants would reduce their daily energy intake to 100% -110% of his or her basal metabolic energy under instruction, and stick to it till the end of the intervention. 2. According to the dietary recommendation proposed by Chinese government, participants are required to take in cereals, vegetables, fruits, meat and eggs, while minimize the consumption of sugar-sweeten beverages. 3. Participants are instructed to arrange their three meals according to the recommended energy distribution (3:4:3). | Behavioural | Caloric restriction group, Combined intervention group |
Primary outcome
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
8 secondary outcomes
Body composition
Time frame: 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
Fasting plasma glucose
Time frame: 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
Immune inflammation indicators
Time frame: 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
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
Circulating metabolome
Time frame: Baseline (1-2 days before the intervention), right after intervention (8 weeks), 8 weeks after completion of the intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2021.
- Individual participant dataSharing planned: No
Related trials for Cardiometabolic Risk
Recruiting
Exercise to Improve Heart and Metabolic Health After Childbirth in Women at High Risk for Preeclampsia
Postpartum Exercise, Cardiometabolic Health
Not yet recruitingObservational study
A Natural History of Cardiometabolic Disease Among US Bhutanese: Developing the Cross-Sectional Bhutanese Community of Central Ohio Health Study to Understand Acculturation as Synergizing Socioenvironmental and Biobehavioral Risk Factors Propagating ...
Cardiometabolic Risk Factors, Mental Health
Recruiting
Improving Sleep Health and Circadian Timing to Support Cardiometabolic Health in Adolescents
Overweight Adolescents, Sleep
RecruitingObservational study
Asprosin and miRNA Expression in Young Women With Metabolic Syndrome
Metabolic Syndrome, Insulin Resistance
Not yet recruiting
Multimodal AI-Driven Out-of-Hospital Management for Hypertension and Cardiometabolic Risk
Hypertension, Hyperglycemia
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 Caloric restriction in people with Cardiometabolic Risk and Weight Loss, 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 3 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: finished, 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. 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 (8 weeks), 8 weeks after completion of the intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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.