Tokyo, Oct. 8 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000063209) titled 'Effects of cocoa supplementation and aerobic exercise on arterial stiffness in sedentary middle-to-late aged adults' on Oct. 7.
Study Type:
Interventional
Study Design:
Basic Design - Parallel
Randomization - Randomized
Blinding - Single blind -investigator(s) and assessor(s) are blinded
Control - No treatment
Primary Sponsor:
Institute - Universiti Malaya
Condition:
Condition - Arterial stiffness
Classification by malignancy - Others
Genomic information - NO
Objective:
Narrative objectives1 - To investigate the effects of 8 weeks of cocoa supplementation and aerobic exercise on arterial stiffness in sedentary middle-to-late adults.
Basic objectives2 - Efficacy
Intervention:
Interventions/Control_1 - Participants in the COEX group consumed 100% cocoa powder daily at a dose of 0.17 g/kg/day for 8 weeks and participated in a supervised square dancing program three times per week for 8 weeks. Each session lasted 60 minutes and consisted of a 10-minute warm-up, 40 minutes of square dancing, and a 10-minute stretching period.
Exercise intensity was maintained at 50% to 70% of age-predicted maximum heart rate (HRmax). HRmax was estimated using the formula 220 minus age. Participants received real-time heart rate feedback and adjusted exercise intensity to remain within the target heart rate range. When heart rate was below the target range, participants increased movement amplitude and stepping cadence. When heart rate exceeded the target range, participants reduced movement amplitude and exercise pace until heart rate returned to the prescribed range. All exercise sessions were supervised by an instructor.
Interventions/Control_2 - Participants in the COCO group consumed 100% cocoa powder at a dose of 0.17 g/kg/day for 8 weeks. The cocoa powder was mixed with 120 mL of water and consumed 30 minutes after dinner, without added milk or sugar. Before the intervention, participants completed a 1-week food diary to identify the use of other polyphenol-rich food supplements. Participants were instructed to maintain their dietary habits as closely as possible to those recorded in the food diary throughout the intervention period.
Eligibility:
Age-lower limit - 55
years-old
=
Gender - Male and Female
Key inclusion criteria - Aged 55-65 years middle-to-late adults; BMI < 30 kg/m2 (non-obese); middle-to-late adults who exercise less (exercising
fewer than 150 minutes per week of moderate activity);
Key exclusion criteria - Have cardiovascular disease and any kidney, lung, or metabolic disorders.
Target Size - 45
Recruitment Status:
Recruitment status - Completed
Date of protocol fixation - 2025 Year 04 Month 25 Day
Date of IRB - 2025 Year 04 Month 25 Day
Anticipated trial start date - 2025 Year 06 Month 15 Day
Last follow-up date - 2025 Year 09 Month 30 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000072346
Disclaimer: Curated by HT Syndication.