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

• ClinicalTrials.gov Identifier: NCT04768725
• Recruitment Status: Recruiting
• First Posted: February 24, 2021
• Last Update Posted: February 25, 2022
• Sponsor: Chiang Mai University
• Information provided by (Responsible Party): Somporn Sungkarat, Chiang Mai University

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Obesity	Behavioral: Dietary intervention combined with physical-cognitive exergaming; Behavioral: Dietary intervention; Behavioral: Physical-cognitive intervention	Not Applicable

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 (Clinical Trial)
• Estimated Enrollment: 92 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Other
• 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
• Actual Study Start Date: September 26, 2021
• Estimated Primary Completion Date: December 2022
• Estimated Study Completion Date: May 2023

Arms and Interventions

Arm	Intervention/treatment
Active Comparator: 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).	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)].
Active Comparator: Physical-cognitive intervention; Participants will perform home-based physical-cognitive training for 60 minutes per session, 3 session a week.	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)].
Experimental: 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.	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)].
No Intervention: Control; Participants in the control group will be encouraged to continue their activities and calorie intakes as they usually would.

Outcome Measures

Primary Outcome Measures :

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 Outcome Measures :

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.

Eligibility Criteria

• Ages Eligible for Study: 45 Years to 59 Years (Adult)
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Contacts

Contact: Somporn Sungkarat, PhD; 6653949249; somporn.sungkarat@cmu.ac.th

Locations

Thailand

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

Chiang Mai, Thailand, 50200

Contact: Somporn Sungkarat, PhD +6653-94-9249 somporn.sungkarat@cmu.ac.th

Principal Investigator: Somporn Sungkarat, PhD

Sponsors and Collaborators

Chiang Mai University

Investigators

• Principal Investigator: Somporn Sungkarat, PhD; Chiang Mai University

More Information

• Responsible Party: Somporn Sungkarat, Associate Professor, Chiang Mai University
• ClinicalTrials.gov Identifier: NCT04768725
• Other Study ID Numbers: AMS-PT CMU 2564
• First Posted: February 24, 2021
• Last Update Posted: February 25, 2022
• Last Verified: February 2022

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Somporn Sungkarat, Chiang Mai University:

Dietary intervention; Cognitive function; Brain-derived neurotrophic factor; Exergaming; Obesity

Additional relevant MeSH terms:

Obesity; Overnutrition; Nutrition Disorders; Overweight; Body Weight