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

Fitness Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03781999
• Other study ID #: Actiful_001
• Status: Completed
• Phase: N/A
• Start date: June 25, 2018
• Est. completion date: January 17, 2019

Study information

• Verified date: June 2019
• Source: BioActor
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 37
• Est. completion date: January 17, 2019
• Est. primary completion date: January 17, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 60 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Fitness

Intervention

Dietary Supplement:
• Actiful
supplement containing 500 mg orange extract and 200 mg pomegranate actives

Other:
• Placebo
Maltodextrin

Locations

Country	Name	City	State
Netherlands	BioActor	Maastricht

Sponsors (1)

Lead Sponsor	Collaborator
BioActor

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Senior Fitness test	Fitness tests to see if Actiful improves physical activity level	0-4-8-12 weeks
Secondary	Daily physical activity measured by accelerometers	Accelerometer is worn for 7 days prior to each testing day	0-4-8-12 weeks
Secondary	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)	0-4-8-12 weeks
Secondary	Concentration of blood marker TAC	Total antioxidant capacity measurement in plasma	0-4-8-12 weeks