NL-OMON40413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) - Effect of an anti-ageing supplement on oxidative stress
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •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.
排除标准
- •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
研究者
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