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CompletedNCT03781999Updated Jun 24, 2019

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

An interventional study of Actiful and Placebo in Fitness, sponsored by BioActor. Completed at 1 site in Netherlands. Open to participants aged 60 Years to 75 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-06-24.

Sponsored by BioActor · Not applicable, Interventional, and Supportive care

From the registry’s dates

  • Registered 5 months after the study started (first participant enrolled Jun 2018, registered Dec 2018).
Phase
Not applicable
Study type
Interventional
Enrollment
37
Allocation
Randomized
Ages
60 Years to 75 Years
Sex
All
01

Study summary

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).

Read the detailed 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.

02

Conditions studied

  • Fitness

Keywords

  • Performance
  • Polyphenols
  • Nutrition
  • Sports
03

In context

Lead sponsor

BioActor is the lead sponsor of 5 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
60 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

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

Exclusion criteria

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
05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Double (Participant, Investigator)
Enrollment
37 participants (actual)

Study arms

  • Experimental
    Actiful

    a supplement containing 500 mg orange extract and 200 mg pomegranate actives

    Dietary Supplement: Actiful

  • Placebo comparator
    Placebo

    Maltodextrin

    Other: Placebo

Interventions

  • Dietary supplementActiful

    supplement containing 500 mg orange extract and 200 mg pomegranate actives

  • OtherPlacebo

    Maltodextrin

06

What researchers measure

Primary outcomes

  1. 6 Minute Walking Test

    Participants have to walk for 6 minutes, as fast as possible. Total distance will be measured.

    Time frame: 0-4-8-12 weeks

Secondary outcomes

  1. Senior Fitness test

    Fitness tests to see if Actiful improves physical activity level

    Time frame: 0-4-8-12 weeks

  2. Daily physical activity measured by accelerometers

    Accelerometer is worn for 7 days prior to each testing day

    Time frame: 0-4-8-12 weeks

  3. Quality of life questionnaire - WHOQOL-100

    Participants will be asked to fill out the WHOQOL-100 questionnaire to determine quality of life. Scale from 1-5 (disagree-agree)

    Time frame: 0-4-8-12 weeks

  4. Concentration of blood marker TAC

    Total antioxidant capacity measurement in plasma

    Time frame: 0-4-8-12 weeks

07

Study locations

1 site
  • BioActor
    Maastricht, 6229GS, Netherlands
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 24, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03781999
Lead sponsor
BioActor
Responsible party
Sponsor
First posted
Dec 20, 2018
Start date
Jun 25, 2018
Primary completion
Jan 17, 2019
Completion
Jan 17, 2019
Last update
Jun 24, 2019

Study contacts

Freddy Troost, Dr
principal investigator · Maastricht University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jun 2019. You cannot join it, but the record below documents what was studied.

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