Status:
COMPLETED
Effect of an Anti-ageing Supplement on Oxidative Stress
Lead Sponsor:
University Medical Center Groningen
Conditions:
Healthy Volunteers
Age Group: 60-70
Eligibility:
All Genders
60-70 years
Phase:
NA
Brief Summary
This pilot study serves to investigate whether ProManna intake leads to any changes in baseline levels for oxidative stress markers. In addition, biomarker responses following oxidative stress challen...
Detailed Description
Ageing is characterized by a progressive decline in the efficiency of physiological function and by the increased susceptibility to disease and death. Most ageing-associated diseases develop silently ...
Eligibility Criteria
Inclusion
- Healthy volunteer aged ≥ 60 to ≤ 70
- Not involved in intensive sportive activities more than twice a week (e.g. playing football, tennis, running, cycling-racing, swimming)
- Stable weight and no intention to lose weight until completion of the study (three times a day: a normal eating pattern).
- Two weeks before the start and during the study no use of over the counter medication, prescribed medication, herbal medication or dietary supplements which in the investigator's opinion could affect study results, or which could be affected by the study product (i.e. absorption of oral medication will be influenced by D-Mannitol). Exception for sporadic use of paracetamol and/or treating an AE.
- Able and motivated to comply with protocol requirements like for instance take the investigational product the way it is prescribed and to do the tests.
- Voluntary signed written informed consent form (ICF) before the start of the pilot.
Exclusion
- BMI \< 25 or \> 30 kg/m2
- Not being able to fast overnight (12 hours)
- Diabetes mellitus
- Gastrointestinal disorders
- Undergone digestive tract surgery (except appendectomy)
- Clinically significant inflammatory disease (possibly interfering with measurement of parameters in this study)
- Weed smoking
- Donation of blood within the last 3 months prior to admission to the clinic
- Participation to another clinical study within 90 days before enrolment
- Clinically relevant abnormalities in clinical chemistry or positive HIV, HbsAg and/or HepC at screening
- Positive drug screen or alcohol breath test at D-1
Key Trial Info
Start Date :
December 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2016
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT03272867
Start Date
December 1 2014
End Date
June 1 2016
Last Update
September 6 2017
Active Locations (1)
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1
UMCG
Groningen, Netherlands, 9700RB