Determining the effect of short term ProManna intake on physiological parameters, notably biomarkers of oxidative stress. This pilot study serves to investigate whether ProManna intake leads to any changes in baseline levels for oxidative stress…
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
Niet van toepassing, het gaat om gezonde vrijwilligers.
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The main study parameters are:
• Changes in baseline levels for oxidative stress markers following 2 weeks
intake of ProManna versus placebo
• Comparison of oxidative stress responses following a hyperoxia or glucose
challenge in subjects taking ProManna or placebo.
Secondary outcome
Results from questionnaires and biomarker studies will be used to design a
long-term intervention study that will investigate the effect of ProManna on
physical and mental parameters.
Background summary
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 for many years before
symptoms appear, leading to irreversible pathological conditions. Examples of
these diseases are Alzheimer*s, Parkinson*s, osteoporosis, diabetes,
cardiovascular disease and also cancer. Typically, patients are treated when
most of the damage has already occurred, and existing drugs can rarely cure
these diseases, but merely slow down further progression of the disease.
Therefore, preventive measures that may delay the onset of these diseases can
hold the best promise for healthy ageing.
Currently, one of the most plausible and acceptable explanations for the
mechanistic basis of aging is the *free radical theory of aging*. This theory
postulates that aging and its related diseases are the consequence of free
radical-induced damage to cellular macromolecules and the inability to
counterbalance these changes by endogenous anti-oxidant defences. ProManna is a
novel and safe food supplement that aims to decrease free radical-induced
damage, thereby contributing to healthy ageing.
Study objective
Determining the effect of short term ProManna intake on physiological
parameters, notably biomarkers of oxidative stress. 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 challenge tests will be assessed in subjects taking ProManna versus
placebo supplements. Results from this study will be used to set up a long term
clinical study that will investigate the effect of ProManna supplementation on
physical and mental parameters of elderly.
Study design
a randomized, placebo-controlled cross-over study.
Intervention
Use of ProManna for two weeks.
Study burden and risks
This is a non-therapeutic study with healthy volunteers. The investigational
product is a safe food supplement and administration is oral and burden-free.
There is a small chance that some participants may develop mild diarrhoea
during the first days after ProManna intake but earlier studies showed that
this is only transient. Participants will be required to provide small volumes
of blood and urine for baseline testing and to complete questionnaires.
Participants attend baseline measurements before the study and before the start
of the second study period after cross over. The baseline consists of a short
visit to the research lab, getting information about the study and giving a
blood sample. Besides that, there will be a total of 4 test days of one morning
per participant, and prior to test day 1 and 3, participants are asked to
collect 24h urine samples. Tests consist of hyperoxia and oral glucose
tolerance testing followed by blood sampling. During blood-sampling there is a
small chance of bleeding at the puncture site, fainting or light skin
infection. The physical examination is relatively simple, carried out by
trained research nurses and is not very stressful for participants. Mentioned
risks are rare if performed by qualified personnel at UMCG
Anthonius Deusinglaan 1
Groningen 9713 AV
NL
Anthonius Deusinglaan 1
Groningen 9713 AV
NL
Listed location countries
Age
Inclusion criteria
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.
Exclusion criteria
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
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL47431.042.14 |