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临床试验/NCT07408479
NCT07408479招募中不适用

Impact of Starch Digestibility on Glycemic Variability and Control, Cardiometabolic and Inflammatory Profiles, Microbiota and Intestinal Health in Subjects With Insulin Resistance

Mondelēz International, Inc.1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2025年11月15日最近更新:
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适应症
干预措施

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
40
试验地点
1
主要终点
Change in MAGE measured on 3 occasions between diets High or Low in SDS and RS
研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

To study the potential impact of a diet rich in both Slowly Digestible Starch (SDS) and Resistant Starch (RS), we propose a 2-month nutritional intervention study in which we will study the evolution of carbohydrate variability and metabolism and health-related parameters in 40 volunteers with insulin resistance. Regular sampling of blood, urine and faeces as well as continuous measurement of blood glucose levels will be performed to assess changes in blood glucose levels, insulin resistance, lipid metabolism, inflammation and the composition of the microbiota following the introduction of starch products rich in SDS and RS into the diet.

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
Double (Participant, Outcomes Assessor)

盲法说明

Each diet will be labelled "Diet A" or "Diet B" with both diets containing similar categories of products

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

  • •General criteria:
  • •Age between 18 and 75 years (bounds included)
  • •HOMA-IR ≥ 2.5
  • •Body Mass Index (BMI) between 25 and 40 kg/m² (bounds included)
  • •Stable weight over the past 3 months (+/- 5% of body weight)
  • •Waist circumference > 80 cm for women, > 94 cm for men
  • •Sedentary subject or subject practising regular and stable physical activity for the duration of the study (maximum 4 hours per week)
  • •Able to understand the provided information and having signed the informed consent forms
  • •Able to read and write in French
  • •Having a freezer and comfortable with storing stool samples at home
  • •Having undergone a prior medical examination during the screening visit
  • •Food-related criteria:
  • •Willing to modify their diet for 2 months
  • •No food intolerances or allergies
  • •Regular consumption of the study products
  • •Fiber intake ≤ 25 g/day
  • •Willing to consume three main meals with no more than one snack per day and to take meals or snacks at least two hours apart

排除标准

  • •General criteria:
  • •Adult under legal protection (guardianship or curatorship)
  • •Person with unstable medical or psychological conditions that, according to the investigator, could lead to non-compliance or non-cooperation during the study or compromise safety or participation (as per Articles L.1121-6, L.1121-8, L.1121-9, and L.1122-1-2 of the French Public Health Code)
  • •Presence of a condition identified during clinical examination or medical interview that could interfere with study evaluations, as judged by the investigator
  • •Person deprived of liberty by judicial or administrative decision
  • •Failure to comply with the exclusion period of another study as indicated in the "national volunteer database"
  • •Person exceeding the annual compensation limit for participation in research protocols
  • •Tobacco (or vaping equivalent) consumption > 5 cigarettes per day and inability to abstain from smoking or vaping from the evening prior to exploration days specified in the protocol
  • •Alcoholism or alcohol abuse (> 30 g/day). Consuming more than three alcoholic drinks per day is considered abusive. One alcoholic drink corresponds to 30 mL of spirits, 120 mL of wine, or 330 mL of beer or abuse or dependency on another drug
  • •Person not affiliated with a social security system or benefiting from a similar scheme
  • •Absence of valid, approved health certificates in the event of government measures during an exceptional epidemic situation
  • •Biological criteria:
  • •Fasting blood glucose ≥ 7 mmol/L or ≥ 1.26 g/L
  • •Triglycerides > 4 g/L
  • •LDL-cholesterol > 1.90 g/L
  • •eGRF (estimated glomerular filtration rate) < 60 ml/min
  • •Other biological abnormality with significant clinical relevance according to the investigator
  • •Population-related criteria :
  • •Person with a specific dietary regimen (vegetarian, lacto-vegetarian, vegan, high-protein, low-carbohydrates, weight-loss diet, etc.)
  • •Person consuming dietary supplements (prebiotics, probiotics, or minerals such as divalent cations like magnesium and calcium) regularly in the month before the selection visit and during the study
  • •Blood donation within 2 months prior to the selection visit
  • •Claustrophobia preventing indirect calorimetry measurement
  • •Limited venous access making blood sampling and catheter placement difficult
  • •Therapeutic and medical criteria:
  • •Type 1 or Type 2 diabetes
  • •Systolic blood pressure ≥ 140 mmHg
  • •Diastolic blood pressure ≥ 90 mmHg
  • •Hypertension treatment
  • •Known endocrine pathology interfering with carbohydrate metabolism (uncontrolled thyroid dysfunction, acromegaly, hypercortisolism, etc.)
  • •Gastrointestinal diseases with an inflammatory component or associated with malabsorption or considered likely to interfere with the results of the study;
  • •History of bloody diarrhea
  • •Exocrine pancreatic insufficiency
  • •History of bariatric surgery
  • •History of digestive surgery, except appendectomy and simple hernia repair
  • •Severe eating disorders (e.g., anorexia, bulimia, binge-eating disorder, night-eating syndrome) as judged by the investigator;
  • •Hepatocellular insufficiency
  • •Immunosuppressed individuals (e.g., those with AIDS, lymphoma, long-term corticosteroid therapy, chemotherapy, or allogeneic transplant)
  • •Central venous catheter carriers and post-surgical patients
  • •Any other clinically significant unstable or untreated abnormality in the immunological, neoplastic, endocrine, hematological, gastrointestinal, hepatic, neurological, or psychiatric domains, as judged by the investigator
  • •Obesity medication use within the past 3 months or during the study
  • •Antibiotic use in the month prior to explorations (for common beta-lactam antibiotics) or within 3 months before explorations (for other antibiotics), as judged by the investigator
  • •Daily laxative use within the 3 months prior to explorations or other medications significantly interfering with gut microbiota composition;
  • •Use of treatments that could interfere with study measurements, as judged by the study's co-investigating physicians
  • •Pregnant, planning to become pregnant (verified by a blood pregnancy test), or breastfeeding woman
  • •Person with known allergy to adhesive materials

研究组 & 干预措施

High SDS-RS diet

Active Comparator

Balanced diet containing high levels of Slowly digestible Starch (SDS) and Resistant Starch (RS)

干预措施: Balanced diet high in Slowly Digestible Starch and Resistant Starch (Other)

Low SDS-RS diet

Placebo Comparator

Balanced diet containing low levels of Slowly digestible Starch (SDS) and Resistant Starch (RS)

干预措施: Balanced diet low in Slowly Digestible Starch and Resistant Starch (Other)

结局指标

主要结局

Change in MAGE measured on 3 occasions between diets High or Low in SDS and RS

时间窗: Evaluations done before, after 1 week and after 2 months on a diet

Mean Amplitude of Glucose Excursions (MAGE) from CGMS record

次要结局

  • Glycemia iAUC after a standard challenge test (FlexMeal) during the first metabolic day(5 hours post standard challenge test during visit 2 (before starting nutritional intervention))
  • Insulin iAUC after a standard challenge test (FlexMeal) during the first metabolic day(5 hours post standard challenge test during visit 2 (before starting nutritional intervention))
  • GLP-1 iAUC after a standard challenge test (FlexMeal) during the first metabolic day(5 hours post standard challenge test during visit 2 (before starting nutritional intervention))
  • Inflammatory status comparison during the first metabolic day : CRP concentration(At baseline during V2 (before starting nutritional intervention))
  • Inflammatory impacts after a standard challenge test (FlexMeal) during the first metabolic day (V2) : TNFa iAUC(5 hours post challenge test during visit 2 (before starting nutritional intervention))
  • Inflammatory impacts after a standard challenge test (FlexMeal) during the first metabolic day (V2) : IL6 iAUC(5 hours post challenge test during visit 2(before starting nutritional intervention))
  • Inflammatory impacts after a standard challenge test (FlexMeal) during the first metabolic day (V2) : IL1Ra iAUC(5 hours post challenge test during visit 2 (before starting nutritional intervention))
  • Inflammatory impacts after a standard challenge test (FlexMeal) during the first metabolic day : IL18 iAUC(5 hours post challenge test during visit 2 (before starting nutritional intervention))
  • Glycemic impacts comparison following the intake of a diet either high or low in SDS and RS(In fasting state during visits V2, V4 and V6 (before and after 4 and 8 weeks of nutritional intervention))
  • Insulinemic impacts comparison following the intake of a diet either high or low in SDS during the time course of the study(In fasting state during visits V2, V4 and V6 (before and after 4 and 8 weeks of nutritional intervention))
  • Inflammatory impacts comparison following the intake of a diet either high or low in SDS during the time course of the study : CRPus concentration(In fasting state during visits V2, V4 and V6 (before and after 4 and 8 weeks of nutritional intervention))
  • Inflammatory impacts comparison following the intake of a diet either high or low in SDS during the time course of the study : TNFa concentration(In fasting state during visits V2, V4 and V6 (before and after 4 and 8 weeks of nutritional intervention))
  • Inflammatory impacts comparison following the intake of a diet either high or low in SDS during the time course of the study : IL6 concentration(In fasting state during visits V2, V4 and V6 (before and after 4 and 8 weeks of nutritional intervention))
  • Inflammatory impacts comparison following the intake of a diet either high or low in SDS during the time course of the study : IL1Ra concentration(In fasting state during visits V2, V4 and V6 (before and after 4 and 8 weeks of nutritional intervention))
  • Inflammatory impacts comparison following the intake of a diet either high or low in SDS during the time course of the study : IL18 concentration(In fasting state during visits V2, V4 and V6 (before and after 4 and 8 weeks of nutritional intervention))
  • Oxidative Stress comparison following the intake of a diet either high or low in SDS during the time course of the study : MDA concentration(In fasting state during visits V2, V4 and V6 (before and after 4 and 8 weeks of nutritional intervention))
  • Oxidative Stress comparison following the intake of a diet either high or low in SDS during the time course of the study : Urinary isoprostanes concentration(In fasting state during visits V2, V4 and V6 (before and after 4 and 8 weeks of nutritional intervention))
  • Cardiovascular risk markers comparison following the intake of a diet either high or low in SDS during the time course of the study : sICAM concentration(In fasting state during visits V2, V4 and V6 (before and after 4 and 8 weeks of nutritional intervention))
  • Cardiovascular risk markers comparison following the intake of a diet either high or low in SDS during the time course of the study : sVCAM concentration(In fasting state during visits V2, V4 and V6 (before and after 4 and 8 weeks of nutritional intervention))
  • Glycemic impacts characterisation of a standard challenge test (FlexMeal) during the second metabolic day(5 hours post standard challenge test during visit 6 (after 8 weeks of nutritional intervention))
  • Insulinemic impacts characterisation of a standard challenge test (FlexMeal) during the second metabolic day(5 hours post standard challenge test during visit 6 (after 8 weeks of nutritional intervention))
  • GLP1 iAUC characterisation of a standard challenge test (FlexMeal) during the second metabolic day(5 hours post standard challenge test during visit 6 (after 8 weeks of nutritional intervention))
  • Inflammatory impacts comparison following 2 months of intake of a diet either high or low in SDS : CRPus concentration(In fasting state during visit 6 (after 8 weeks of nutritional intervention))
  • Inflammatory impacts characterisation of a standard challenge test (FlexMeal) during the second metabolic day : TNFa iAUC(5 hours post standard challenge test during visit 6 (after 8 weeks of nutritional intervention))
  • Inflammatory impacts characterisation of a standard challenge test (FlexMeal) during the second metabolic day : IL6 iAUC(5 hours post standard challenge test during visit 6 (after 8 weeks of nutritional intervention))
  • Inflammatory impacts characterisation of a standard challenge test (FlexMeal) during the second metabolic day : IL1Ra iAUC(5 hours post standard challenge test during visit 6 (after 8 weeks of nutritional intervention))
  • Inflammatory impacts characterisation of a standard challenge test (FlexMeal) during the second metabolic day : IL18 iAUC(5 hours post standard challenge test during visit 6 (after 8 weeks of nutritional intervention))
  • Glycemic profile parameters following the intake of a diet either high or low in SDS during the time course of the study : MAGE(minimum 3 days to a maximum of 6 days of CGMS record starting at Visit 1, Visit 3 and Visit 5 (before, after 3 and 7 weeks of nutritional intervention))
  • Glycemic profile parameters following the 3 months consumption of a diet either high or low in SDS : TIR(minimum 3 days to a maximum of 6 days of CGMS record starting at visit 1, Visit 3 or visit 5 (before, after 3 and 7 weeks of nutritional intervention))
  • Glycemic profile parameters following the intake of a diet either high or low in SDS during the time course of the study : CV(minimum 3 days to a maximum of 6 days of CGMS record starting at visit 1, visit 3 and visit 5 (before, after 3 and 7 weeks of nutritional intervention))
  • Glycemic profile parameters following the intake of a diet either high or low in SDS during the time course of the study : SD(minimum 3 days to a maximum of 6 days of CGMS record starting at visit 1, visit 3 and visit 5 (before, after 3 and 7 weeks of nutritional intervention))
  • Glycemic profile parameters following the intake of a diet either high or low in SDS during the time course of the study : MIME(minimum 3 days to a maximum of 6 days of CGMS record starting at visit 1, visit 3 and visit 5 (before, after 3 and 7 weeks of nutritional intervention))
  • Glycemic profile parameters following the intake of a diet either high or low in SDS during the time course of the study : MODD(minimum 3 days to a maximum of 6 days of CGMS record starting at visit 1, visit 3 and visit 5 (before, after 3 and 7 weeks of nutritional intervention))
  • Glycemic profile parameters following the intake of a diet either high or low in SDS during the time course of the study : CONGA(minimum 3 days to a maximum of 6 days of CGMS record starting at visit 1, visit 3 and visit 5 (before, after 3 and 7 weeks of nutritional intervention))
  • Glycemic profile parameters following the intake of a diet either high or low in SDS during the time course of the study : ADRR(minimum 3 days to a maximum of 6 days of CGMS record starting at visit 1, visit 3 and visit 5 (before, after 3 and 7 weeks of nutritional intervention))
  • Glycemic profile parameters following the intake of a diet either high or low in SDS during the time course of the study : LGBI(minimum 3 days to a maximum of 6 days of CGMS record starting at visit 1, visit 3 and visit 5 (before, after 3 and 7 weeks of nutritional intervention))
  • Glycemic profile parameters following the intake of a diet either high or low in SDS during the time course of the study : HGBI(minimum 3 days to a maximum of 6 days of CGMS record starting at visit 1, visit 3 and visit 5 (before, after 3 and 7 weeks of nutritional intervention))
  • Mean daylong incremental Area Under the Curve (iAUC) of glycemia, measured by CGMS, following the intake of a diet either high or low in SDS during the time course of the study(from 0 minutes to 360 minutes postprandial during the CGMS record periods starting on visit 1, visit 3 and visit 5 (before, after 3 and 7 weeks of nutritional intervention))
  • Mean daylong total Area Under the Curve (tAUC) of glycemia, measured by CGMS, following the intake of a diet either high or low in SDS during the time course of the study(from 0 minutes to 360 minutes postprandial during the CGMS record periods starting on visit 1, visit 3 and visit 5 (before, after 3 and 7 weeks of nutritional intervention))
  • Diabetes follow-up markers : HbA1c(In fasting state, during visit 2, visit 4 and visit 6 (before and after 4 and 8 weeks of nutritional intervention))
  • Diabetes follow-up markers : Fructosamine concentration(In fasting state, during visit 2, visit 4 and visit 6 (before and after 4 and 8 weeks of nutritional intervention))
  • Diabetes follow-up markers : Glycated Albumin concentration(In fasting state, during visit 2, visit 4 and visit 6 (before and after 4 and 8 weeks of nutritional intervention))
  • Anthropometry parameters(In fasting state, during visit 2, visit 4 and visit 6 (before and after 4 and 8 weeks of nutritional intervention))
  • Antropometry parameters : body weight(In fasting state, during visit 2, visit 4 and visit 6 (before and after 4 and 8 weeks of nutritional intervention))
  • Anthropometric parameters : waist circumference(In fasting state, during visit 2, visit 4 and visit 6 (before and after 4 and 8 weeks of nutritional intervention))
  • Athropometric parameters : hip circumference(In fasting state, during visit 2, visit 4 and visit 6 (before and after 4 and 8 weeks of nutritional intervention))
  • Body composition parameters characterisation : total body water(In fasting state, during visit 2 and visit 6 (before and after 8 weeks of nutritional intervention))
  • Body composition parameters characterisation : body fat(In fasting state, during visit 2 and visit 6 (before and after 8 weeks of nutritional intervention))
  • Body composition parameters characterisation : lean mass(In fasting state, during visit 2 and visit 6 (before and after 8 weeks of nutritional intervention))
  • Resting energy metabolism profile : Resting Metabolism Rate(In fasting state, during visit 2 and visit 6 (before and after 8 weeks of nutritional intervention))
  • Exhaled gases - Dihydrogen(Measured at time 0, 60, 120, 180, 240 minutes of breath test during visit 1 and visit 5 ((before and after 7 weeks of nutritional intervention))
  • Exhaled gases - Methane(Measured at time 0, 60, 120, 180, 240 minutes of breath test during visit 1 and visit 5 (before and after 7 weeks of nutritional intervention))
  • Exhaled gases : Volatile Organic Compounds(Measured at time T-30 minutes of breath test during visit 2 and visit 6 (before and after 8 weeks of nutritional intervention))
  • Gut microbiota composition(Measured on samples collected at visit 2, visit 4 and visit 6 (before and after 4 and 8 weeks of nutritional intervention))
  • Microbiota activity : short chain fatty acids(Measured on samples collected at visit 2, visit 4 and visit 6 (before and after 4 and 8 weeks of nutritional intervention))
  • Microbiota functionlity(Measured on samples collected at visit 2, visit 4 and visit 6 (before and after 4 and 8 weeks of nutritional intervention))
  • Level of physical activity characterisation following the intake of a diet either high or low in SDS during the time course of the study : IPAQ(Evaluated at the arrival in the laboratory during visit 2, visit 4 and visit 6 (before and after 4 and 8 weeks of nutritional intervention))

研究者

发起方
Mondelēz International, Inc.
申办方类型
Industry
责任方
Sponsor

研究点 (1)

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