- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03272867
Effect of an Anti-ageing Supplement on Oxidative Stress (PromAge)
September 2, 2017 updated by: Prof. dr. S.J.L. Bakker, MD, PhD, University Medical Center Groningen
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)
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 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. 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 Type
Interventional
Enrollment (Actual)
20
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Groningen, Netherlands, 9700RB
- UMCG
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
60 years to 70 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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 Criteria:
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: PREVENTION
- Allocation: RANDOMIZED
- Interventional Model: CROSSOVER
- Masking: QUADRUPLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Intervention group
One group of volunteers will ingest a powder with dose of 6.1 g ProManna twice a day for a period of 2 weeks
|
Other Names:
|
PLACEBO_COMPARATOR: Control group
Another group of volunteers will ingest a powder with the same amount of a placebo twice a day for a periode of 2 weeks
|
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Changes in oxidative stress markers
Time Frame: Two weeks
|
Two weeks
|
Changes in oxidative stress following a hyperoxia or glucose challenge
Time Frame: Two weeks
|
Two weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Changes in experienced health
Time Frame: Two weeks
|
Rand-36-item Health Survey (SF-36)
|
Two weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
December 1, 2014
Primary Completion (ACTUAL)
February 1, 2016
Study Completion (ACTUAL)
June 1, 2016
Study Registration Dates
First Submitted
September 2, 2017
First Submitted That Met QC Criteria
September 2, 2017
First Posted (ACTUAL)
September 6, 2017
Study Record Updates
Last Update Posted (ACTUAL)
September 6, 2017
Last Update Submitted That Met QC Criteria
September 2, 2017
Last Verified
September 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 14TGO01
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Overweight
-
University Hospital, LilleNational Research Agency, France; European Union; University of Lille Nord de... and other collaboratorsNot yet recruitingOverweight and Obesity | Overweight, Childhood | Overweight, Infant
-
Children's Hospital Los AngelesUniversity of Southern California; Tufts Medical CenterRecruitingOverweight and Obesity | Overweight AdolescentsUnited States
-
University of AarhusThe Danish Dairy Research Foundation, Denmark; Sygekassernes HelsefondCompletedOverweight and Obesity | Overweight Adolescents | Metabolic DiseaseDenmark
-
Memorial Sloan Kettering Cancer CenterRecruitingObesity | Overweight | Overweight and Obesity | Obese | Overweight or ObesityUnited States
-
University Hospital Bispebjerg and FrederiksbergUniversity of CopenhagenCompleted
-
Holbaek SygehusUniversity of Copenhagen; University of Florida; University of Minnesota; Hebrew... and other collaboratorsRecruitingChildhood Overweight and ObesityDenmark
-
Khyber Medical University PeshawarRecruitingObesity, OverweightPakistan
-
National Taiwan University HospitalCompleted
-
Institut Investigacio Sanitaria Pere VirgiliCompletedObesity, Childhood | Overweight and Obesity | Overweight, ChildhoodSpain
-
Children's Hospital SrebrnjakBelupo; Podravka d.d.RecruitingBody Weight | Overweight and ObesityCroatia