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

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

Study Description

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.

Study Design

• 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

Arms and Interventions

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

Outcome Measures

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

Eligibility Criteria

• 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

Contacts and Locations

Locations

Netherlands

BioActor

Maastricht, Netherlands, 6229GS

Sponsors and Collaborators

BioActor

Investigators

• Principal Investigator: Freddy Troost, Dr; Maastricht University

More Information

• Responsible Party: BioActor
• ClinicalTrials.gov Identifier: NCT03781999
• Other Study ID Numbers: Actiful_001
• First Posted: December 20, 2018
• Last Update Posted: June 24, 2019
• Last Verified: June 2019

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• 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