The Effect of a Combination of Orange- and Pomegranate Actives on Physical Fitness in Elderly People
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|ClinicalTrials.gov Identifier: NCT03781999|
Recruitment Status : Completed
First Posted : December 20, 2018
Last Update Posted : June 24, 2019
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|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||37 participants|
|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|
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
- 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.
- Senior Fitness test [ Time Frame: 0-4-8-12 weeks ]Fitness tests to see if Actiful improves physical activity level
- Daily physical activity measured by accelerometers [ Time Frame: 0-4-8-12 weeks ]Accelerometer is worn for 7 days prior to each testing day
- 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)
- Concentration of blood marker TAC [ Time Frame: 0-4-8-12 weeks ]Total antioxidant capacity measurement in plasma
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03781999
|Maastricht, Netherlands, 6229GS|
|Principal Investigator:||Freddy Troost, Dr||Maastricht University|