Randomized Clinical Trial on the Effect of a Nutritional Product Containing Carob Extract (NUTIFOOD) on Carbohydrate Metabolism in Glucose-intolerant Subjects
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Glycated Hemoglobin (HbA1c)
研究概览
简要总结
Randomized, controlled, double-blind clinical trial with two parallel arms based on the product consumed (experimental product and placebo product) and conducted at a single center, to measure the efficacy of the liquid NUTIFOOD product (nutritional product with carob extract) on carbohydrate metabolism.
详细描述
This study evaluates the effects of NUTIFOOD (liquid nutritional product with carob extract) on insulin sensitivity and carbohydrate metabolism in subjects with abnormal glucose or HbA1c levels not on antidiabetic medication, over 90 days.
Key assessments include: Glucose response (AUC and peak levels) during an oral glucose tolerance test. Changes in fasting glucose, HbA1c, and basal insulin. Insulin resistance measured by HOMA-IR and QUICKI. Effects on body composition. Safety and tolerability of the product.
The study aims to determine the potential of NUTIFOOD as a nutritional intervention to improve glucose regulation and metabolic health.
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
- Single (Investigator)
盲法说明
Double-blind study. The organoleptic characteristics of the experimental product and the placebo will be identical.
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
- •Subjects of both sexes aged 18-65 years.
- •Diagnosis of glucose intolerance according to the American Diabetes Association (at least one of the following criteria):
- •Impaired fasting glucose (100-125 mg/dl)
- •Impaired glucose tolerance (oral glucose tolerance test with 2-hour plasma glucose between 140-199 mg/dl)
- •Glycated hemoglobin between 5.7% and 6.4%
- •Body mass index between 20-35 kg/m².
- •Stable dietary habits: no weight gain or loss greater than 5 kg in the last ten weeks.
- •Volunteers capable of understanding the clinical study and willing to comply with the study procedures and requirements.
排除标准
- •Use of medications that may interfere with glucose metabolism.
- •Subjects with a history of any type of hepatic or renal disease.
- •Alcohol consumption greater than 20 g/day.
- •History of allergic hypersensitivity or poor tolerance to any component of the study products.
- •Participation in another clinical trial within the three months prior to the study.
- •Lack of willingness or inability to comply with clinical trial procedures.
- •Pregnant or breastfeeding women.
研究组 & 干预措施
Carob liquid - GippsNature
Participants will consume two daily doses of the experimental product (liquid carob extract) for 90 days.
干预措施: Experimental Product (Dietary Supplement)
Placebo
Participants will consume two daily doses of a placebo product with the same organoleptic characteristics as the experimental product for 90 days.
干预措施: Control product (Dietary Supplement)
结局指标
主要结局
Glycated Hemoglobin (HbA1c)
时间窗: Measurements will be performed at baseline, Day 45, and Day 90
Fasting glycated hemoglobin (HbA1c) will be measured in venous blood samples to assess long-term glycemic control.
Area Under the Curve (AUC) of Blood Glucose During Oral Glucose Tolerance Test
时间窗: This assessment will be conducted at baseline, Day 45, and Day 90.
The area under the curve (AUC) of blood glucose will be calculated during an oral glucose tolerance test (OGTT) using a 50-g glucose load. Capillary blood glucose levels will be measured at 0, 15, 30, 45, 60, 90, and 120 minutes after glucose ingestion.
次要结局
- Fasting and Post-Load Insulinemia(These measurements will be performed at baseline, Day 45, and Day 90.)
- Insulin Resistance(They will be calculated at the start of the study, on day 45, and on day 90.)
- Insulin Sensitivity(It will be calculated at the start of the study, on day 45, and on day 90.)
- Body Composition Analysis(These measurements will be performed at baseline, Day 45, and Day 90.)
- Liver safety variables(These measurements will be performed at baseline, on day 45, and on day 90.)
- Adverse events(At 12 weeks after consumption)
研究者
Francisco Javier López Román
Principal Investigator
Universidad Católica San Antonio de Murcia