NCT04160312已完成不适用
Open-labelled, Crossover and Randomized Study With Mitopure™ (Proprietary Urolithin A) Dietary Supplementation Compared to Pomegranate Juice Intake: A Bioavailability Study in Healthy Adults (NOURISH)
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Amazentis SA
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Absolute change from T0 to T+24 hours in the Urolithin A (UA) group as compared to Pomegranate Juice (PJ) group in UA- glucuronide plasma levels.
研究概览
简要总结
This is a single-center, two-period, crossover, randomized, open labelled study enrolling 100 healthy subjects to evaluate the Urolithin A producer status and to compare bioavailabilty of direct dietary supplementation with Mitopure™ (proprietary Urolithin A) to dietary exposure with pomegranate juice
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Males and females 18 to 80 years of age;
- •Is in general good health, as determined by the clinical research team;
- •Willingness to consume investigational product, complete questionnaires and to complete all clinic visits;
- •Have given voluntary, written, informed consent to participant in the study;
排除标准
- •Women who are pregnant, breastfeeding, or planning to become pregnant during the course of the trial;
- •Alcohol or drug abuse within the last 6 months;
- •Volunteers who plan to donate blood during the study or within 30 days of completing the study;
- •Subject has a known allergy to the test material's active or inactive ingredients;
- •Subjects with unstable medical conditions;
- •Clinically significant abnormal laboratory results at screening;
- •Participation in a clinical research trial within 30 days prior to randomization;
- •Allergy or sensitivity to study ingredients; lactose intolerance.
- •Individuals who are cognitively impaired and/or who are unable to give informed consent;
- •Any other condition which in the Investigator's opinion may adversely affect the subject's ability to complete the study or its measures or which may pose significant risk to the subject.
- •Has taken antibiotics within the previous 30 days;
研究组 & 干预措施
Mitopure™ (Proprietary Urolithin A)
Experimental
Fruit flavored food sachet containing fixed dose of Mitopure™ (Proprietary Urolithin A)
干预措施: Mitopure™ (Proprietary Urolithin A) (Dietary Supplement)
Pomegranate Juice
Experimental
100% Pomegranate juice equivalent to a glass of juice
干预措施: Pomegranate Juice (Dietary Supplement)
结局指标
主要结局
Absolute change from T0 to T+24 hours in the Urolithin A (UA) group as compared to Pomegranate Juice (PJ) group in UA- glucuronide plasma levels.
时间窗: 2 days
次要结局
- Absolute change from T0 to T+24 hours in the UA group as compared to PJ group in UA- glucuronide blood spot levels(2 days)
- Absolute change from T0 to T+6 hours in the UA group as compared to PJ group in UA- glucuronide blood spot levels.(1 day)
- Change in AUC from T0 to T+6 and/or T+24 in the UA group as compared to the PJ group in UA glucuronide levels(2 days)
- Differences between UA producers and non-producers at baseline for Hand grip strength using a calibrated JAMAR® Hydraulic Hand Dynamometer(2 days)
- Differences between UA producers and non-producers at baseline for gut microbiome. Fecal samples will be used to extract DNA and shotgun sequencing will be performed to assess global microbiome differences at the species level.(2 days)
- Differences between UA producers and non-producers at baseline for plasma metabolome. Metabolites in serum will be measured by metabolomic mass spectrometry(2 days)
- Differences in consumer perception on the study investigation food products overall taste using a consumer perception Likert scale(1 day)
- Absolute change from T0 to T+6 hours in the UA group as compared to PJ group in UA- glucuronide plasma levels.(1 day)
- Change in AUC from T0 to T6 hours and/or to T24 hours in the UA group as compared to PJ group in UA sulfate plasma levels(2 days)
- Absolute change from T0 to T6 hours and/or to T24 hours in the UA group as compared to PJ group in UA aglycone (parent) plasma levels(2 days)
- Change in AUC from T0 to T+6 and/or T+24 in the UA group as compared to the PJ group in UA aglycone (parent) plasma levels(2 days)
- Absolute change from T0 to T6 hours and/or to T24 hours in the UA group as compared to PJ group in UA sulfate plasma levels(2 days)
- To assess prevalence of UA producers following consumption of fixed volume of Pomegranate juice in a healthy US population(2 days)
- Differences between UA producers and non-producers at baseline for gait speed using the 4-meter gait speed test(2 days)
- Differences between UA producers and non-producers at baseline for physical activity levels assessed via the International Physical Activity Questionnaire.(2 days)
- Differences between UA producers and non-producers at baseline for energy levels assessed via the Lee-Visual Analogue Scale to assess Fatigue (VAS-F).(2 days)
- Differences between UA producers and non-producers at baseline for blood biochemistry metabolic profile as assessed via lipid profile in plasma.(2 days)
研究者
研究点 (1)
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