Cross-over randomized placebo-controlled pilot study to determine the effect in healthy elderly volunteers of the anti-ageing supplement *Promanna** on a number of biomarkers associated with DNA-damage and oxidative stress (PromAge)
- Conditions
- iet van toepassing, het gaat om gezonde vrijwilligers.NA (this is about healthy ageing)
- Registration Number
- NL-OMON40413
- Lead Sponsor
- niversitair Medisch Centrum Groningen
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 20
In order to be eligible to participate in this study, a subject must meet all of the following criteria:
1. Healthy volunteer aged >= 60 to <= 70
2. Not involved in intensive sportive activities more than twice a week (e.g. playing football, tennis, running, cycling-racing, swimming)
3. Stable weight and no intention to lose weight until completion of the study (three times a day: a normal eating pattern).
4. 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.
5. 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.
6. Voluntary signed written informed consent form (ICF) before the start of the pilot.
A potential subject who meets any of the following criteria will be excluded from participation in this study:
1. BMI < 25 or > 30 kg/m2
2. Not being able to fast overnight (8 hours)
3. Diabetes mellitus
4. Gastrointestinal disorders
5. Undergone digestive tract surgery (except appendectomy)
6. Clinically significant inflammatory disease (possibly interfering with measurement of parameters in this study)
7. Weed smoking
8. Donation of blood within the last 3 months prior to admission to the clinic
9. Participation to another clinical study within 90 days before enrolment
10. Clinically relevant abnormalities in clinical chemistry or positive HIV, HbsAg and/or HepC at screening
11. Positive drug screen or alcohol breath test at D-1
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The main study parameters are:<br /><br>• Changes in baseline levels for oxidative stress markers following 2 weeks<br /><br>intake of ProManna versus placebo<br /><br>• Comparison of oxidative stress responses following a hyperoxia or glucose<br /><br>challenge in subjects taking ProManna or placebo.</p><br>
- Secondary Outcome Measures
Name Time Method <p>Results from questionnaires and biomarker studies will be used to design a<br /><br>long-term intervention study that will investigate the effect of ProManna on<br /><br>physical and mental parameters. </p><br>