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Effects of Caloric Restriction and Exercise on Body Weight, Immune Function, and Intestinal Flora

Primary Purpose

Cardiometabolic Risk, Weight Loss, Immune System

Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Exercise
Caloric restriction
Sponsored by
Sun Yat-sen University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Cardiometabolic Risk focused on measuring Caloric Restriction, Exercise, Young Adult

Eligibility Criteria

18 Years - 24 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  1. First and second year undergraduate students in Sun Yat-sen University.
  2. BMI≥22 kg/m2.
  3. Having the time and volunteering to receive the interventions.

Exclusion Criteria:

  1. Currently engaged in other weight-lossing studies.
  2. With secondary obesity induced by medicine or other diseases.
  3. With high blood pressure, diabetes or other cadiovascular diseases.
  4. Contraindication to exercise.

Sites / Locations

  • 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

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Exercise group

Caloric restriction group

Combined intervention group

Arm Description

Participants would be required to take part in an exercise plan, under the instruction and guidance of professional sports teachers.

The caloric restriction plan will be designed based on individual basal metabolic rate.

Participants will receive both exercise and caloric restriction intervention at the same time.

Outcomes

Primary Outcome Measures

Body weight
Body weight change of participants

Secondary Outcome Measures

Body composition
Skeletal muscle mass and fat mass were measured by body composition analyzers.
Serum lipid levels
Serum lipid levels (total cholesterol, low-density lipoprotein cholesterol, high-density lipoprotein cholesterol, triglycerides) were analyzed by the enzymatic method.
Fasting plasma glucose
Fasting plasma glucose were analyzed by the glucose oxidase method.
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.
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.
Intestinal flora
To measure the change of intestinal flora by analyzing feces genome 16S rDNA
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.
Circulating metabolome
To measure the change of circulating metabolome by LC-MS/MS method.

Full Information

First Posted
February 12, 2020
Last Updated
September 21, 2021
Sponsor
Sun Yat-sen University
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1. Study Identification

Unique Protocol Identification Number
NCT04275440
Brief Title
Effects of Caloric Restriction and Exercise on Body Weight, Immune Function, and Intestinal Flora
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
Study Type
Interventional

2. Study Status

Record Verification Date
September 2021
Overall Recruitment Status
Completed
Study Start Date
December 6, 2019 (Actual)
Primary Completion Date
April 5, 2020 (Actual)
Study Completion Date
April 12, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sun Yat-sen University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cardiometabolic Risk, Weight Loss, Immune System, Intestinal Microbiome
Keywords
Caloric Restriction, Exercise, Young Adult

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
195 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Exercise group
Arm Type
Experimental
Arm Description
Participants would be required to take part in an exercise plan, under the instruction and guidance of professional sports teachers.
Arm Title
Caloric restriction group
Arm Type
Experimental
Arm Description
The caloric restriction plan will be designed based on individual basal metabolic rate.
Arm Title
Combined intervention group
Arm Type
Experimental
Arm Description
Participants will receive both exercise and caloric restriction intervention at the same time.
Intervention Type
Behavioral
Intervention Name(s)
Exercise
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Caloric restriction
Intervention Description
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).
Primary Outcome Measure Information:
Title
Body weight
Description
Body weight change of participants
Time Frame
Baseline (1-2 days before the intervention), right after intervention (8 weeks), 8 weeks after completion of the intervention
Secondary Outcome Measure Information:
Title
Body composition
Description
Skeletal muscle mass and fat mass were measured by body composition analyzers.
Time Frame
Baseline (1-2 days before the intervention), right after intervention (8 weeks), 8 weeks after completion of the intervention
Title
Serum lipid levels
Description
Serum lipid levels (total cholesterol, low-density lipoprotein cholesterol, high-density lipoprotein cholesterol, triglycerides) were analyzed by the enzymatic method.
Time Frame
Baseline (1-2 days before the intervention), right after intervention (8 weeks), 8 weeks after completion of the intervention
Title
Fasting plasma glucose
Description
Fasting plasma glucose were analyzed by the glucose oxidase method.
Time Frame
Baseline (1-2 days before the intervention), right after intervention (8 weeks), 8 weeks after completion of the intervention
Title
Systolic and diastolic blood pressure
Description
Sitting systolic and diastolic blood pressure were measured with a validated mercury sphygmomanometer (model XJ1ID, China) and TZ-1 stethoscope.
Time Frame
Baseline (1-2 days before the intervention), right after intervention (8 weeks), 8 weeks after completion of the intervention
Title
Immune inflammation indicators
Description
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.
Time Frame
Baseline (1-2 days before the intervention), right after intervention (8 weeks), 8 weeks after completion of the intervention
Title
Intestinal flora
Description
To measure the change of intestinal flora by analyzing feces genome 16S rDNA
Time Frame
Baseline (1-2 days before the intervention), right after intervention (8 weeks), 8 weeks after completion of the intervention
Title
Change in scores on Behaviour Rating Inventory of Executive Functioning-Adult Version (BRIEF-A)
Description
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.
Time Frame
Baseline (1-2 days before the intervention), right after intervention (8 weeks), 8 weeks after completion of the intervention
Title
Circulating metabolome
Description
To measure the change of circulating metabolome by LC-MS/MS method.
Time Frame
Baseline (1-2 days before the intervention), right after intervention (8 weeks), 8 weeks after completion of the intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
24 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yanna Zhu, M.D
Organizational Affiliation
Sun Yat-sen University
Official's Role
Principal Investigator
Facility Information:
Facility Name
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
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510080
Country
China

12. IPD Sharing Statement

Plan to Share IPD
No

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Effects of Caloric Restriction and Exercise on Body Weight, Immune Function, and Intestinal Flora

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