Time Restricted Fasting and Aerobic Exercise Interventions Among Sedentary Adults

NCT05865639 | Completed

• 1 other identifier: 20230411
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

Brief Summary

This project will determine the independent and combined effects of aerobic exercise and time restricted fasting on cardiovascular risks among sedentary middle-aged and elderly adults. The online intervention period will be eight weeks. Before and after the intervention, arterial stiffness, cardiac autonomic nervous, body composition, glucolipid metabolism, sleep and eating habits, inflammatory reaction, sedentary behavior and physical activity level will be measured and compared between groups who are doing either aerobic exercise, time restricted fasting, both aerobic exercise and time restricted fasting, or who are in a control group. Adverse reaction, sleep and eating quality, life quality and adherence to the interventions and hunger/satiety will also be measured.

Conditions

Sedentary; Aging

Outcome Measures

Primary Outcomes (5)

• Change of cardiovascular risk estimated by heart rate variability

  From baseline to after 8 weeks intervention

• Change of cardiovascular risk estimated by ankle-brachial index

  From baseline to after 8 weeks intervention

• Change of cardiovascular risk estimated by pulse wave velocity

  From baseline to after 8 weeks intervention

• Change of cardiovascular risk estimated by flow-mediated transition

  From baseline to after 8 weeks intervention

• Change of cardiovascular risk estimated by cytokines level

  Fasting matrix metalloproteinases, norepinephrine, and neuropeptide Y cytokines level in blood

  From baseline to after 8 weeks intervention

Secondary Outcomes (18)

• Weight

  From baseline to after 8 weeks intervention

• body fat

  From baseline to after 8 weeks intervention

• Lean body mass

  From baseline to after 8 weeks intervention

• Body mass Index

  From baseline to after 8 weeks intervention

• Body fat percentage

  From baseline to after 8 weeks intervention

Study Arms (4)

Aerobic Exercise

EXPERIMENTAL

Aerobic exercise for eight weeks. Three weekly, supervised training sessions.

Behavioral: Aerobic Exercise

Time Restricted Fasting

EXPERIMENTAL

Time restricted fasting for eight weeks. Maximal daily eating window of 8 hours.

Behavioral: Time Restricted Fasting

Aerobic exercise & Time Restricted Fasting

EXPERIMENTAL

Behavioral: Aerobic Exercise; Behavioral: Time Restricted Fasting

Control

NO INTERVENTION

Will be given information about the recommended level of physical activity for health benefits and a healthy diet.

Interventions

Aerobic Exercise BEHAVIORAL

Three weekly, supervised exercise sessions with aerobic exercise. Each session will last for 60-65 minutes, each period will be consist of 5 min warm up, 45 min formal training and 5-10 min relaxation training. Intervention period will be eight weeks.

Aerobic Exercise; Aerobic exercise & Time Restricted Fasting

Time Restricted Fasting BEHAVIORAL

Restricted daily window of caloric intake to maximum 8 hours. Intervention period will be eight weeks.

Aerobic exercise & Time Restricted Fasting; Time Restricted Fasting

Eligibility Criteria

• Age: 45 Years - 69 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age: 45-69 years old Sedentary time ≥8 hours per day
• Irregular exercise habits
• No drugs affecting the outcome index were taken
• No history of serious diseases
• Sign the subject informed consent and agree to participate in this experiment.

You may not qualify if:

• The range of body weight change in the last three months is more than 3kg
• People taking weight-loss drugs
• Participate in other experimenters 5 months before the experiment
• Unable to adjust and follow the intervention schedule.

Sponsors & Collaborators

• Guangzhou Sport University: lead
• Guangdong Provincial Key Laboratory of Physical Activity and Health Promotion: collaborator
• Guangdong Provincial Scientific Research Center: collaborator

Study Sites (1)

Guangzhou Sport University

Guangdong, Guangzhou, 510006, China

Location

MeSH Terms

Conditions

Sedentary Behavior

Interventions

Exercise

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

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: April 13, 2023
• First Posted: May 19, 2023
• Study Start: February 1, 2022
• Primary Completion: September 1, 2022
• Study Completion: December 1, 2022
• Last Updated: May 19, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)