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Completed

NCT Number: NCT04275440

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

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.

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Key information

Conditions

Cardiometabolic Risk Behavior Body Weight Body Weight Changes Immune System Intestinal Microbiome Motor Activity Pathological Conditions, Signs and Symptoms Signs and Symptoms Weight Loss

Age range

18 year–24 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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, China

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Exercise

Behavioral

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 restriction

Behavioral
  • 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 outcomes

  1. 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

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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

  7. 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.

  8. Circulating metabolome

    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 circulating metabolome by LC-MS/MS method.

Sponsors and collaborators

Lead sponsor

Sun Yat-sen University

Other

Registry information

Official study 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

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Feb 19, 2020
Registry last updated
Sep 22, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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