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

Not Applicable

Completed

• Conditions: Fitness
• Interventions: Other: Placebo; Dietary Supplement: Actiful

• Registration Number: NCT03781999
• Lead Sponsor: 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).

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.

Study Timeline

• Study Start: 2018-06-25
• Study First Submitted: 2018-12-10
• Study First Submitted QC: 2018-12-18
• Study First Posted: 2018-12-20
• Primary Completion: 2019-01-17
• Study Completion: 2019-01-17
• Status Verified: 2019-06
• Last Update Submitted: 2019-06-20
• Last Update Posted: 2019-06-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 37

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Maltodextrin
Actiful	Actiful	a supplement containing 500 mg orange extract and 200 mg pomegranate actives

Primary Outcome Measures

Name	Time	Method
6 Minute Walking Test	0-4-8-12 weeks	Participants have to walk for 6 minutes, as fast as possible. Total distance will be measured.

Secondary Outcome Measures

Name	Time	Method
Senior Fitness test	0-4-8-12 weeks	Fitness tests to see if Actiful improves physical activity level
Concentration of blood marker TAC	0-4-8-12 weeks	Total antioxidant capacity measurement in plasma
Daily physical activity measured by accelerometers	0-4-8-12 weeks	Accelerometer is worn for 7 days prior to each testing day
Quality of life questionnaire - WHOQOL-100	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)

Trial Locations

Locations (1)

BioActor; 🇳🇱 Maastricht, Netherlands