Clinical trial NCT03781999: The Effect of a Combination of Orange- and Pomegranate Actives on Physical Fitness in Elderly People
Official title: The Effect of a Combination of Orange- and Pomegranate Actives on Physical Fitness in Elderly People
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Fitness
Keywords: Performance
Polyphenols
Nutrition
Sports
Lead sponsor: BioActor
Sponsor class: INDUSTRY
First posted: 2018-12-20
Enrollment: 37
Sex: ALL
Minimum age (years): 60
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: SUPPORTIVE_CARE

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).

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.

Eligibility 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

Primary outcomes:
measure: 6 Minute Walking Test
timeFrame: 0-4-8-12 weeks
Secondary outcomes:
measure: Senior Fitness test
timeFrame: 0-4-8-12 weeks
measure: Daily physical activity measured by accelerometers
timeFrame: 0-4-8-12 weeks
measure: Quality of life questionnaire - WHOQOL-100
timeFrame: 0-4-8-12 weeks
measure: Concentration of blood marker TAC
timeFrame: 0-4-8-12 weeks
Other outcomes:
Locations:
city: Maastricht
country: Netherlands
facility: BioActor
Study officials:
affiliation: Maastricht University
name: Freddy Troost, Dr
role: PRINCIPAL_INVESTIGATOR
References: