NCT05996042

Brief Summary

Objective: This study aims to compare the effects of a combination of time-restricted diet and multimodal aerobic exercise (calisthenics, yoga, and comprehensive physical training) on cardiovascular and metabolic health in a sedentary population with both interventions alone. Study design. Randomized controlled trial Participants: Sedentary (average sitting time greater than 6 hours per day over the past six months, and average moderate-intensity physical activity less than 125 minutes per week or vigorous-intensity physical activity less than 75 minutes per week as assessed by the International Physical Activity Questionnaire). Sample size: 81 Study grouping and intervention measures: Subjects who signed informed consent and met the inclusion/exclusion conditions were randomly divided into the following three groups according to gender stratification, with 27 participants in each group: single time-limited diet group, single multi-mode aerobic exercise (aerobics, yoga and comprehensive physical training) group, and combination of time-limited diet and multi-mode aerobic exercise group. The subjects who received the time-restricted diet intervention were allowed to eat only from 7am to 3pm on Tuesdays, Thursdays and Saturdays, and were allowed to drink pure water only during the rest of the day. The subjects who received the multi-mode aerobic exercise intervention carried out the exercise intervention from 6:00 PM to 7:00 PM on Monday, Wednesday and Friday under the unified guidance of the physical education teacher of the Medical Department. All subjects did not limit their total daily energy intake. The intervention lasted eight weeks. Outcome evaluation indicators: The main indicators of this study were body composition (body fat, muscle mass, fat-free weight, body weight, BMI, body fat percentage, total body water, protein, inorganic salts, limb muscle and extracellular water ratio).

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
81

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Aug 2023

Shorter than P25 for not_applicable

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 13, 2023

Completed
4 months until next milestone

First Posted

Study publicly available on registry

August 16, 2023

Completed
4 days until next milestone

Study Start

First participant enrolled

August 20, 2023

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 20, 2023

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 20, 2023

Completed
Last Updated

August 16, 2023

Status Verified

April 1, 2023

Enrollment Period

1 month

First QC Date

April 13, 2023

Last Update Submit

August 10, 2023

Conditions

Healthy Population

Keywords

SedentaryTime-restricted dietExercise intervention

Outcome Measures

Primary Outcomes (14)

  • Body fat

    Measurements were made using the Inbody 770, using the bioresistive method

    Baseline survey

  • Muscle mass

    Measurements were made using the Inbody 770, using the bioresistive method

    Baseline survey

  • Fat-free weight

    Measurements were made using the Inbody 770, using the bioresistive method

    Baseline survey

  • body weight

    Measurements were made using the Inbody 770, using the bioresistive method in Kg

    Baseline survey

  • body weight

    Measurements were made using the Inbody 770, using the bioresistive method in Kg

    8 weeks after baseline survey

  • Body fat percentage

    Measurements were made using the Inbody 770, using the bioresistive method in %

    Baseline survey

  • Body fat percentage

    Measurements were made using the Inbody 770, using the bioresistive method in %

    8 weeks after baseline survey

  • Body water

    Measurements were made using the Inbody 770, using the bioresistive method

    Baseline survey

  • Body water

    Measurements were made using the Inbody 770, using the bioresistive method

    8 weeks after baseline survey

  • Muscle mass

    Measurements were made using the Inbody 770, using the bioresistive method

    8 weeks after baseline survey

  • Body fat

    Measurements were made using the Inbody 770, using the bioresistive method

    8 weeks after baseline survey

  • Fat-free weight

    Measurements were made using the Inbody 770, using the bioresistive method

    8 weeks after baseline survey

  • Body mass index

    Measurements were made using the Inbody 770, measured by weight(Kg) divided by height(meter) squared

    Baseline survey

  • Body mass index

    Measurements were made using the Inbody 770, measured by weight(Kg) divided by height(meter) squared

    8 weeks after baseline survey

Secondary Outcomes (14)

  • Waist circumference

    Baseline survey

  • Waist circumference

    8 weeks after baseline survey

  • Hip circumference

    Baseline survey

  • Hip circumference

    8 weeks after baseline survey

  • Blood pressure

    Baseline survey

  • +9 more secondary outcomes

Study Arms (3)

Time-restricted diet group

OTHER

Subjects in this group were given a limited diet every Tuesday, Thursday and Saturday. They were only allowed to eat from 7am to 3pm on the same day, and only allowed to drink purified water during other periods, namely an 8-hour eating window and a 16-hour fasting period

Behavioral: Time-restricted diet

Multimode aerobics group

OTHER

Subjects in this group performed multi-mode aerobic exercise from 6:00 PM to 7:00 PM on Monday, Wednesday and Friday under the unified guidance of the physical education teacher of the Health Science Center in the gymnasium and sports field of Peking University Health Science Center, including aerobics, yoga and comprehensive physical training

Behavioral: Time-restricted diet

A combination of time-restricted diet and multimodal aerobic exercise

EXPERIMENTAL

Subjects in this group received the same time-limited dietary intervention every Tuesday, Thursday and Saturday according to the above requirements of the single time-limited dietary group, and the same multi-mode aerobic exercise intervention every Monday, Wednesday and Friday according to the above requirements of the single multi-mode aerobic exercise group.

Behavioral: Time-restricted diet

Interventions

Time-restricted dietBEHAVIORAL

On Tuesdays, Thursdays and Saturdays, only eating is allowed between 7am and 3pm. The rest of the time, only drinking pure water is allowed, which is an eight-hour eating window and a 16-hour fasting period. On Mondays, Wednesdays and Fridays, under the unified guidance of the physical education teachers of the Health Science Department from 6:00 PM to 7:00 PM, the venue is the gymnasium and sports field of Peking University Health Science Center. The exercise items include aerobics, yoga and comprehensive physical training.

Also known as: Multimodal aerobic exercise
A combination of time-restricted diet and multimodal aerobic exerciseMultimode aerobics groupTime-restricted diet group

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • In the past six months, the average daily sitting time was more than 6 hours, and the average weekly moderate-intensity physical activity time was less than 125 minutes or high-intensity physical activity time was less than 75 minutes as assessed by the International Physical Activity Questionnaire (JAMA Intern Med. 2022 Jun 1; 182(6):650-659, J Sport Health Sci. 2022 Mar; 11(2): 164 -- 171. And Global recommendations on physical activity for health);
  • BMI of 18.5-30 kg/m 2, age 18-50, where BMI= weight (kg)/height 2 (m);
  • Weight change less than 3 kg in the last six months;
  • Unlimited hours or other types of fasting, such as alternate-day fasting or simulated fasting diets;
  • No cardiovascular metabolic diseases such as hypertension, type 2 diabetes, chronic kidney disease, coronary heart disease and stroke;
  • No movement disorder related diseases, no sports injury history in the past six months.

You may not qualify if:

  • Weigh more than 100 kg;
  • Used weight-loss drugs or dietary supplements and used hormone drugs in the past six months;
  • Abnormal liver and kidney function was found by laboratory examination;
  • Women who are pregnant, lactating or planning to become pregnant in the near future;
  • Still unable to skillfully use smart phones and sports bracelets after training;
  • Other circumstances deemed unsuitable for participation in the study by the researchers

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Sedentary Behavior

Condition Hierarchy (Ancestors)

Behavior

Study Officials

  • Qihuang Gong, Dr

    Peking University

    STUDY CHAIR

Central Study Contacts

Tao Huang, Dr

CONTACT

13488745828huangtao@bjmu.edu.cn

Yimin Zhao, Dr

CONTACT

178107885032116390124@bjmu.edu.cn

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 13, 2023

First Posted

August 16, 2023

Study Start

August 20, 2023

Primary Completion

September 20, 2023

Study Completion

October 20, 2023

Last Updated

August 16, 2023

Record last verified: 2023-04

Data Sharing

IPD Sharing
Will share

The anonymous data is then shared with relevant collaborators

Shared Documents
STUDY PROTOCOL, ICF, CSR, ANALYTIC CODE
Time Frame
After the data is anonymized
Access Criteria
Need to reach an agreement and sign a collaboration agreement with the researcher