Clinical trial NCT05996042: Time-restricted Diet Combined With Multimodal Aerobic Exercise
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Healthy Population
Keywords: Sedentary
Time-restricted diet
Exercise intervention
Lead sponsor: Peking University
Sponsor class: OTHER
First posted: 2023-08-16
Enrollment: 81
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

Detailed 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).

Eligibility criteria: 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

Primary outcomes:
measure: Body fat
timeFrame: Baseline survey
measure: Muscle mass
timeFrame: Baseline survey
measure: Fat-free weight
timeFrame: Baseline survey
measure: body weight
timeFrame: Baseline survey
measure: body weight
timeFrame: 8 weeks after baseline survey
measure: Body fat percentage
timeFrame: Baseline survey
measure: Body fat percentage
timeFrame: 8 weeks after baseline survey
measure: Body water
timeFrame: Baseline survey
measure: Body water
timeFrame: 8 weeks after baseline survey
measure: Muscle mass
timeFrame: 8 weeks after baseline survey
measure: Body fat
timeFrame: 8 weeks after baseline survey
measure: Fat-free weight
timeFrame: 8 weeks after baseline survey
measure: Body mass index
timeFrame: Baseline survey
measure: Body mass index
timeFrame: 8 weeks after baseline survey
Secondary outcomes:
measure: Waist circumference
timeFrame: Baseline survey
measure: Waist circumference
timeFrame: 8 weeks after baseline survey
measure: Hip circumference
timeFrame: Baseline survey
measure: Hip circumference
timeFrame: 8 weeks after baseline survey
measure: Blood pressure
timeFrame: Baseline survey
measure: Blood pressure
timeFrame: 8 weeks after baseline survey
measure: Heart rate
timeFrame: Baseline survey
measure: Heart rate
timeFrame: 8 weeks after baseline survey
measure: Blood Lipid
timeFrame: Baseline survey
measure: Blood Lipid
timeFrame: 8 weeks after baseline survey
measure: urine routine
timeFrame: Baseline survey
measure: urine routine
timeFrame: 8 weeks after baseline survey
measure: Questionnaire survey
timeFrame: Baseline survey
measure: Questionnaire survey
timeFrame: 8 weeks after baseline survey
Other outcomes:
Locations:
Study officials:
affiliation: Peking University
name: Qihuang Gong, Dr
role: STUDY_CHAIR
References: