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NCT Number: NCT04768725

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

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.

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Key information

Conditions

Obesity Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

45 year–59 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Department of Physical Therapy, Faculty of Associated Medical Sciences, Chiang Mai University

Chiang Mai, 50200, Thailand

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Dietary intervention combined with physical-cognitive exergaming

Behavioral

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)].

Dietary intervention

Behavioral

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)].

Physical-cognitive intervention

Behavioral

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)].

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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

  1. change from baseline Montreal Cognitive Assessment (MoCA) score at 12 weeks

    Time frame: 12 weeks

    The Montreal Cognitive Assessment will be used to index global cognitive function. The possible scores are 0-30. Higher scores indicate better cognitive function.

  2. change from baseline Verbal Fluency score at 12 weeks

    Time frame: 12 weeks

    Category fluency subtest (naming test) of Verbal Fluency will be used. Participants will be asked to produce as many words as possible in 60 seconds. Higher scores indicate better language ability.

  3. change from baseline Digit Span score at 12 weeks

    Time frame: 12 weeks

    In Digit Span test, lists of numbers will be presented orally to participants. They are asked to repeat the numbers immediately in ascending (forward) or reverse (backward) numerical order. The possible scores are 0-28. Higher scores indicate better attention.

  4. change from baseline plasma adiponectin levels at 12 weeks

    Time frame: 12 weeks

    Level of plasma adiponectin will be determined before and after intervention.

  5. change from baseline plasma Interleukin 6 (IL-6) levels at 12 weeks

    Time frame: 12 weeks

    Level of plasma IL-6 will be determined before and after intervention.

  6. change from baseline insulin resistance levels at 12 weeks

    Time frame: 12 weeks

    Level of insulin resistance will be assessed using the homeostasis model assessment (HOMA-IR) index [fasting glucose (mg/dL) X fasting insulin (µU/mL) / 405].

  7. change from baseline Six-minute walk distance at 12 weeks

    Time frame: 12 weeks

    The distance (in meters) participants walked in 6 minutes will be determined. Longer distance indicates better cardiorespiratory fitness.

  8. change from baseline 30 seconds Chair Stand Test at 12 weeks

    Time frame: 12 weeks

    The number of repetitions participants could perform sit-to-stand will be recorded. Higher number of repetitions indicates greater lower-body strength.

Sponsors and collaborators

Lead sponsor

Chiang Mai University

Other

Registry information

Official study 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

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Feb 24, 2021
Registry last updated
Feb 14, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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