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

NCT04275440 | Completed

• 1 other identifier: ZDGW[2019]127
• Study Type: interventional
• Target: 195
• Locations: 1 country
• Sites: 1

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.

Conditions

Cardiometabolic Risk; Weight Loss; Immune System; Intestinal Microbiome

Keywords

Caloric Restriction; Exercise; Young Adult

Outcome Measures

Primary Outcomes (1)

• Body weight

  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 Outcomes (8)

• Body composition

  Baseline (1-2 days before the intervention), right after intervention (8 weeks), 8 weeks after completion of the intervention

• Serum lipid levels

  Baseline (1-2 days before the intervention), right after intervention (8 weeks), 8 weeks after completion of the intervention

• Fasting plasma glucose

  Baseline (1-2 days before the intervention), right after intervention (8 weeks), 8 weeks after completion of the intervention

• Systolic and diastolic blood pressure

  Baseline (1-2 days before the intervention), right after intervention (8 weeks), 8 weeks after completion of the intervention

• Immune inflammation indicators

  Baseline (1-2 days before the intervention), right after intervention (8 weeks), 8 weeks after completion of the intervention

Study Arms (3)

Exercise group

EXPERIMENTAL

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

Behavioral: Exercise

Caloric restriction group

EXPERIMENTAL

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

Behavioral: Caloric restriction

Combined intervention group

EXPERIMENTAL

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

Behavioral: Exercise; Behavioral: Caloric restriction

Interventions

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.

Combined intervention group; Exercise group

Caloric restriction 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).

Caloric restriction group; Combined intervention group

Eligibility Criteria

• Age: 18 Years - 24 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sun Yat-sen University: lead

Study Sites (1)

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

Location

MeSH Terms

Conditions

Weight Loss; Motor Activity

Interventions

Exercise; Caloric Restriction

Condition Hierarchy (Ancestors)

Body Weight Changes; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Diet Therapy; Nutrition Therapy; Therapeutics; Energy Intake; Diet; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Study Officials

• Yanna Zhu, M.D

  Sun Yat-sen University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: February 12, 2020
• First Posted: February 19, 2020
• Study Start: December 6, 2019
• Primary Completion: April 5, 2020
• Study Completion: April 12, 2020
• Last Updated: September 22, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)