Acute Effects of Water Extract of Crocus Sativus Tepals on Metabolic Health Parameters in Patients With Obesity and Prediabetes
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- glucose levels
研究概览
简要总结
The goal of this clinical trial is to determine the acute effects of ingestion of a cold aqueous extract of Crocus sativus tepals on postprandial glycemia and other indicators of metabolic health in patients with obesity and/or prediabetes. The main questions it aims to answer are:
- Does the ingestion of Crocus sativus tepals cold aqueous extract prior to a meal improve the glycemic response to a standard meal?
- How does the ingestion of Crocus sativus tepals aqueous extract prior to a meal impact insulin levels and other markers of metabolic health?
- Does the ingestion of Crocus sativus tepals cold aqueous extract prior to a meal increase the resting energy expanditure?
Researchers will compare Crocus sativus tepals cold aqueous extract to cold water.
The participants will visit the Faculty twice - on one visit they will ingest Crocus sativus tepals cold aqueous extract and on the other cold water (in random order) 5 minutes prior to a standard meal of 100 g of white bread.
On each visit, anthropometric measurements will be performed upon arrival. Blood samples will be collected 3 times, preceeded by resting metabolic rate and blood pressure measurements: at baseline in fasted conditions, and 60 minutes and 120 minutes after consuming the bread.
There will be an at least 7 days wash-out period between the two visits.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Obesity type I (ITM > 30 kg/m2) and/or
- •Prediabetes (fasting glucose levels 6,1 - 6,9 mmol/L)
排除标准
- •Gastrointestinal diseases
- •Diabetes mellitus of any type
- •Pregnant or lactating, without contraception
- •Serious clinical conditions such as cancer, severe infections, severe psychiatric disorders, autoimmune diseases, inflammatory diseases
- •Participation in another clinical trial 3 months prior to the study
- •ITM greater than 35 kg/m2
- •Celiac disease of gluten intolerance
- •electronic implant
研究组 & 干预措施
Crocus sativus
Crocus sativus tepals cold aqueous extract
干预措施: Crocus sativus tepals cold aqueous extract (Biological)
water
cold water
干预措施: cold water (Biological)
结局指标
主要结局
glucose levels
时间窗: From enrollment to the end of second measurement at 2 weeks
Serum glucose levels will be measured from venous blood at baseline and 60 and 120 minutes after bread ingestion.
次要结局
- insulin level(From enrollment to the end of second measurement at 2 weeks.)
- Resting metabolism(From enrollment to the end of the second measurement, at 2 weeks)
- Blood pressure(baseline, 60 minutes after bread ingestion, 120 minutes after bread ingestion)
研究者
Nina Mohorko
Associate professor
University of Primorska