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

NCT03781999 | Completed

• 1 other identifier: Actiful_001
• Study Type: interventional
• Target: 37
• Locations: 1 country
• Sites: 1

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).

Conditions

Fitness

Keywords

Performance; Polyphenols; Nutrition; Sports

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Senior Fitness test

  0-4-8-12 weeks

• Daily physical activity measured by accelerometers

  0-4-8-12 weeks

• Quality of life questionnaire - WHOQOL-100

  0-4-8-12 weeks

• Concentration of blood marker TAC

  0-4-8-12 weeks

Study Arms (2)

Actiful

EXPERIMENTAL

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

Dietary Supplement: Actiful

Placebo

PLACEBO COMPARATOR

Maltodextrin

Other: Placebo

Interventions

Actiful DIETARY_SUPPLEMENT

supplement containing 500 mg orange extract and 200 mg pomegranate actives

Actiful

Placebo OTHER

Maltodextrin

Placebo

Eligibility Criteria

• Age: 60 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years old
• non smoking
• BMI 18 -28 kg/m²

You may not qualify if:

• 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

Sponsors & Collaborators

• BioActor: lead

Study Sites (1)

BioActor

Maastricht, 6229GS, Netherlands

Location

Related Publications (1)

• Bednarska K, Fecka I, Scheijen JLJM, Ahles S, Vangrieken P, Schalkwijk CG. A Citrus and Pomegranate Complex Reduces Methylglyoxal in Healthy Elderly Subjects: Secondary Analysis of a Double-Blind Randomized Cross-Over Clinical Trial. Int J Mol Sci. 2023 Aug 24;24(17):13168. doi: 10.3390/ijms241713168.

  PMID: 37685975 DERIVED

Study Officials

• Freddy Troost, Dr

  Maastricht University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 10, 2018
• First Posted: December 20, 2018
• Study Start: June 25, 2018
• Primary Completion: January 17, 2019
• Study Completion: January 17, 2019
• Last Updated: June 24, 2019

Record last verified: 2019-06

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)