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
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Chiang Mai University
- Enrollment
- 92
- Locations
- 1
- Primary Endpoint
- change from baseline time to complete Trail Making B-A at 12 weeks
Study Overview
Brief 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Other
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 45 Years to 59 Years (Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •obese women (body mass index (BMI) ≥ 25 kg/m2 with waist-to-hip ratio (WHR) ≥ 0.80)
- •post-menopausal (self-reported menstrual characteristics (last menstruation > 1 year) or confirmed by blood follicular stimulating hormone (FSH) level ( > 20 IU/L) and estradiol level ( ≤ 30 pg/ml))
- •sedentary lifestyle (exercise < 1 hr./wk.)
- •normal range of the Mental State Examination T10 (MSET10) score
- •at least 6 years of education
- •own a mobile phone that supports application platform
- •able to comply with the study schedule and procedures
Exclusion Criteria
- •have medical conditions that would be unsafe to exercise or have been diagnosed with neurological conditions (e.g. Parkinson's disease, stroke, multiple sclerosis) that affect cognition and mobility
- •have weight variation ( > 5 kilogram in 3 months)
- •have other dietary restrictions (e.g. vegetarianism and veganism)
- •have depressive symptoms defined as a score ≥ 11 on Hospital Anxiety Depression Scale (HADS)
- •have an uncorrected visual or hearing impairment
- •receive hormonal replacement therapy
Arms & Interventions
Dietary intervention
Participants will consume a 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).
Intervention: Dietary intervention (Behavioral)
Physical-cognitive intervention
Participants will perform home-based physical-cognitive training for 60 minutes per session, 3 session a week.
Intervention: Physical-cognitive intervention (Behavioral)
Physical-cognitive with dietary intervention
Participants will receive both dietary intervention and physical-cognitive training same as those in the dietary and physical-cognitive intervention groups.
Intervention: Dietary intervention combined with physical-cognitive exergaming (Behavioral)
Control
Participants in the control group will be encouraged to continue their activities and calorie intakes as they usually would.
Outcomes
Primary Outcomes
change from baseline time to complete Trail Making B-A at 12 weeks
Time Frame: 12 weeks
Time to complete Trail Making B and A will be recorded in seconds. The difference between time to complete Trail B and A will be used to index the task switching ability, a subdomain of executive function. Smaller differences between B-A indicate better switching ability.
change from baseline Stroop Color and Word score at 12 weeks
Time Frame: 12 weeks
In Stroop Color and Word test, the number of items correctly identified in 45 seconds in each condition (i.e. word, color, color-word) will be recorded. Then the predicted score will be calculated. Score will be obtained from the different between the color-word and predicted scores. Lower scores indicate greater difficulty in inhibiting interference.
change from baseline Logical Memory score at 12 weeks
Time Frame: 12 weeks
In Logical Memory test, participants will be instructed to listen carefully to two stories and remember their contents. After a 30-delay, they will be asked to freely recall the passages (recall) and respond yes or no to the given questions (recognition). The possible scores are 0-75. Higher scores indicate better episodic memory.
change from baseline Brain-derived neurotrophic factor (BDNF) level at 12 weeks
Time Frame: 12 weeks
Level of plasma BDNF will be determined before and after the intervention.
Secondary Outcomes
- change from baseline Montreal Cognitive Assessment (MoCA) score at 12 weeks(12 weeks)
- change from baseline Digit Span score at 12 weeks(12 weeks)
- change from baseline Six-minute walk distance at 12 weeks(12 weeks)
- change from baseline Verbal Fluency score at 12 weeks(12 weeks)
- change from baseline plasma Interleukin 6 (IL-6) levels at 12 weeks(12 weeks)
- change from baseline 30 seconds Chair Stand Test at 12 weeks(12 weeks)
- change from baseline plasma adiponectin levels at 12 weeks(12 weeks)
- change from baseline insulin resistance levels at 12 weeks(12 weeks)
Investigators
Somporn Sungkarat
Associate Professor
Chiang Mai University