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The effect of sweet orange and pomegranate extract supplementation on exercise capacity: a randomized controlled parallel intervention study in healthy overweight individuals

The effect of sweet orange and pomegranate extract supplementation on exercise capacity: a randomized controlled parallel intervention study in healthy overweight individuals - ActiFul 2

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON52281
Enrollment
52
Registered
2021-08-25
Start date
2021-12-01
Completion date
Unknown
Last updated
2026-03-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

physical fitness performance physical fitness

Interventions

12-week supplementation with 650 mg sweet orange and pomgranate extract (2 capsules per day) compared to placebo (760 mg maltodextrin).

Sponsors

Faculty of health, medicine and life sciences
Lead Sponsor

Eligibility

Age
18 Years to 64 Years

Inclusion criteria

Inclusion criteria: - Healthy male/female (based on medical history provided during a general health questionnaire) - Age between 40 - 65 yrs - Overweight (BMI >=25 to

Exclusion criteria

Exclusion criteria: - 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 >=126 mg/dL) - Recent skeletal muscle injury in less than one month before the start of the study - Use of antibiotics within 3 months prior 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

Design outcomes

Primary

MeasureTime frame
Change in aerobic capacity (VO2max), assessed with an Eklom-Bak submaximal cycling test.

Secondary

MeasureTime frame
- Daily physical activity as determined by accelerometer - Dietary intake as measured by a 3-day food record - Muscle strength as measured by Handgrip strength - Muscle cell proliferation and differentiation and mitochondrial biogenesis assessed in skeletal muscle biopsies - Quality of Life as measured by the WHO-QOL-100 questionnaire - General health as measured by SF-36 questionnaire - Vitality as measured by the Dutch Vitality Questionnaire (Vita-16) - Cardiometabolic health biomarkers, cortisol, C-reactive protein determined with ELISA - Antioxidative capacity measured with a Trolox equivalent antioxidant capacity (TEAC) assay

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP) · Data processed: Mar 14, 2026