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Completed

NCT Number: NCT03272867

Effect of an Anti-ageing Supplement on 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.

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Key information

Age range

60 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

UMCG

Groningen, 9700RB, Netherlands

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ProManna

Dietary Supplement

Other names: L-proline, D-mannitol

Primary outcomes

  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 outcomes

  1. Changes in experienced health

    Time frame: Two weeks

    Rand-36-item Health Survey (SF-36)

Sponsors and collaborators

Lead sponsor

University Medical Center Groningen

Other

Registry information

Official study 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)

Acronym: PromAge

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Sep 6, 2017
Registry last updated
Sep 6, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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