NCT04767789已完成不适用
Double-blind, Placebo-controlled, Randomized Pilot Clinical Trial to Evaluate the Efficacy and Safety of the Probiotic Strains Limosilactocillus Reuteri DSM 32910 and Lacticaseibacillus Paracasei DSM 32851 on Glucose Homeostatis in Prediabetic Adults
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 13
- 主要终点
- Glycated Hemoglobin A1c (HbA1c)
研究概览
简要总结
The aim of this international, randomized, parallel arms, double-blind, placebo-controlled clinical trial is to investigate the safety and efficacy of a combination of the two Lactobacillus strains (NZ-GHMH-01) on glucose and insulin metabolism, in prediabetic subjects. This trial will include prediabetic (insulin resistant) subjects with excessive body weight (over-weight or obese, showing abdominal or visceral obesity) to be able to investigate the effect of the probiotic NZ-GHMH-01 on glycaemic control.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Aged between 18 and 75 years (limits included)
- •Having BMI between 18,5 and 40 kg/m² (limits included)
- •Prediabetic
- •For women: Non menopausal with the same reliable contraception or menopausal without or with hormone replacement therapy
- •Agreeing to keep his lifestyle habits unchanged throughout the study
- •With stable weight within ± 5% in the last three months
- •Having a good general and mental health with in the opinion of the investigator
- •Having signed informed consent form
- •Affiliated with a social security scheme (for French sites only)
- •Agreed to be registered on the subjects in the "VRB" (biomedical research file (for French sites only))
- •Having HbA1c level ≥ 5.7% and ≤ 6.4%
排除标准
- •Metabolic disorder such as diabetes or uncontrolled thyroidal trouble or other metabolic disorder;
- •Having a history of medication for diabetes and dyslipidemia
- •Uncontrolled hypertension
- •Severe chronic disease or gastrointestinal disorders
- •Having done the second injection of COVID-19 vaccination or between the first and the second injection within the last 2 weeks prior to V1 visit
- •Food allergy or intolerance or hypersensitivity to any of the study products' ingredient
- •Pregnant or lactating women or intending to become pregnant within 3 months ahead
- •Smoking subject (more than 5 cigarettes per day)
- •Having a history of bariatric surgery
- •Having a history of any surgery in the 3 months before V1 visit or having scheduled any surgery within 6 months ahead
- •Under dietary supplement except fibers, omega 3 and vitamins (other than Vitamin D3) if the subject agrees to keep his/her intake unchanged throughout the study;
- •Under treatment which could significantly affect parameter(s) followed during the study
- •Under antibiotic treatment in the 3 to 6 months before V1 visit
- •With 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
- •With a current or planned in the next 5 months specific diet (hyper or hypocaloric, vegan...) or putted in place since less than 3 months before the inclusion visit
- •With a personal history of anorexia nervosa, bulimia or significant eating disorders according to the investigator
- •Abuse of alcohol, defined as more than 21 alcohol units per week for men and 14 units for women, or unwillingness to refrain from alcohol intake the day before V2 and V5 visits
- •Having a lifestyle deemed incompatible with the study according to the investigator
- •Taking part in another clinical trial or having taken part in another clinical trial in the 3 months before the inclusion visit;
- •Having received, during the last 12 months, indemnities for clinical trial higher or equal to 4500 Euros (for French sites only);
- •Under legal protection (guardianship, wardship) or deprived from his rights following administrative or judicial decision;
- •Presenting a psychological or linguistic incapability to sign the informed consent;
- •Impossible to contact in case of emergency.
- •Having blood ASAT, ALAT or GGT levels out of range and clinically significant according to the investigator
- •Having CBC with hemoglobin < 11 g/L or leucocytes < 3000 /mm3 or leucocytes > 16000 /mm3 or clinically significant abnormality according to the investigator
结局指标
主要结局
Glycated Hemoglobin A1c (HbA1c)
时间窗: V2 (randomization) and V5 (16 weeks of intervention)
Change from Baseline of HbA1c level between V2 and V5 visits (in %) between both groups.
次要结局
- Glucose kinetic parameters: ΔPeak and Cmax(V2 (randomization) and V5 (16 weeks of intervention))
- Glucose kinetic parameters: T max(V2 (randomization) and V5 (16 weeks of intervention))
- Incremental Area Under the Curve (iAUC) of glucose(V2 (randomization) and V5 (16 weeks of intervention))
- Incremental Area Under the Curve (iAUC) of insulinemia(V2 (randomization) and V5 (16 weeks of intervention))
- Homeostasis Model of Assessment - insulin resistance (HOMA-IR)(V2 (randomization), V3 (4 weeks of intervention), V4 (12 weeks of intervention) and V5 (16 weeks of intervention))
- Glycated Hemoglobin A1c (HbA1c)(V3 (4 weeks of intervention), V4 (12 weeks of intervention) and V5 (16 weeks of intervention))
- Quantitative Insulin sensitivity Check Index (QUICKI)(V2 (randomization), V3 (4 weeks of intervention), V4 (12 weeks of intervention) and V5 (16 weeks of intervention))
- Glycemia(V2 (randomization) and V5 (16 weeks of intervention))
- Insulin Sensitivity Index (ISI)(V2 (randomization), V3 (4 weeks of intervention), V4 (12 weeks of intervention) and V5 (16 weeks of intervention))
- Fasting Plasma Glucose (FPG)(V2 (randomization), V3 (4 weeks of intervention), V4 (12 weeks of intervention) and V5 (16 weeks of intervention))
- Fasting insulinemia(V2 (randomization), V3 (4 weeks of intervention), V4 (12 weeks of intervention) and V5 (16 weeks of intervention))
- Glucagon Like Peptide 1 (GLP-1)(V2 (randomization) and V5 (16 weeks of intervention))
- Weight(V2 (randomization), V3 (4 weeks of intervention), V4 (12 weeks of intervention) and V5 (16 weeks of intervention))
- Body Mass Index (BMI)(V2 (randomization), V3 (4 weeks of intervention), V4 (12 weeks of intervention) and V5 (16 weeks of intervention))
- Waist and Hip(V2 (randomization), V3 (4 weeks of intervention), V4 (12 weeks of intervention) and V5 (16 weeks of intervention))
- Liver function(V2 (randomization), V3 (4 weeks of intervention), V4 (12 weeks of intervention) and V5 (16 weeks of intervention))
- Total bilirubin(V1 (screening) and V5 (16 weeks of intervention))
- Triglycerides(V2 (randomization), V3 (4 weeks of intervention), V4 (12 weeks of intervention) and V5 (16 weeks of intervention))
- Anthropometric ratios(V2 (randomization), V3 (4 weeks of intervention), V4 (12 weeks of intervention) and V5 (16 weeks of intervention))
- Lipid homeostasis(V2 (randomization), V3 (4 weeks of intervention), V4 (12 weeks of intervention) and V5 (16 weeks of intervention))
- Cytokines(V2 (randomization), V3 (4 weeks of intervention), V4 (12 weeks of intervention) and V5 (16 weeks of intervention))
- Tumor Necrosis Factors alpha (TNFα)(V2 (randomization), V3 (4 weeks of intervention), V4 (12 weeks of intervention) and V5 (16 weeks of intervention))
- Blood metabolites(V2 (randomization) and V5 (16 weeks of intervention))
- high-sensitivity C-reactive Protein (CRPhs)(V2 (randomization), V3 (4 weeks of intervention), V4 (12 weeks of intervention) and V5 (16 weeks of intervention))
- Overall health(V2 (randomization), V3 (4 weeks of intervention), V4 (12 weeks of intervention) and V5 (16 weeks of intervention))
- Gastrointestinal Symptoms(V2 (randomization), V3 (4 weeks of intervention), V4 (12 weeks of intervention) and V5 (16 weeks of intervention))
研究者
研究点 (13)
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