The Effect of Sweet Orange and Pomegranate Extract Supplementation on Exercise Capacity in Middle-aged Adults

NCT05133778 | Completed DMC

• 1 other identifier: Actiful2
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of the present study is to investigate the effect of 12-week long daily administration of a sweet orange and pomegranate extract on exercise capacity in healthy adults.

Conditions

Exercise Capacity

Keywords

Sweet orange; Pomegranate; Polyphenols; Exercise capacity; Ekblom-bak

Outcome Measures

Primary Outcomes (1)

• Change in endurance capacity

  An Ekblom-bak cycling test is used to estimate the maximal oxygen consumption

  12 weeks

Secondary Outcomes (21)

• Change in Daily physical activity

  12 weeks

• Change in Handgrip strength

  12 weeks

• Change in Self reported quality of life

  12 weeks

• Change in General health

  12 weeks

• Change in Vitality

  12 weeks

Study Arms (2)

Sweet orange and pomegranate extract

EXPERIMENTAL

Supplementation

Dietary Supplement: Sweet orange and pomegranate extract

Maltodextrin

PLACEBO COMPARATOR

Supplementation

Other: Maltodextrin control

Interventions

Sweet orange and pomegranate extract DIETARY_SUPPLEMENT

From the daily 650mg total supplementation of the investigational product, 250 mg will be of pomegranate extract containing 100mg of punicalagin. The remaining 400 mg will consist of sweet orange peel extract containing 360 mg of hesperidin.

Sweet orange and pomegranate extract

Maltodextrin control OTHER

Supplementation with 760 mg maltodextrin

Maltodextrin

Eligibility Criteria

• Age: 40 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Healthy male/female (based on medical history provided during a general health questionnaire)
• Age between 40 - 65 yrs
• Overweight (BMI ≥25 to ≤29.9 kg/m2)
• Sedentary subjects (Low Level \[\<600 MET-minutes/week\] as assessed by the Physical Activity Questionnaire (IPAQ))

You may not qualify if:

• Allergy to test product/control or citrus fruits and pomegranate
• Medical conditions that might interfere with endpoints or compromise participant safety during testing (e.g. Cardiovascular diseases, cancer, Parkinson's disease, Gastrointestinal diseases or abdominal surgery) to be decided by the principal investigator
• Use of medication that might interfere with endpoints (i.e.: β-blockers, antioxidant, antidepressants)
• High fasting blood glucose (FBG ≥100 mg/dL)
• Recent skeletal muscle injury in less than one month before the start of the study
• Use of antibiotics within 3 months prior to Visit 2
• Use of probiotics or supplements containing vitamins, minerals or antioxidants four weeks prior to Visit 2
• Regular smoking (including use of e-cigarettes)
• Inability to correctly perform the PA test during screening/familiarization
• Abuse of alcohol (alcohol consumption \>20 units/week) and/or drugs
• Plans to change diet or medication for the duration of the study
• Treatment with an investigational drug (phase 1-3) 180 days before the start of the study
• Inability to understand study information and/or communicate with staff

Sponsors & Collaborators

• Maastricht University: lead
• BioActor B.V.: collaborator

Study Sites (1)

Maastricht University

Maastricht, Netherlands

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomized, double-blind, placebo-controlled parallel trial

Study Record Dates

• First Submitted: October 26, 2021
• First Posted: November 24, 2021
• Study Start: November 1, 2021
• Primary Completion: April 1, 2025
• Study Completion: April 1, 2025
• Last Updated: June 13, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)