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临床试验/NCT03272867
NCT03272867已完成不适用

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)

University Medical Center Groningen2 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2014年12月最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
20
试验地点
2
主要终点
Changes in oxidative stress markers

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Prevention
盲法
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
60 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

  • 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

研究组 & 干预措施

Intervention group

Experimental

One group of volunteers will ingest a powder with dose of 6.1 g ProManna twice a day for a period of 2 weeks

干预措施: ProManna (Dietary Supplement)

Control group

Placebo Comparator

Another group of volunteers will ingest a powder with the same amount of a placebo twice a day for a periode of 2 weeks

干预措施: ProManna (Dietary Supplement)

结局指标

主要结局

Changes in oxidative stress markers

时间窗: Two weeks

Changes in oxidative stress following a hyperoxia or glucose challenge

时间窗: Two weeks

次要结局

  • Changes in experienced health(Two weeks)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Prof. dr. S.J.L. Bakker, MD, PhD

Prof. dr.

University Medical Center Groningen

研究点 (2)

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