The Effect of a Combination of Orange- and Pomegranate Ac... | NCT03781999

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

NCT03781999

Sponsor

BioActor

Status

Completed

Last Update Posted

Jun 24, 2019Actual

Enrollment

37Actual

Phase

Not Applicable

Conditions

Fitness

Interventions

Actiful
Placebo

Countries

Netherlands

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2019

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 25, 2018Actual

Primary Completion Date

Jan 17, 2019Actual

Completion Date

Jan 17, 2019Actual

First Submitted Date

Dec 10, 2018

First Submission Date that Met QC Criteria

Dec 18, 2018

First Posted Date

Dec 20, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 20, 2019

Last Update Posted Date

Jun 24, 2019Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

37Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Actiful	Experimental	a supplement containing 500 mg orange extract and 200 mg pomegranate actives	Dietary Supplement: Actiful
Placebo	Placebo Comparator	Maltodextrin	Other: Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Actiful	Dietary Supplement	supplement containing 500 mg orange extract and 200 mg pomegranate actives	Actiful

Outcomes Module

Primary Outcomes

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 Outcomes

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

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

60 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Freddy Troost, Dr	Maastricht University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
BioActor		Maastricht		6229GS	Netherlands

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
37685975	Derived	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.