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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

37 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-06-25

Study Completion Date

2019-01-17

Brief Summary

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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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Detailed Description

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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.

Conditions

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Fitness

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Actiful

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

Group Type EXPERIMENTAL

Actiful

Intervention Type DIETARY_SUPPLEMENT

supplement containing 500 mg orange extract and 200 mg pomegranate actives

Placebo

Maltodextrin

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

Maltodextrin

Interventions

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Actiful

supplement containing 500 mg orange extract and 200 mg pomegranate actives

Intervention Type DIETARY_SUPPLEMENT

Placebo

Maltodextrin

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

60 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes