Time-restricted Diet Combined With Multimodal Aerobic Exercise

Healthy Population Clinical Trial

Official title:

A Randomized Controlled Trial of Time-restricted Diet Combined With Multimodal Aerobic Exercise Intervention on Cardiovascular and Metabolic Health in a Sedentary Population

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05996042
• Other study ID #: RCT of Sedentary Population
• Status: Not yet recruiting
• Phase: N/A
• Start date: August 20, 2023
• Est. completion date: October 20, 2023

Study information

• Verified date: April 2023
• Source: Peking University
• Contact: Tao Huang, Dr
• Phone: 13488745828
• Email: huangtao[@]bjmu.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Description:

Subjects who signed the informed consent and met the inclusion criteria were randomly divided into the following three groups according to gender stratification:

1. Single time-limited diet group: Subjects in this group were given a time-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. Total daily energy intake is not restricted, and food selection is recommended in accordance with the Dietary Guidelines for Chinese Residents (2022). Subjects in this group were required to maintain the original physical activity frequency;

2. Independent multi-mode aerobic exercise group: Subjects in this group will do multi-mode aerobic exercise from 6:00 PM to 7:00 PM on Mondays, Wednesdays and Fridays under the unified guidance of the physical education teacher of the Health Science Department (see Attachment 3 for details). The venue is the gymnasium and sports ground of Peking University Health Science Center, and the exercise items include aerobics, yoga and comprehensive physical training, see attachment for details. Subjects in this group do not limit their daily total energy intake, and it is recommended to choose food according to the Dietary Guidelines for Chinese Residents (2022).

3. Combined group of time-limited diet and multi-mode aerobic exercise: Subjects in this group received the same time-limited diet intervention according to the above requirements of the single-mode diet group every Tuesday, Thursday and Saturday, and the same multi-mode aerobic exercise intervention according to the above requirements of the single-mode aerobic exercise group every Monday, Wednesday and Friday. Total daily energy intake is not restricted, and food selection is recommended in accordance with the Dietary Guidelines for Chinese Residents (2022).

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 81
• Est. completion date: October 20, 2023
• Est. primary completion date: September 20, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

Inclusion Criteria:

1. 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);

2. BMI of 18.5-30 kg/m 2, age 18-50, where BMI= weight (kg)/height 2 (m);

3. Weight change less than 3 kg in the last six months;

4. Unlimited hours or other types of fasting, such as alternate-day fasting or simulated fasting diets;

5. No cardiovascular metabolic diseases such as hypertension, type 2 diabetes, chronic kidney disease, coronary heart disease and stroke;

6. No movement disorder related diseases, no sports injury history in the past six months.

Exclusion Criteria:

1. Weigh more than 100 kg;

2. Used weight-loss drugs or dietary supplements and used hormone drugs in the past six months;

3. Abnormal liver and kidney function was found by laboratory examination;

4. Women who are pregnant, lactating or planning to become pregnant in the near future;

5. Still unable to skillfully use smart phones and sports bracelets after training;

6. Other circumstances deemed unsuitable for participation in the study by the researchers

Related Conditions & MeSH terms

• Healthy Population

Intervention

Behavioral:
• Time-restricted diet
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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Peking University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Body fat	Measurements were made using the Inbody 770, using the bioresistive method	Baseline survey
Primary	Muscle mass	Measurements were made using the Inbody 770, using the bioresistive method	Baseline survey
Primary	Fat-free weight	Measurements were made using the Inbody 770, using the bioresistive method	Baseline survey
Primary	body weight	Measurements were made using the Inbody 770, using the bioresistive method in Kg	Baseline survey
Primary	body weight	Measurements were made using the Inbody 770, using the bioresistive method in Kg	8 weeks after baseline survey
Primary	Body fat percentage	Measurements were made using the Inbody 770, using the bioresistive method in %	Baseline survey
Primary	Body fat percentage	Measurements were made using the Inbody 770, using the bioresistive method in %	8 weeks after baseline survey
Primary	Body water	Measurements were made using the Inbody 770, using the bioresistive method	Baseline survey
Primary	Body water	Measurements were made using the Inbody 770, using the bioresistive method	8 weeks after baseline survey
Primary	Muscle mass	Measurements were made using the Inbody 770, using the bioresistive method	8 weeks after baseline survey
Primary	Body fat	Measurements were made using the Inbody 770, using the bioresistive method	8 weeks after baseline survey
Primary	Fat-free weight	Measurements were made using the Inbody 770, using the bioresistive method	8 weeks after baseline survey
Primary	Body mass index	Measurements were made using the Inbody 770, measured by weight(Kg) divided by height(meter) squared	Baseline survey
Primary	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	Waist circumference	The measurements are made by a professional using a tape measure	Baseline survey
Secondary	Waist circumference	The measurements are made by a professional using a tape measure	8 weeks after baseline survey
Secondary	Hip circumference	The measurements are made by a professional using a tape measure	Baseline survey
Secondary	Hip circumference	The measurements are made by a professional using a tape measure	8 weeks after baseline survey
Secondary	Blood pressure	The measurement was carried out using an electronic sphygmomanometer, and the average value was measured three times in the resting state	Baseline survey
Secondary	Blood pressure	The measurement was carried out using an electronic sphygmomanometer, and the average value was measured three times in the resting state	8 weeks after baseline survey
Secondary	Heart rate	The heart rate band was used for measurement, and the resting state was measured three times to take the average value	Baseline survey
Secondary	Heart rate	The heart rate band was used for measurement, and the resting state was measured three times to take the average value	8 weeks after baseline survey
Secondary	Blood Lipid	Fasting blood lipid (TC, TG, HDL-C, LDL-C),Blood is drawn by a trained nurse and blood biochemical tests are performed	Baseline survey
Secondary	Blood Lipid	Including TC, TG, HDL-C, LDL-C ,blood is drawn by a trained nurse and blood biochemical tests are performed	8 weeks after baseline survey
Secondary	urine routine	Including urinary protein, urinary creatinine, urine collection was followed by routine urine testing at the hospital	Baseline survey
Secondary	urine routine	Including urinary protein, urinary creatinine, urine collection was followed by routine urine testing at the hospital	8 weeks after baseline survey
Secondary	Questionnaire survey	Demographic characteristics questionnaire, 4-day 24-hour dietary review, international physical activity questionnaire, sleep quality questionnaire, CNAQ appetite questionnaire	Baseline survey
Secondary	Questionnaire survey	Demographic characteristics questionnaire, 4-day 24-hour dietary review, international physical activity questionnaire, sleep quality questionnaire, CNAQ appetite questionnaire	8 weeks after baseline survey