Clinical trial NCT04768725: Combined Physical-cognitive Exercise and Dietary Intervention for Postmenopausal Obese Women
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Keywords: Dietary intervention
Cognitive function
Brain-derived neurotrophic factor
Exergaming
Obesity
Lead sponsor: Chiang Mai University
Sponsor class: OTHER
First posted: 2021-02-24
Enrollment: 92
Sex: FEMALE
Minimum age (years): 45
Maximum age (years): 59
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

Eligibility criteria: 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

Primary outcomes:
measure: change from baseline time to complete Trail Making B-A at 12 weeks
timeFrame: 12 weeks
measure: change from baseline Stroop Color and Word score at 12 weeks
timeFrame: 12 weeks
measure: change from baseline Logical Memory score at 12 weeks
timeFrame: 12 weeks
measure: change from baseline Brain-derived neurotrophic factor (BDNF) level at 12 weeks
timeFrame: 12 weeks
Secondary outcomes:
measure: change from baseline Montreal Cognitive Assessment (MoCA) score at 12 weeks
timeFrame: 12 weeks
measure: change from baseline Verbal Fluency score at 12 weeks
timeFrame: 12 weeks
measure: change from baseline Digit Span score at 12 weeks
timeFrame: 12 weeks
measure: change from baseline plasma adiponectin levels at 12 weeks
timeFrame: 12 weeks
measure: change from baseline plasma Interleukin 6 (IL-6) levels at 12 weeks
timeFrame: 12 weeks
measure: change from baseline insulin resistance levels at 12 weeks
timeFrame: 12 weeks
measure: change from baseline Six-minute walk distance at 12 weeks
timeFrame: 12 weeks
measure: change from baseline 30 seconds Chair Stand Test at 12 weeks
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Chiang Mai
country: Thailand
facility: Department of Physical Therapy, Faculty of Associated Medical Sciences, Chiang Mai University
Study officials:
affiliation: Chiang Mai University
name: Somporn Sungkarat, PhD
role: PRINCIPAL_INVESTIGATOR
References: