Exploring Unconventional Plant-Derived Metabolites for Glycemic Control: the Case of Pomegranate
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Targeted metabolites - urolithins profiling
研究概览
简要总结
The EXPLORER study will investigate whether supplementation with a pomegranate extract rich in ellagitannins is able to improve well-being and metabolic health in individuals without diabetes. The aim is to establish for the first time an association between the intake of ellagitanninsa and glycaemic control, the processing/aggregation of IAPP (a protein associated with diabetes), the state of the intestinal microbiota and circulating levels of urolithin B (a small bioavailable molecule resulting from the metabolism of ellagitannins).
This is a 12-week pilot study that is double-blind (neither participants nor researchers know who gets the treatment) and placebo-controlled (some people will receive a non-active substance). It will involve volunteers who do not have diabetes.
Phase 1 - Recruitment: Volunteers without diabetes, who are patients at a family health unit, will be recruited. Participants will provide informed consent and information such as sociodemographic and biochemical data.
Phase 2 - Intervention: The recruited individuals will be divided into two groups: one receiving the pomegranate extract supplement (intervention group) and the other receiving a placebo. In total, 60 participants will take part in the study.
详细描述
A double-blinded, randomized, placebo-controlled pilot study was designed to assess the effect of Ellagitannins Pomegranate Supplements (EPS) in metabolic health of participants.
Participants will be recruited at the family health unit USF São Martinho de Alcabideche from the grouping of health centres ACES Cascais, and the study will be conducted according to universal bioethical principles.
At least 60 individuals with pre-diabetes will be included in the study. After the fulfilment of the inclusion criteria, they will be randomly assigned to the intervention group (IG) and the placebo group (PG). Equal distribution of gender, age and BMI will be ensured between the groups.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Individuals without diabetes
- •Both sexes
- •Aged between 18 and 65
- •Body Mass Index (BMI) less than 29.9 kg/m2
- •Fasting plasma glucose levels below 126 mg/dL
- •Haemoglobin A1C levels between 5.7 - 6.5%
排除标准
- •Not agreeing to take part in the study
- •BMI>30 kg/m2
- •Being diagnosed with diabetes
- •Having any type of cognitive disorder
- •Using anti-diabetic medication
- •Alcohol or drug abuse
- •Pomegranate allergy
- •Regular use of food supplements
- •Difficulty swallowing tablets
- •Being on, or planning to be on during the study period, a different diet than usual
- •Pregnancy, planning to become pregnant during the study, breastfeeding 1 year before or during the study
- •Oncological, cardiac, hepatic, renal, thyroid or other endocrine diseases
- •Medical or social conditions that may affect adherence
- •Participating in another study at the same time.
结局指标
主要结局
Targeted metabolites - urolithins profiling
时间窗: 12 weeks
Urine sample
pro-IAPP
时间窗: 12 weeks
Blood sample
IAPP (Islet Amiloide Polipeptide)
时间窗: 12 weeks
Boold sample
次要结局
- Short-chain fatty acids profiling(12 weeks)
研究者
Regina Menezes
Principal Investigator
Lusofona University