FitnessNCT03781999
The Effect of a Combination of Orange- and Pomegranate Actives on Physical Fitness in Elderly People
A study testing Actiful in people with Fitness, run by BioActor at 1 site in Netherlands.
Trial 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. Read more about this study
- Who is it for?
- Ages 60 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Fitness
- What is being tested?
- Actiful
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 37 participants
- Where
- 1 siteNetherlands
- Study dates
- 25 Jun 2018to 17 Jan 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 60 - 75 years old
- non smoking
- BMI 18 -28 kg/m²
Who cannot join
- 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)
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
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).
Read the 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.
- Conditions
- Fitness
- Being tested
- Actiful, Placebo
- Keywords
- Performance, Polyphenols, Nutrition, Sports
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ActifulDietary supplement
supplement containing 500 mg orange extract and 200 mg pomegranate actives
PlaceboOther
Maltodextrin
| Study group | Role | What they receive |
|---|---|---|
| Actiful | Experimental | a supplement containing 500 mg orange extract and 200 mg pomegranate actives Receives: Dietary Supplement: Actiful |
| Placebo | Placebo comparator | Maltodextrin Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
6 Minute Walking Test
Participants have to walk for 6 minutes, as fast as possible. Total distance will be measured.
Measured: 0-4-8-12 weeks
Secondary outcomes (4)
Senior Fitness test
Fitness tests to see if Actiful improves physical activity level
Measured: 0-4-8-12 weeks
Daily physical activity measured by accelerometers
Accelerometer is worn for 7 days prior to each testing day
Measured: 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)
Measured: 0-4-8-12 weeks
Concentration of blood marker TAC
Total antioxidant capacity measurement in plasma
Measured: 0-4-8-12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2018
- Study start25 Jun 2018
- Primary completion17 Jan 2019
- Study completion17 Jan 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for FitnessStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 37 participants (actual)
Sponsor and investigators
- Lead sponsor
- BioActor
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Freddy Troost, Dr, Principal investigator, Maastricht University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03781999
- Sponsor's protocol ID
- Actiful_001
- Status last verified
- Jun 2019
- First submitted
- 10 Dec 2018
- Last updated
- 24 Jun 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 37685975
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of a Combination of Orange- and Pomegranate Actives on Physical Fitness in Elderly People
- ClinicalTrials.gov ID
- NCT03781999
- Acronym / sponsor ID
- Actiful_001
- Conditions
- Fitness
- Keywords
- Performance, Polyphenols, Nutrition, Sports
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 37 participants (actual)
- Lead sponsor
- BioActorIndustry (pharma, biotech, devices)
- Study start
- 25 Jun 2018 (actual)
- Primary completion
- 17 Jan 2019 (actual)
- Study completion
- 17 Jan 2019 (actual)
- First posted
- 20 Dec 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Actiful | Experimental | Dietary Supplement: Actifula supplement containing 500 mg orange extract and 200 mg pomegranate actives |
| Placebo | Placebo comparator | Other: PlaceboMaltodextrin |
Who may qualify
- Ages
- 60 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 60 - 75 years old
- non smoking
- BMI 18 -28 kg/m²
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Actifulsupplement containing 500 mg orange extract and 200 mg pomegranate actives | Dietary supplement | Actiful |
| PlaceboMaltodextrin | Other | Placebo |
Primary outcome
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.
4 secondary outcomes
Senior Fitness test
Time frame: 0-4-8-12 weeks
Daily physical activity measured by accelerometers
Time frame: 0-4-8-12 weeks
Quality of life questionnaire - WHOQOL-100
Time frame: 0-4-8-12 weeks
Concentration of blood marker TAC
Time frame: 0-4-8-12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2019.
- Derived from this study: PubMed 37685975Bednarska 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Freddy Troost, Dr principal investigator
Maastricht University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Actiful in people with Fitness, run by BioActor at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
6 Minute Walking Test (time frame: 0-4-8-12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03781999, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jun 2019.