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

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ClinicalTrials.gov Identifier: NCT03781999
Recruitment Status : Completed
First Posted : December 20, 2018
Last Update Posted : June 24, 2019
Sponsor:
Information provided by (Responsible Party):
BioActor

Brief 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).


Condition or disease Intervention/treatment Phase
Fitness Dietary Supplement: Actiful Other: Placebo Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 37 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Supportive Care
Official Title: The Effect of a Combination of Orange- and Pomegranate Actives on Physical Fitness in Elderly People
Actual Study Start Date : June 25, 2018
Actual Primary Completion Date : January 17, 2019
Actual Study Completion Date : January 17, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Actiful
a supplement containing 500 mg orange extract and 200 mg pomegranate actives
Dietary Supplement: Actiful
supplement containing 500 mg orange extract and 200 mg pomegranate actives

Placebo Comparator: Placebo
Maltodextrin
Other: Placebo
Maltodextrin




Primary Outcome Measures :
  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 Outcome Measures :
  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



Information from the National Library of Medicine

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Ages Eligible for Study:   60 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03781999


Locations
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Netherlands
BioActor
Maastricht, Netherlands, 6229GS
Sponsors and Collaborators
BioActor
Investigators
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Principal Investigator: Freddy Troost, Dr Maastricht University

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Responsible Party: BioActor
ClinicalTrials.gov Identifier: NCT03781999     History of Changes
Other Study ID Numbers: Actiful_001
First Posted: December 20, 2018    Key Record Dates
Last Update Posted: June 24, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by BioActor:
Performance
Polyphenols
Nutrition
Sports