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Effect of an Anti-ageing Supplement on Oxidative Stress (PromAge)

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ClinicalTrials.gov Identifier: NCT03272867
Recruitment Status : Completed
First Posted : September 6, 2017
Last Update Posted : September 6, 2017
Sponsor:
Information provided by (Responsible Party):
Prof. dr. S.J.L. Bakker, MD, PhD, University Medical Center Groningen

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 challenge tests will be assessed in subjects taking ProManna versus placebo supplements.

Condition or disease Intervention/treatment Phase
Healthy Volunteers Age Group: 60-70 Overweight Dietary Supplement: ProManna Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: 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)
Actual Study Start Date : December 2014
Actual Primary Completion Date : February 2016
Actual Study Completion Date : June 2016

Resource links provided by the National Library of Medicine


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
Dietary Supplement: ProManna
Other Names:
  • L-proline
  • D-mannitol

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
Dietary Supplement: ProManna
Other Names:
  • L-proline
  • D-mannitol




Primary Outcome Measures :
  1. Changes in oxidative stress markers [ Time Frame: Two weeks ]
  2. Changes in oxidative stress following a hyperoxia or glucose challenge [ Time Frame: Two weeks ]

Secondary Outcome Measures :
  1. Changes in experienced health [ Time Frame: Two weeks ]
    Rand-36-item Health Survey (SF-36)



Information from the National Library of Medicine

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Ages Eligible for Study:   60 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion 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:

  1. BMI < 25 or > 30 kg/m2
  2. Not being able to fast overnight (12 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03272867


Locations
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Netherlands
UMCG
Groningen, Netherlands, 9700RB
Sponsors and Collaborators
University Medical Center Groningen

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Responsible Party: Prof. dr. S.J.L. Bakker, MD, PhD, Prof. dr., University Medical Center Groningen
ClinicalTrials.gov Identifier: NCT03272867     History of Changes
Other Study ID Numbers: 14TGO01
First Posted: September 6, 2017    Key Record Dates
Last Update Posted: September 6, 2017
Last Verified: September 2017

Additional relevant MeSH terms:
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Overweight
Body Weight
Signs and Symptoms