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

NCT ID: NCT04275440

Last Updated: 2021-09-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 195 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-12-06
• Study Completion Date: 2020-04-12

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.

Conditions

Cardiometabolic Risk; Weight Loss; Immune System; Intestinal Microbiome

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

Exercise group

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

Group Type: EXPERIMENTAL

Exercise

Intervention Type: 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 group

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

Group Type: EXPERIMENTAL

Caloric restriction

Intervention Type: BEHAVIORAL

1. 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).

Combined intervention group

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

Group Type: EXPERIMENTAL

Exercise

Intervention Type: 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

Intervention Type: BEHAVIORAL

1. 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).

Interventions

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.

Intervention Type: BEHAVIORAL

Caloric restriction

1. 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).

Intervention Type: BEHAVIORAL

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 24 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Sun Yat-sen University

OTHER

Sponsor Role: lead

Responsible Party

Yanna Zhu

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Yanna Zhu, M.D

Role: PRINCIPAL_INVESTIGATOR

Sun Yat-sen University

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

Guangzhou, Guangdong, China

Countries

China

Other Identifiers

ZDGW[2019]127

Identifier Type: -

Identifier Source: org_study_id