NCT04768725

Combined Physical-cognitive Exercise and Dietary Intervention for Postmenopausal Obese Women

A Randomized Controlled Trial Investigating the Effects of Combined Physical-cognitive Exercise and Dietary Intervention on Cognitive Performance and Changes in Blood Biomarkers of Postmenopausal Obese Women

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 92 (actual)
• Sponsor: Chiang Mai University · Academic / Other
• Sex: Female
• Age: 45 Years – 59 Years
• Healthy volunteers: Not accepted

Summary

This study aims to examine the effects of dietary intervention combined with physical-cognitive exergaming on cognitive performance and circulating biomarkers of obese postmenopausal women. It is hypothesized that participants will demonstrate significant improvement in cognitive performance and circulating biomarkers after participating in this combined program compared to baseline and the dietary and control groups.

Detailed description

An association between obesity and cognitive impairment has been consistently reported. The risk of having dementia in later life is about 74% higher for middle-aged obese individuals than those with normal BMI. Estrogen deprivation has also been found to impair cognition. Thus, obese postmenopausal women are likely to be at risk of having cognitive impairment. The common recommendation for obesity management is dietary and exercise intervention. Research evidence has demonstrated that either dietary intervention or moderate-vigorous intensity exercise enhance cognitive function in obese adults. This study aims to examine the effects of 12-week home-based dietary intervention combined with physical-cognitive exergaming on cognitive performance and circulating biomarkers of obese postmenopausal women through a randomised controlled trial. Participants will be randomly assigned to one of the four groups: 1) dietary intervention 2) combined physical-cognitive exergaming, 3) dietary intervention combined with physical-cognitive exergaming, and 4) control group. Outcome measures including cognitive performance (i.e. executive function, episodic memory, attention, language, and global cognition), circulating biomarkers (i.e. BDNF level, metabolic parameters, inflammation markers, and adiponectin levels) as well as physical performance will be determined at baseline and after 12-week intervention. Findings from this study may offer a feasible and effective intervention program to improve cognitive performance along with its responsible circulating biomarkers in obese postmenopausal women.

Conditions

• Obesity

Interventions

Type	Name	Description
BEHAVIORAL	Dietary intervention combined with physical-cognitive exergaming	Intermittent Fasting (IF) \[self-selected diet with 25-75% of estimated baseline energy requirements for 2 days/week (fast day) along with ad libitum for 5 days/week (feed day)\] combined with physical-cognitive exercise \[60-70% of heart rate maximum for aerobic and 60-70% of 1 repetition maximum, 8-12 repetitions/set, 3 sets of each exercise for resistance exercise; memory, attention, and executive function for cognition\], 60 minutes per session, 3 sessions per week for 12 weeks (36 sessions)\].
BEHAVIORAL	Dietary intervention	Intermittent Fasting (IF) \[self-selected diet with 25-75% of estimated baseline energy requirements for 2 days/week (fast day) along with ad libitum for 5 days/week (feed day)\].
BEHAVIORAL	Physical-cognitive intervention	Physical-cognitive exercise \[60-70% of heart rate maximum for aerobic and 60-70% of 1 repetition maximum, 8-12 repetitions/set, 3 sets of each exercise for resistance exercise; memory, attention, and executive function for cognition\], 60 minutes per session, 3 sessions per week for 12 weeks (36 sessions)\].

Timeline

• Start date: 2021-09-26
• Primary completion: 2022-12-03
• Completion: 2022-12-05
• First posted: 2021-02-24
• Last updated: 2023-02-14

Locations

1 site across 1 country: Thailand