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Completed

NCT Number: NCT03781999

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

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).

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Key information

Conditions

Fitness

Age range

60 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

BioActor

Maastricht, 6229GS, Netherlands

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Actiful

Dietary Supplement

supplement containing 500 mg orange extract and 200 mg pomegranate actives

Placebo

Other

Maltodextrin

Primary outcomes

  1. 6 Minute Walking Test

    Time frame: 0-4-8-12 weeks

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

Secondary outcomes

  1. Senior Fitness test

    Time frame: 0-4-8-12 weeks

    Fitness tests to see if Actiful improves physical activity level

  2. Daily physical activity measured by accelerometers

    Time frame: 0-4-8-12 weeks

    Accelerometer is worn for 7 days prior to each testing day

  3. Quality of life questionnaire - WHOQOL-100

    Time frame: 0-4-8-12 weeks

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

  4. Concentration of blood marker TAC

    Time frame: 0-4-8-12 weeks

    Total antioxidant capacity measurement in plasma

Sponsors and collaborators

Lead sponsor

Bioactor

Other

Registry information

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Dec 20, 2018
Registry last updated
Jun 24, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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