Pomegranate Extract and Inflammageing
- Conditions
- Aging
- Interventions
- Dietary Supplement: ControlDietary Supplement: Pomegranate extract
- Registration Number
- NCT05588479
- Lead Sponsor
- Manchester Metropolitan University
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 86
Age 55-70 years; Normal weight (BMI 18.5-24.9 Kg/m2) and overweight (BMI 25- 29.9 Kg/m2); All genders; No diagnosed metabolic diseases.
Participants who have been on a weight loss regimen over the past 2 months, those with diagnosed chronic disease (diabetes, cardiovascular disease (CVD), renal disease etc...) or taking any medications that could modulate inflammation (statins etc..).
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Control Control Capsules with no pomegranate extract One capsule to be administered once a day for 12 weeks. Intervention Pomegranate extract Capsules with 500 mg of pomegranate extract One capsule to be administered once a day for 12 weeks.
- Primary Outcome Measures
Name Time Method Interleukin-6 (IL-6) levels Baseline, week 6 & week 12 Changes in IL-6 levels will be measured in a fasted blood sample using a commercially available assay kit.
- Secondary Outcome Measures
Name Time Method Chair sit to stand Baseline, week 6 & week 12 Changes in muscle function will be assessed using chair sit to stand physical test.
Interleukin 1 (IL-1) levels Baseline, week 6 & week 12 Changes in IL-1 levels will be measured in a fasted blood sample using a commercially available assay kit.
Insulin growth factor-1 (IGF-1) levels Baseline, week 6 & week 12 Changes in IGF-1 levels will be measured in a fasted blood sample using a commercially available assay kit.
Wisconsin test Baseline, week 6 & week 12 Changes in executive function will be assessed using Wisconsin computerised cognitive test.
Hand grip strength Baseline, week 6 & week 12 Changes in muscle strength will be assessed using hand grip strength physical test.
Standing balance Baseline, week 6 & week 12 Changes in muscle function will be assessed using standing balance physical test.
Gait speed Baseline, week 6 & week 12 Changes in muscle function will be assessed using gait speed physical test.
Fasting serum glucose levels Baseline, week 6 & week 12 Changes in glucose levels will be measured in a fasted blood sample using a commercially available assay kit.
CRP (C-reactive protein) levels Baseline, week 6 & week 12 Changes in CRP levels will be measured in a fasted blood sample using a commercially available assay kit.
Interleukin 2 (IL-2) levels Baseline, week 6 & week 12 Changes in IL-2 levels will be measured in a fasted blood sample using a commercially available assay kit.
Telomerase activity Baseline, week 6 & week 12 Changes in telomerase activity will be measured in a fasted blood sample using a commercially available assay kit.
Corsi block-tapping test Baseline, week 6 & week 12 Changes in working memory will be assessed using Corsi block-tapping computerised cognitive test.
Tower of Hanoi test Baseline, week 6 & week 12 Changes in executive function will be assessed using Tower of Hanoi computerised cognitive test.
Stroop test Baseline, week 6 & week 12 Changes in executive function will be assessed using Stroop computerised cognitive test.
Digits span test Baseline, week 6 & week 12 Changes in working memory will be assessed using Digits span computerised cognitive test.
Tumour necrosis factor (TNF-α) levels Baseline, week 6 & week 12 Changes in TNF-α levels will be measured in a fasted blood sample using a commercially available assay kit.
Plasminogen Activator Inhibitor-1 (PAI-1) levels Baseline, week 6 & week 12 Changes in PAI-1 levels will be measured in a fasted blood sample using a commercially available assay kit.
Rey Verbal Learning test Baseline, week 6 & week 12 Changes in working memory will be assessed using Rey Verbal Learning computerised cognitive test.
Fasting lipid levels Baseline, week 6 & week 12 Changes in lipid levels (TC, HDL, LDL \& TG) will be measured in a fasted blood sample using a commercially available assay kit.
Blood pressure Baseline, week 6 & week 12 Changes in blood pressure will be Blood pressure will be measured 3 times after a 10-minute rest based on the WHO protocol.
Trial Locations
- Locations (1)
Manchester Metropolitan University school of Health sciences
🇬🇧Manchester, United Kingdom