Pomegranate Extract and Inflammageing

NCT05588479 | Completed

• 1 other identifier: 47627
• Study Type: interventional
• Target: 86
• Locations: 1 country
• Sites: 1

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.

Conditions

Aging

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (20)

• CRP (C-reactive protein) levels

  Baseline, week 6 & week 12

• Interleukin 1 (IL-1) levels

  Baseline, week 6 & week 12

• Interleukin 2 (IL-2) levels

  Baseline, week 6 & week 12

• Insulin growth factor-1 (IGF-1) levels

  Baseline, week 6 & week 12

• Tumour necrosis factor (TNF-α) levels

  Baseline, week 6 & week 12

Study Arms (2)

Control

PLACEBO COMPARATOR

Capsules with no pomegranate extract One capsule to be administered once a day for 12 weeks.

Dietary Supplement: Control

Intervention

EXPERIMENTAL

Capsules with 740 mg of pomegranate extract Two capsules to be administered once a day for 12 weeks.

Dietary Supplement: Pomegranate extract

Interventions

Pomegranate extract DIETARY_SUPPLEMENT

Two capsules of pomegranate extract (740 mg) will be taken daily at any time of the day for a period of 12 weeks.

Intervention

Control DIETARY_SUPPLEMENT

One capsule of containing no pomegranate extract will be taken daily at any time of the day for a period of 12 weeks.

Control

Eligibility Criteria

• Age: 55 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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..).

Sponsors & Collaborators

• Manchester Metropolitan University: lead

Study Sites (1)

Manchester Metropolitan University school of Health sciences

Manchester, M15 6BG, United Kingdom

Location

MeSH Terms

Interventions

pomegranate fruit rind

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Capsules were masked by the manufacturer and blinded to outcome assessors.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior lecturer in Nutrition and Dietetics

Model Details: Two-arm double blind parallel trial where participants will be randomly assigned to receive either placebo capsules (control) or pomegranate extract capsules (740 mg) for 12 weeks.

Study Record Dates

• First Submitted: October 12, 2022
• First Posted: October 20, 2022
• Study Start: December 10, 2022
• Primary Completion: June 30, 2024
• Study Completion: June 30, 2024
• Last Updated: January 20, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)