The growing ageing population has resulted in an increase in the prevalence of frailty, cognitive disorders and cardiovascular diseases, representing a major cause of disability in older adults. Inflammation has been suggested as a pivotal factor leading to these disorders and is exacerbated by obesity. Polyphenols are antioxidants and anti-inflammatory agents that have been previously linked to a decrease in inflammation and cardiometabolic risk factors and an improvement in physical and cognitive function, yet research remain limited and inconclusive. This study aims to assess the effect of daily pomegranate extract supplementation on inflammatory response, cognitive and physical function and cardiometabolic risk factors in older adults. Seventy-one normal weight and overweight participants (55-70 years) will be assigned to consume either pomegranate extract capsules or placebo capsules for 12 weeks. Anthropometric measures (weight, height, waist circumference and hip circumference), body composition, blood pressure and a fasted venous blood sample will be collected during each visit at baseline, week 6 \& week 12. Participants will also undergo computerised cognitive tests and physical function tests. Inflammatory markers, telomerase activity, serum glucose and lipid levels will be analysed. Diet diaries will be collected 3 times (at baseline, week 6 \& week 12) during the intervention. This study will help elucidate the effects of pomegranate supplementation and inform future longitudinal trials looking at the combination of antioxidants and other lifestyle factors (such as physical activity) on the promotion of well-being and healthy ageing.
After signing an informed consent, participants will be asked to attend the Physiology Lab at Manchester Metropolitan University at baseline, week 6 and week 12. Anthropometric measures (weight, height, waist circumference and hip circumference) will be collected during each visit, and body composition will be measured using air displacement plethysmography (BOD POD®). Blood pressure will be measured 3 times after a 10-minute rest based on the World Health Organisation (WHO) protocol and a fasted venous blood sample (20 ml) will be collected. Participants will then undergo physical assessment tests (to assess standing balance, gait speed, and chair sit to stand) and computerised cognitive tests (to assess executive function, memory, vigilance and attention). Participants will also answer a general demographic and lifestyle questionnaire during the first visit. To control for changes in the diet, they will be asked to fill a paper-based 3-day food diary 3 times (at baseline, week 6 \& week 12) during the intervention. Food diaries will be analysed using Nutritics (v.4) dietary analysis software.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Enrollment
86
Two capsules of pomegranate extract (740 mg) will be taken daily at any time of the day for a period of 12 weeks.
One capsule of containing no pomegranate extract will be taken daily at any time of the day for a period of 12 weeks.
Manchester Metropolitan University school of Health sciences
Manchester, United Kingdom
Interleukin-6 (IL-6) levels
Changes in IL-6 levels will be measured in a fasted blood sample using a commercially available assay kit.
Time frame: Baseline, week 6 & week 12
CRP (C-reactive protein) levels
Changes in CRP levels will be measured in a fasted blood sample using a commercially available assay kit.
Time frame: Baseline, week 6 & week 12
Interleukin 1 (IL-1) levels
Changes in IL-1 levels will be measured in a fasted blood sample using a commercially available assay kit.
Time frame: Baseline, week 6 & week 12
Interleukin 2 (IL-2) levels
Changes in IL-2 levels will be measured in a fasted blood sample using a commercially available assay kit.
Time frame: Baseline, week 6 & week 12
Insulin growth factor-1 (IGF-1) levels
Changes in IGF-1 levels will be measured in a fasted blood sample using a commercially available assay kit.
Time frame: Baseline, week 6 & week 12
Tumour necrosis factor (TNF-α) levels
Changes in TNF-α levels will be measured in a fasted blood sample using a commercially available assay kit.
Time frame: Baseline, week 6 & week 12
Plasminogen Activator Inhibitor-1 (PAI-1) levels
Changes in PAI-1 levels will be measured in a fasted blood sample using a commercially available assay kit.
Time frame: Baseline, week 6 & week 12
Telomerase activity
Changes in telomerase activity will be measured in a fasted blood sample using a commercially available assay kit.
Time frame: Baseline, week 6 & week 12
Corsi block-tapping test
Changes in working memory will be assessed using Corsi block-tapping computerised cognitive test.
Time frame: Baseline, week 6 & week 12
Rey Verbal Learning test
Changes in working memory will be assessed using Rey Verbal Learning computerised cognitive test.
Time frame: Baseline, week 6 & week 12
Tower of Hanoi test
Changes in executive function will be assessed using Tower of Hanoi computerised cognitive test.
Time frame: Baseline, week 6 & week 12
Wisconsin test
Changes in executive function will be assessed using Wisconsin computerised cognitive test.
Time frame: Baseline, week 6 & week 12
Stroop test
Changes in executive function will be assessed using Stroop computerised cognitive test.
Time frame: Baseline, week 6 & week 12
Digits span test
Changes in working memory will be assessed using Digits span computerised cognitive test.
Time frame: Baseline, week 6 & week 12
Hand grip strength
Changes in muscle strength will be assessed using hand grip strength physical test.
Time frame: Baseline, week 6 & week 12
Standing balance
Changes in muscle function will be assessed using standing balance physical test.
Time frame: Baseline, week 6 & week 12
Gait speed
Changes in muscle function will be assessed using gait speed physical test.
Time frame: Baseline, week 6 & week 12
Chair sit to stand
Changes in muscle function will be assessed using chair sit to stand physical test.
Time frame: Baseline, week 6 & week 12
Fasting serum glucose levels
Changes in glucose levels will be measured in a fasted blood sample using a commercially available assay kit.
Time frame: Baseline, week 6 & week 12
Fasting lipid levels
Changes in lipid levels (TC, HDL, LDL \& TG) will be measured in a fasted blood sample using a commercially available assay kit.
Time frame: Baseline, week 6 & week 12
Blood pressure
Changes in blood pressure will be Blood pressure will be measured 3 times after a 10-minute rest based on the WHO protocol.
Time frame: Baseline, week 6 & week 12
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