NCT04767672进行中（未招募）不适用
Randomized, Double-Blinded, Placebo-Controlled Study to Assess the Effects of Short-Chain Fructo-Oligosaccharides on Long-Term Glucose Homeostasis in Untreated Prediabetic Subjects
Tereos4 个研究点 分布在 1 个国家目标入组 66 人开始时间: 2021年5月5日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 66
- 试验地点
- 4
- 主要终点
- Glycated hemoglobin
研究概览
简要总结
This clinical study aims to prove that the efficacy of non digestible carbohydrates supplementation (daily dose of 20 grams consumed twice a day for 12 weeks) on the regulation of glucose homeostasis is superior than placebo in prediabetic subjects.
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age between 18 and 65 years (limits included);
- •BMI between 23 and 34.9 kg/m² (limits included);
- •Dysglycemic or prediabetic subjects with no antidiabetic medication (medical or lifestyle (hygiene-dietetic measures or specific regimen treatment);
- •Consuming 10 to 20 g quantity of fiber per day (based on the 3-days food diary fulfilled by the subject between V1 and V2 visits);
- •Smoking maximum 10 cigarettes per week or equivalent and agreeing to keep this habit unchanged throughout the study;
- •Able and willing to participate to the study by complying with the protocol procedures as evidenced by his dated and signed informed consent form;
- •Affiliated with a social security scheme;
- •Agree to be registered on the volunteers in biomedical research file;
- •Fasting venous glycemia ≥ 1 g/L and ≤ 1.25 g/L at V1 visit.
排除标准
- •Metabolic disorder such as diabetes, uncontrolled thyroidal trouble or other metabolic disorder;
- •Severe chronic disease or Intestinal Bowel Syndrome (IBS) or gastrointestinal disorders found to be inconsistent with the conduct of the study by the investigator;
- •History of retinopathy, microalbuminuria, ischemic cardiovascular event in the 6 months before the study;
- •Known or a suspected food allergy or intolerance orhypersensitivity to any food ingredient;
- •Known or suspected food allergy or intolerance or hypersensitivity to any of the study products' ingredient;
- •Pregnant or lactating women or intending to become pregnant within 4 months ahead;
- •Women starting hormone replacement therapy or oral contraception (treatment must be stable for at least 3 months);
- •History of bariatric surgery;
- •History of any surgery in the 3 months before V1 visit or having scheduled any surgery within 4 months ahead;
- •Under dietary supplement which could significantly affect parameter(s) followed during the study according to the investigator or stopped in a too short period before the V1 visit (< 3 months);
- •Under treatment which could significantly affect parameter(s) followed during the study according to the investigator or stopped less than 3 months before the V1 visit;
- •Under antibiotic treatment in the 3 to 6 months before V1 visit, depending on the antibiotic consumed and according to the investigator;
- •Significant change in food habits or in physical activity in the 3 months before V1 visit or not agreeing to keep them unchanged throughout the study;
- •Current or planned in the next 4 months specific diet (hyper or hypocaloric, vegan, vegetarian...) or stopped less than 3 months before the study;
- •Personal history of anorexia nervosa, bulimia or significant eatingdisorders according to the investigator;
- •Consuming more than 3 standard drinks of alcoholic beverage daily for men or 2 daily for women or not agreeing to keep his alcohol consumption habits unchanged throughout the study;
- •Taking part in another clinical trial or being in the exclusion period of a previous clinical trial;
- •Having received, during the last 12 months, indemnities for clinical trial higher or equal to 4500 Euros;
- •Under legal protection (guardianship, wardship) or deprived from his rights following administrative or judicial decision;
- •Psychological or linguistic incapability to sign the informed consent;
- •Impossible to contact in case of emergency.
- •Fasting blood triglycerides > 3,5 g/L;
- •Fasting blood of total cholesterol > 4,5 g/L or HDLc < 0,1 g/L with an abnormality judged as clinically significant according to the investigator;
- •Blood ASAT, ALAT or GGT > 3 times ULN (laboratory Upper Limit of Normal);
- •Blood urea > 12 mmol/L or creatinine > 125 μmol/L;
- •Complete Blood Count (CBC) with hemoglobin < 11 g/L or leucocytes < 3000/mm3 or leucocytes > 16000/mm3.
结局指标
主要结局
Glycated hemoglobin
时间窗: V2 (randomization) and V5 (12 weeks of intervention)
Change from baseline of Hba1c level (%)
次要结局
- Incremental Area Under the Curve (iAUC) of glycemia(V2 (randomization) and V5 (12 weeks of intervention))
- Bone mineral composition(V2 (randomization) and V5 (12 weeks of intervention))
- Total Body Mass(V2 (randomization) and V5 (12 weeks of intervention))
- Waist and Hip measurement(V2 (randomization), V3 (4 weeks of intervention), V4 (8 weeks of intervention) and V5 (12 weeks of intervention))
- Anthropometric ratios(V2 (randomization), V3 (4 weeks of intervention), V4 (8 weeks of intervention) and V5 (12 weeks of intervention))
- Fructosamine(V2 (randomization), V3 (4 weeks of intervention), V4 (8 weeks of intervention) and V5 (12 weeks of intervention))
- Glycemia level(V2 (randomization) and V5 (12 weeks of intervention))
- Glucacon-like Peptide 1 (GLP-1)(V2 (randomization) and V5 (12 weeks of intervention))
- Total lean mass(V2 (randomization) and V5 (12 weeks of intervention))
- Body Mass Index (BMI)(V2 (randomization), V3 (4 weeks of intervention), V4 (8 weeks of intervention) and V5 (12 weeks of intervention))
- Satiety and Appetite sensation(V2 (randomization) and V5 (12 weeks of intervention))
- Glycated hemoglobin(V2 (randomization), V3 (4 weeks of intervention), V4 (8 weeks of intervention) and V5 (12 weeks of intervention))
- Fasting glycemia(V2 (randomization), V3 (4 weeks of intervention), V4 (8 weeks of intervention) and V5 (12 weeks of intervention))
- Fasting insulinemia(V2 (randomization), V3 (4 weeks of intervention), V4 (8 weeks of intervention) and V5 (12 weeks of intervention))
- Insulin indexes(V2 (randomization), V3 (4 weeks of intervention), V4 (8 weeks of intervention) and V5 (12 weeks of intervention))
- Insulin sensitivity index(V2 (randomization) and V5 (12 weeks of intervention))
- Insulinemia(V2 (randomization) and V5 (12 weeks of intervention))
- Incremental Area Under the Curve (iAUC) of insulinemia(V2 (randomization) and V5 (12 weeks of intervention))
- Total fat mass(V2 (randomization) and V5 (12 weeks of intervention))
- Bone Mineral Density(V2 (randomization) and V5 (12 weeks of intervention))
- Weight(V2 (randomization), V3 (4 weeks of intervention), V4 (8 weeks of intervention) and V5 (12 weeks of intervention))
- Total energy intake(V2 (randomization), V3 (4 weeks of intervention), V4 (8 weeks of intervention) and V5 (12 weeks of intervention))
- Fecal Short-Chain Fatty Acids (SCFA)(V2 (randomization) and V5 (12 weeks of intervention))
- Energy intake(V2 (randomization), V3 (4 weeks of intervention), V4 (8 weeks of intervention) and V5 (12 weeks of intervention))
- Intestinal microbiota composition(V2 (randomization) and V5 (12 weeks of intervention))
- Fiber intake(V2 (randomization), V3 (4 weeks of intervention), V4 (8 weeks of intervention) and V5 (12 weeks of intervention))
- Alcohol intake(V2 (randomization), V3 (4 weeks of intervention), V4 (8 weeks of intervention) and V5 (12 weeks of intervention))
- Biomarker of inflammation(V2 (randomization), V3 (4 weeks of intervention), V4 (8 weeks of intervention) and V5 (12 weeks of intervention))
研究者
Isabelle Metreau
Coordinating investigator
Tereos
研究点 (4)
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