Targeted Precision Nutrition Strategy To Prevent Chronic Metabolic Diseases
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 240
- 试验地点
- 2
- 主要终点
- Matsuda Index
研究概览
简要总结
Nutrition is very important to keep blood sugar levels balanced. If blood sugar levels are too high, it can lead to diseases such as cardiovascular disease and type 2 diabetes (T2DM). Therefore, adjusting what one eats, also called a diet or nutritional intervention, can help prevent these diseases. However, not everyone responds the same to a diet. In about 30% of people, a diet does not work as hoped. This can be due to various reasons, such as a person's metabolism, genetic predisposition, the composition of the food one eats, or the bacteria in the intestines. Everyday things like sleep, stress, and movement also play a role. The investigators used a computer model to classify people with overweight and obesity into groups based on these factors. The investigators call such a group a 'Metabolic Phenotype', or in short 'Metabotype'. Based on the Metabotype, a personalised diet was developed (personalised nutrition intervention) that may better suit each person's unique situation.
The investigators hypothesize that a precision nutrition intervention, tailored to Metabotypes identified through unsupervised clustering (using the aforementioned computer model) of predefined, accurate features related to cardiometabolic health-specifically, tissue-specific glucose and lipid metabolism and detailed body composition-will enhance blood glucose homeostasis, reduce cardiometabolic risk, and improve adherence to the intervention and mental well-being, compared to population-based dietary guidelines. The present project will contribute to targeted and efficient precision-based dietary strategies for individuals at increased risk of T2DM.
详细描述
Objective:
Our study aims to identify unique Metabotypes among individuals with overweight and obesity and assess their response to a 1-year precision dietary macronutrient modulation. The objective is to provide proof-of-concept that this approach improves glucose homeostasis, dietary adherence, and psychosocial well-being compared to population-based dietary guidelines.
Study design:
Two-centre dietary intervention study with a double-blind, randomised controlled parallel design, based on participants' Metabotype and hypothesized optimal diet. Participants' Metabotype and intervention arm will be blinded to the participants and researchers. Metabotypes were identified through hierarchical clustering of Principal Components (HCPC) using baseline data from The Maastricht Study (participant demographics, body composition, glucose- and insulin metabolism), whereafter clusters were cross-validated in independent cohorts. Based on a combination of post-hoc analyses of dietary intervention trials and literature, the optimal dietary macronutrient composition was determined for these Metabotypes.
Study population:
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, Investigator)
入排标准
- 年龄范围
- 40 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Men and women with a BMI ≥25 to <40 kg/m2
- •Classification possible to one of the investigational metabolic phenotypes according to the classification algorithm.
- •Weight stability for at least 3 months (+/- 3 kg)
排除标准
- •(Pre-)diagnosis of type 1 or type 2 diabetes mellitus (i.e., FPG ≥ 7,0 mmol/L) and HbA1c ≥ 6,5% (48 mmol/mol)
- •Renal or hepatic malfunctioning (pre-diagnosis or determined based on ALAT and creatinine values)
- •Gastrointestinal diseases or abdominal surgery (allowed i.e.:
- •appendectomy, cholecystectomy)
- •Food allergies, intolerances (including gluten/lactose intolerance) and/or eating disorders interfering with the study
- •Cardiovascular diseases (e.g., heart failure) or cancer (e.g., noninvasive skin cancer allowed)
- •High systolic blood pressure (untreated >160/100 mmHg, drug-regulated >140/90 mmHg)
- •Diseases affecting glucose and/or lipid metabolism (e.g., pheochromocytoma, Cushing's syndrome, acromegaly)
- •Diseases with a life expectation shorter than 5 years
- •Major mental disorders
- •Drug treated thyroid diseases (well substituted hypothyroidism is allowed inclusion)
- •Other physical/mental conditions that may interfere with study outcomes
- •Medication known to interfere with study outcomes (e.g., PPAR-α or PPAR-γ agonists (fibrates), sulfonylureas, biguanides, α-glucosidaseinhibitors, thiazolidinediones, repaglinide, nateglinide, insulin, and chronic use of NSAIDs)
- •Use of certain anticoagulants other than acetylsalicylic acid
- •Use of antidepressants (stable use ≥ 3 months prior to and during study allowed)
- •Use of statins (stable use ≥ 3 months prior to and during study allowed)
- •Chronic corticosteroids treatment (>7 consecutive days of treatment)
- •Use of antibiotics within 3 months prior to the study
- •Participation in regular sports activities (moderate-to-vigorous physical exercise >4 hours per week)
- •Having a restricted dietary pattern interfering with the study diets (e.g., vegetarian, vegan, Atkins diet and/or other special diets)
- •Plans to lose or gain more than 5% body weight
- •Abuse of alcohol (alcohol consumption >14 units/week) and/or drugs (cannabis included)
- •Not willing to limit alcohol consumption to 7 drinks per week
- •Regular smoking (including use of e-cigarettes and vapes)
- •Use of strong vitamins or other dietary supplements (e.g., pre- or probiotics) expected to interfere with the study outcomes
- •Metabotype classification is not possible
- •Pregnant or lactating women, or women who are planning to become pregnant
- •Inability to comply with the study diet
- •Blood donation within the last 3 months
- •Participation in possibly interfering studies within the last 3 months
- •Inability to understand study information and/or communicate with staff
- •Unwillingness to be randomised or sign informed consent
- •Unwillingness to save data for 15 years
- •Deemed unsuitable for participation in the trial, for any reason, as judged by the research physician or principal investigator
研究组 & 干预措施
Precision Nutrition Group (PN)
For a total duration of 12 months, participants in the Precision Nutrition (PN) Group will follow a diet tailored to their Metabotype, which is hypothesised to be optimal for them.
干预措施: Optimal Metabotype-specific diet (Other)
Control Group (CN)
For a total duration of 12 months, participants in the Control Group (CN) will be randomly assigned one of the diets optimised for a different Metabotype of the same sex, which is hypothesised to be suboptimal for them.
干预措施: Sub-optimal diet (Other)
结局指标
主要结局
Matsuda Index
时间窗: Change from baseline at month 6 and month 12 following dietary intervention.
The primary objective of this study is to evaluate the effect of a 12-month Metabotype-targeted diet (PN) versus a non-targeted diet (CN) on whole-body insulin sensitivity (Matsuda Index; marker of whole-body fasting and postprandial insulin sensitivity). This will include within group post-hoc testing. The primary outcome measure will be assessed by means of a 7-point oral glucose tolerance test (OGTT), and calculated as follows: \[10,000 / square root of \[fasting plasma glucose (mg/dL) × fasting insulin (mU/L)\] × \[mean glucose (mg/dL) x mean insulin (mU/L)\]\].
次要结局
- Targeted plasma metabolomics(Baseline)
- Glucose tolerance(Change from baseline at month 6 and month 12 following dietary intervention.)
- Hip circumference(Change from baseline at month 6 and month 12 following dietary intervention.)
- Disposition Index (DI)(Change from baseline at month 6 and month 12 following dietary intervention.)
- HOMA-IR(Change from baseline at month 6 and month 12 following dietary intervention.)
- Muscle insulin sensitivity (MISI)(Change from baseline at month 6 and month 12 following dietary intervention.)
- Hepatic insulin resistance (HIRI)(Change from baseline at month 6 and month 12 following dietary intervention.)
- Adipose tissue insulin sensitivity (ATIRI)(Change from baseline at month 6 and month 12 following dietary intervention.)
- Insulinogenic Index (IGI)(Change from baseline at month 6 and month 12 following dietary intervention.)
- Glucose incremental area under the curve (iAUC)(Change from baseline at month 12 following dietary intervention.)
- HOMA-β(Change from baseline at month 6 and month 12 following dietary intervention.)
- Circulating hormones such as Insulin(Change from baseline at month 6 and month 12 following dietary intervention.)
- Body composition(Change from baseline at month 6 and month 12 following dietary intervention.)
- Waist circumference(Change from baseline at month 6 and month 12 following dietary intervention.)
- Waist-to-hip ratio (WHR)(Change from baseline at month 6 and month 12 following dietary intervention.)
- Subcutaneous adipose tissue gene expression(Change from baseline at month 6 and month 12 following dietary intervention.)
- Subcutaneous adipose tissue protein expression(Change from baseline at month 6 and month 12 following dietary intervention.)
- Blood pressure(Change from baseline at month 6 and month 12 following dietary intervention.)
- Mean 24h glucose concentrations(Change from baseline at month 12 following dietary intervention.)
- Physical activity(Change from baseline at month 12 following dietary intervention.)
- The frequency of hypo- and hyperglycemia(Change from baseline at month 12 following dietary intervention.)
- Mean Amplitude of Glucose Excursions (MAGE)(Change from baseline at month 12 following dietary intervention.)
- Time in Range (TIR)(Change from baseline at month 12 following dietary intervention.)
- Coefficient of Variation (CV%)(Change from baseline at month 12 following dietary intervention.)
- Standard Deviation (SD) of Glucose Levels(Time Frame: Change from baseline at month 12 following dietary intervention.)
- The duration of hypo- and hyperglycemia(Change from baseline at month 12 following dietary intervention.)
- Gut microbial composition(Change from baseline at month 12 following dietary intervention.)
- Circulating SCFA(Change from baseline at month 6 and month 12 following dietary intervention.)
- Circulating lipids such as FFA(Change from baseline at month 6 and month 12 following dietary intervention.)
- Circulating inflammatory markers such as CRP(Change from baseline at month 6 and month 12 following dietary intervention.)
- Circulating HbA1c(Change from baseline at month 6 and month 12 following dietary intervention.)
- Self-reported self-efficacy(Change from baseline at month 6 and 12 following dietary intervention.)
- Self-reported context-sensitive positive health(Change from baseline at month 1 and 12 following dietary intervention.)
- Self-reported mood(Change from baseline at month 6 and 12 following dietary intervention.)
- Self-reported stool consistency(Change from baseline at month 1 and 12 following dietary intervention.)
- Self-reported fatigue(Change from baseline at month 12 following dietary intervention.)
- Self-reported health-related quality of life(Change from baseline at month 1 and 12 following dietary intervention.)
- Self-reported positive health(Change from baseline at month 1 and 12 following dietary intervention.)
- Adherence to dietary recommendations(12-months, continuously throughout the study)
- Self-reported mental health(Change from baseline at month 6 and 12 following dietary intervention.)
- Self-reported perceived stress(Change from baseline at month 6 and 12 following dietary intervention.)
- Self-reported gastrointestinal health(Change from baseline at month 1 and 12 following dietary intervention.)
- Self-reported sleep quality(Change from baseline at month 12 following dietary intervention.)
- Self-reported chronotype(Change from baseline at month 12 following dietary intervention.)
- DNA analysis(Baseline)
- Self-reported daytime sleepiness(Change from baseline at month 12 following dietary intervention.)