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The Effect of a Combination of Orange- and Pomegranate Actives on Physical Fitness in Elderly People

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BioActor

Status

Completed

Conditions

Fitness

Treatments

Dietary Supplement: Actiful
Other: Placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT03781999
Actiful_001

Details and patient eligibility

About

The primary objective of this study is to determine the effect of daily supplementation of a combined orange- and pomegranate extract for a period of 4 weeks on physical fitness compared to placebo.

In this crossover study, participants will daily receive either a placebo or Actiful®, a supplement containing 500 mg orange extract and 200 mg pomegranate actives, for 4 weeks followed by a wash-out period of 4 to 8 weeks. Subsequently, the second intervention period of 4 weeks (active product or placebo) will take place. The product and placebo will be supplied in capsules that participants can ingest with a glas of water (daily, prior to breakfast).

Full description

Dietary habits and physical activity are two important components of a healthy lifestyle. Targeted nutritional interventions may improve health and stimulate physical activity. Both orange extracts and pomegranate concentrate have been shown to exert beneficial effects on health and exercise performance. However, the effects of a combination of the two extracts on exercise and physical activity have not been investigated yet. It is expected that this combination may be an effective dietary way to improve exercise performance, physical activity in the free-living state, and quality of life in a middle aged population.

Enrollment

37 patients

Sex

All

Ages

60 to 75 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • 60 - 75 years old
  • non smoking
  • BMI 18 -28 kg/m²

Exclusion criteria

  • Allergy to test product/placebo or citrus fruits
  • BMI lower than 18 or higher than 28
  • Recent muscle injury in less than one month before the start of the study
  • Inability to perform the fitness tests
  • Medical conditions that might influence outcome measure or participant safety during testing, including but not limited to: severe cardiovascular disease, cancer, Parkinson's disease. To be decided by PI.
  • High blood pressure (systolic ≥ 140 mmHg, diastolic ≥ 90 mmHg)
  • Use of medication that may interfere with the study results, use of beta-blockers
  • Administration of investigational drugs or participation in any scientific intervention study which may interfere with this study (to be decided by the principle investigator), in the 180 days prior to the study
  • Abuse of products; alcohol (> 20 alcoholic units per week) and drugs

Trial design

Primary purpose

Supportive Care

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

Double Blind

37 participants in 2 patient groups, including a placebo group

Actiful
Experimental group
Description:
a supplement containing 500 mg orange extract and 200 mg pomegranate actives
Treatment:
Dietary Supplement: Actiful
Placebo
Placebo Comparator group
Description:
Maltodextrin
Treatment:
Other: Placebo

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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