Pomegranate Extract and Inflammageing

Aging Clinical Trial

Official title:

Effects of Pomegranate Extract on Inflammatory Markers, Physical and Cognitive Function and Cardiometabolic Risk Factors in Older Adults: A Randomized Parallel Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05588479
• Other study ID #: 47627
• Status: Recruiting
• Phase: N/A
• Start date: January 9, 2023
• Est. completion date: August 31, 2024

Study information

• Verified date: March 2023
• Source: Manchester Metropolitan University
• Contact: Grace Farhat, PhD
• Phone: 01612472000
• Email: g.farhat[@]mmu.ac.uk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 (60-70 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.

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 isokinetic knee extension, isokinetic knee flexion, 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 information / eligibility

• Status: Recruiting
• Enrollment: 71
• Est. completion date: August 31, 2024
• Est. primary completion date: April 30, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 60 Years to 70 Years

Eligibility

Inclusion Criteria:

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. Exclusion Criteria: 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..).

Related Conditions & MeSH terms

• Aging

Intervention

Dietary Supplement:
• Pomegranate extract
One capsule of pomegranate extract (500 mg) will be taken daily at any time of the day for a period of 12 weeks.
• Control
One capsule of containing no pomegranate extract will be taken daily at any time of the day for a period of 12 weeks.

Locations

Country	Name	City	State
United Kingdom	Manchester Metropolitan University school of Health sciences	Manchester

Sponsors (1)

Lead Sponsor	Collaborator
Manchester Metropolitan University

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Interleukin-6 (IL-6) levels	Changes in IL-6 levels will be measured in a fasted blood sample using a commercially available assay kit.	Baseline, week 6 & week 12
Secondary	CRP (C-reactive protein) levels	Changes in CRP levels will be measured in a fasted blood sample using a commercially available assay kit.	Baseline, week 6 & week 12
Secondary	Interleukin 1 (IL-1) levels	Changes in IL-1 levels will be measured in a fasted blood sample using a commercially available assay kit.	Baseline, week 6 & week 12
Secondary	Interleukin 2 (IL-2) levels	Changes in IL-2 levels will be measured in a fasted blood sample using a commercially available assay kit.	Baseline, week 6 & week 12
Secondary	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.	Baseline, week 6 & week 12
Secondary	Tumour necrosis factor (TNF-a) levels	Changes in TNF-a levels will be measured in a fasted blood sample using a commercially available assay kit.	Baseline, week 6 & week 12
Secondary	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.	Baseline, week 6 & week 12
Secondary	Telomerase activity	Changes in telomerase activity will be measured in a fasted blood sample using a commercially available assay kit.	Baseline, week 6 & week 12
Secondary	Corsi block-tapping test	Changes in working memory will be assessed using Corsi block-tapping computerised cognitive test.	Baseline, week 6 & week 12
Secondary	Rey Verbal Learning test	Changes in working memory will be assessed using Rey Verbal Learning computerised cognitive test.	Baseline, week 6 & week 12
Secondary	Tower of Hanoi test	Changes in executive function will be assessed using Tower of Hanoi computerised cognitive test.	Baseline, week 6 & week 12
Secondary	Wisconsin test	Changes in executive function will be assessed using Wisconsin computerised cognitive test.	Baseline, week 6 & week 12
Secondary	Stroop test	Changes in executive function will be assessed using Stroop computerised cognitive test.	Baseline, week 6 & week 12
Secondary	Digits span test	Changes in working memory will be assessed using Digits span computerised cognitive test.	Baseline, week 6 & week 12
Secondary	Hand grip strength	Changes in muscle strength will be assessed using hand grip strength physical test.	Baseline, week 6 & week 12
Secondary	isokinetic knee extension	Changes in muscle strength will be assessed using isokinetic knee extension physical test.	Baseline, week 6 & week 12
Secondary	Isokinetic knee flexion	Changes in muscle strength will be assessed using isokinetic knee flexion physical test.	Baseline, week 6 & week 12
Secondary	Standing balance	Changes in muscle function will be assessed using standing balance physical test.	Baseline, week 6 & week 12
Secondary	Gait speed	Changes in muscle function will be assessed using gait speed physical test.	Baseline, week 6 & week 12
Secondary	Chair sit to stand	Changes in muscle function will be assessed using chair sit to stand physical test.	Baseline, week 6 & week 12
Secondary	Fasting serum glucose levels	Changes in glucose levels will be measured in a fasted blood sample using a commercially available assay kit.	Baseline, week 6 & week 12
Secondary	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.	Baseline, week 6 & week 12
Secondary	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.	Baseline, week 6 & week 12