A Multicentre, Double Blind, Placebo Controlled, Clinical Trial to Investigate the Effects and Tolerability of 7-Ketolithocholic Acid, a Novel Food, Associated to Diet and Physical Activity, in Lowering Fasting Plasma Glucose (FPG) Levels in Subjects With Pre-diabetes.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 100
- 试验地点
- 6
- 主要终点
- Mean change in Fasting Plasma Glucose (FPG)
研究概览
简要总结
7-Ketolithocholic Acid, a naturally occurring bile acid, is a novel food currently under investigation for potential metabolic benefits, including glucose-lowering effects. This study aims to evaluate the efficacy and safety of 7-Ketolithocholic Acid, administered alongside a low-glycaemic, hypocaloric diet, and increased physical activity in reducing fasting plasma glucose and other metabolic parameters in subjects with prediabetes. Demonstrating a clinically meaningful glucose-lowering effect would support its potential role in early intervention to prevent or delay the onset of type 2 diabetes.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male and female participants aged ≥18 years and ≤70 years.
- •Ability and willingness to provide written informed consent.
- •Diagnosis of prediabetes, defined by the following metabolic criteria:
- •Impaired fasting glucose (IFG): fasting plasma glucose levels between 100 and 125 mg/dL.
- •Impaired glucose tolerance (IGT): plasma glucose levels between 140 and 199 mg/dL measured 2 hours after a standard oral glucose tolerance test (OGTT).
- •Elevated HbA1c: HbA1c values between 5.7% and 6.4% (or 42 and 47 mmol/mol).
- •Body mass index (BMI) in the range 25-31 kg/m2 (inclusive).
- •Willingness to strictly comply with a low-glycaemic, hypocaloric diet during the study period and maintain a food diary.
- •Willingness to comply with recommended physical activity during the study period and maintain an activity diary.
- •Women of childbearing potential must agree to not become pregnant during the study and to use effective contraception (according to Recommendations related to contraception and pregnancy testing in clinical trials.
排除标准
- •Previous or current diagnosis of diabetes mellitus.
- •Presence of hypertension, defined as blood pressure >130/85 mmHg.
- •Hypertriglyceridemia, defined as fasting blood triglyceride levels ≥ 200 mg/dL.
- •LDL cholesterol ≥ 190 mg/dL.
- •Current treatment with oral hypoglycaemic agents or use of supplements with hypoglycaemic effects.
- •Use of any medication (self-medication or prescription medication) or supplementation potentially acting on glucose and lipid parameters within 28 days before entry in the study (or at least 5 times the respective elimination half-life, whichever is longer).
- •Any medical condition or treatment that, in the opinion of the investigator, could interfere with the study outcomes or participant safety.
- •Use of vitamin K antagonist anticoagulant drugs (such as warfarin).
- •Pregnancy or breast-feeding.
- •Any other condition that would preclude adherence to the study protocol or informed consent process, including, but not limited, to active or uncontrolled metabolic, endocrine, cardiovascular, renal, hepatic, pulmonary, gastrointestinal, neurological, endocrinological, immunological, or psychiatric disease.
- •Subjects with any history of hypersensitivity to the product under study or its excipients (please refer to Appendix B for listing of ingredients).
研究组 & 干预措施
7-KLCA
Coated tablets containing 400 mg of 7-Ketolithocholic Acid, taken once daily in tablet form.
干预措施: 7-KLCA (Dietary Supplement)
7-KLCA
Coated tablets containing 400 mg of 7-Ketolithocholic Acid, taken once daily in tablet form.
干预措施: Diet and Physical Activity (Other)
Placebo
Placebo tablets with the same aspect and composition of active comparator but not containing any active ingredient (no 7-KLCA), taken once daily in tablet form.
干预措施: Placebo (Dietary Supplement)
Placebo
Placebo tablets with the same aspect and composition of active comparator but not containing any active ingredient (no 7-KLCA), taken once daily in tablet form.
干预措施: Diet and Physical Activity (Other)
结局指标
主要结局
Mean change in Fasting Plasma Glucose (FPG)
时间窗: Baseline and Week 12
Difference in the mean change in fasting plasma glucose (FPG) from baseline to Week 12 between the treatment and placebo groups.
次要结局
- Difference in mean changes in HbA1c, cholesterol, LDL, HDL, body weight and/or BMI, waist circumference, 2 hr oral glucose tolerance test.(Baseline and Week 12)