Pomegranate Extract and Inflammageing

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

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.

Study Overview

• Status: Completed
• Conditions: Aging
• Intervention / Treatment: Dietary supplement: Control; Dietary supplement: Pomegranate extract

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.

• Study Type: Interventional
• Enrollment (Actual): 86
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • Manchester, United Kingdom, M15 6BG
    • Manchester Metropolitan University school of Health sciences

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 60 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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..).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Control; Capsules with no pomegranate extract One capsule to be administered once a day for 12 weeks.	Dietary supplement: Control; One capsule of containing no pomegranate extract will be taken daily at any time of the day for a period of 12 weeks.
Experimental: Intervention; Capsules with 740 mg of pomegranate extract Two capsules to be administered once a day for 12 weeks.	Dietary supplement: Pomegranate extract; Two capsules of pomegranate extract (740 mg) will be taken daily at any time of the day for a period of 12 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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.	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.	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.	Baseline, week 6 & week 12
Corsi block-tapping test	Changes in working memory will be assessed using Corsi block-tapping computerised cognitive test.	Baseline, week 6 & week 12
Rey Verbal Learning test	Changes in working memory will be assessed using Rey Verbal Learning computerised cognitive test.	Baseline, week 6 & week 12
Tower of Hanoi test	Changes in executive function will be assessed using Tower of Hanoi computerised cognitive test.	Baseline, week 6 & week 12
Wisconsin test	Changes in executive function will be assessed using Wisconsin computerised cognitive test.	Baseline, week 6 & week 12
Stroop test	Changes in executive function will be assessed using Stroop computerised cognitive test.	Baseline, week 6 & week 12
Digits span test	Changes in working memory will be assessed using Digits span computerised cognitive test.	Baseline, week 6 & week 12
Hand grip strength	Changes in muscle strength will be assessed using hand grip strength physical test.	Baseline, week 6 & week 12
Standing balance	Changes in muscle function will be assessed using standing balance physical test.	Baseline, week 6 & week 12
Gait speed	Changes in muscle function will be assessed using gait speed physical test.	Baseline, week 6 & week 12
Chair sit to stand	Changes in muscle function will be assessed using chair sit to stand physical test.	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.	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.	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.	Baseline, week 6 & week 12

Collaborators and Investigators

• Sponsor: Manchester Metropolitan University
• Collaborators: Euromed, S.A.

Study record dates

Study Major Dates

• Study Start (Actual): December 10, 2022
• Primary Completion (Actual): June 30, 2024
• Study Completion (Actual): June 30, 2024

Study Registration Dates

• First Submitted: October 12, 2022
• First Submitted That Met QC Criteria: October 18, 2022
• First Posted (Actual): October 20, 2022

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 17, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Other Study ID Numbers: 47627

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No