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).

Study Overview

• Status: Completed
• Conditions: Fitness
• Intervention / Treatment: Other: Placebo; Dietary supplement: Actiful

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 Type: Interventional
• Enrollment (Actual): 37
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Netherlands
  • Maastricht, Netherlands, 6229GS
    • BioActor

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 60 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo; Maltodextrin	Other: Placebo; Maltodextrin
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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Senior Fitness test	Fitness tests to see if Actiful improves physical activity level	0-4-8-12 weeks
Daily physical activity measured by accelerometers	Accelerometer is worn for 7 days prior to each testing day	0-4-8-12 weeks
Quality of life questionnaire - WHOQOL-100	Participants will be asked to fill out the WHOQOL-100 questionnaire to determine quality of life. Scale from 1-5 (disagree-agree)	0-4-8-12 weeks
Concentration of blood marker TAC	Total antioxidant capacity measurement in plasma	0-4-8-12 weeks

Collaborators and Investigators

• Sponsor: BioActor
• Investigators: Principal Investigator: Freddy Troost, Dr, Maastricht University

Study record dates

Study Major Dates

• Study Start (Actual): June 25, 2018
• Primary Completion (Actual): January 17, 2019
• Study Completion (Actual): January 17, 2019

Study Registration Dates

• First Submitted: December 10, 2018
• First Submitted That Met QC Criteria: December 18, 2018
• First Posted (Actual): December 20, 2018

Study Record Updates

• Last Update Posted (Actual): June 24, 2019
• Last Update Submitted That Met QC Criteria: June 20, 2019
• Last Verified: June 1, 2019

More Information

Terms related to this study

• Keywords: Nutrition; Performance; Polyphenols; Sports
• Other Study ID Numbers: Actiful_001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No