To Evaluate the Intestinal Tolerance and Health Effects of Daily Consumption of Two Eggs With a Particular Fatty Acid Profile on a Set of Parameters Related to Metabolic Disorders
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 2
- 主要终点
- Glycated haemoglobin (HbA1c)
研究概览
简要总结
This study has two objectives: 1) to check that the daily consumption of two eggs with a particular fatty acid pattern rich in n-3 polyunsaturated fatty acids (α-linolenic acid, docosahexaenoic acid), conjugated-linoleic acid and conjugated-linolenic acid is well tolerated by the consumer ; 2) to evaluate the effects of the consumption of these eggs on health parameters in subjects presenting a risk of developing a metabolic disorder.
This monocentric study is an interventional, randomized, double-blind, control study.
详细描述
n-3 polyunsaturated fatty acids, conjugated-linoleic acids and conjugated-linolenic acids show interesting effects in the context of health. Indeed, some studies suggest positive effects on circulating lipids or inflammation associated with certain disorders such as diabetes, following the consumption of these fatty acids.
However, these fatty acids are not very present in the classic diet. Therefore, we have developped hens eggs naturally enriched in n-3 polyunsaturated fatty acids, conjugated-linoleic acids and conjugated-linolenic acids by changing the hens feed.
This study has two objectives: 1) to check that the daily consumption of two eggs with a particular fatty acid pattern rich in n-3 polyunsaturated fatty acids (α-linolenic acid, docosahexaenoic acid), conjugated-linoleic acid and conjugated-linolenic acid is well tolerated by the consumer ; 2) to evaluate the effects of the consumption of these eggs on health parameters in subjects presenting a risk of developing a metabolic disorder.
To do this, 80 subjects aged 35 to 75, sedentary (<2 hours of physical activity per week) and with abdominal obesity (> 94cm for men and> 80cm for women) were recruited and were divided into two groups: the control group (12 subjects consuming 2 classic eggs for 3 months per day) or the test group (12 subjects consuming 2 eggs enriched in omega per day for 3 months).
A medical examination with blood sampling was scheduled every month at baseline (Day 0), after one month (Day 30), after two months (Day 60) and at the end of the 3 months of intervention (Day90). During those visits, the following were monitored: glucose parameters, lipids parameters, fatty acid profile of red blood cells and plasma and safety parameters related to haematology, kidney and liver functions .
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
- 35 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Woman or man, aged of 35 to 75 years
- •Abdominal obesity : waist circumference for men > 94cm and > 80cm for women
- •Practicing < 2h of physical activity per week
排除标准
- •Uncontrolled systolic blood pressure > 160/100mmHg
- •For premenopausal women: pregnant or lactating women
- •For menopausal women: less than 6 months of menopause
- •Perimenopausal women with symptoms
- •Type II diabetes (fasted glycaemia ≥ 126mg/dl or HbA1c ≥ 6.5%), Type I diabetes
- •Medical history or actual cardiovascular disease (myocardial infarction, angina, transient ischemic attack, lower limb arteriopathy)
- •Familial history of premature cardiovascular incident (in male first degree relative < 55 years and in female first degree relative < 65 years; myocardial infarction, angina, transient ischemic attack, lower limb arteriopathy)
- •Medical history or actual liver, pancreas, kidney, pulmonary or gastrointestinal problem
- •Thyroid disorder
- •Cancer < 5 years before the screening visit
- •Smokers or who have stopped smoking within 6 months before the screening visit
- •Subject presenting allergy or food intolerance to eggs
- •Subjects with psychiatric problems and/or using antipsychotics
- •Drug addiction problem
- •Recent change of body weight > 5kg (< 3 months before the screening visit)
- •Within 3 months before the screening visit, change in the chronic (> 7 days in a row) intake or dosage of drug(s) or product(s) modifying
- •The glucose or lipid metabolism
- •The blood pressure and heart rate
- •Intestinal tolerance
- •Hepatic, pancreas or kidney functions
- •The inflammatory status
- •Current or recent (< 3 months before the screening visit) intake of dietary supplements rich in n-3 polyunsaturated fatty acid
- •Vegan diet
- •Consumption of fish > 3 times per week
- •Subjects who drink more than 3 glasses of alcohol per day (> 30 g of alcohol per day)
- •LDL > 159 mg/dl or total cholesterol > 239 mg/dl or triglyceride > 200 mg/dl or HDL < 40 mg/dl
- •Docosahexaenoic acid in red blood cell phospholipids > 8 %
- •Subjects having participated to another clinical trial < 1 month before the screening test visit
结局指标
主要结局
Glycated haemoglobin (HbA1c)
时间窗: Change from baseline (visit 1) glycated haemoglobin at 3 months (Day 90, visit 4)
Glycated haemoglobin (HbA1c) in blood samples
次要结局
- Reactive hyperemia index (LnRHI)(baseline (visit 1) and Day 90 (last visit 4))
- Sodium (Na)(baseline (visit 1), Day 30 (visit 2), Day 60 (visit 3) and Day 90 (last visit 4))
- 25-hydroxy-vitamin D(baseline (visit 1) and Day 90 (last visit 4))
- Glucose(baseline (visit 1), Day 30 (visit 2), Day 60 (visit 3) and Day 90 (last visit 4))
- Insulin(baseline (visit 1), Day 30 (visit 2), Day 60 (visit 3) and Day 90 (last visit 4))
- Quantitative insulin sensitivity check index (QUICKI)(baseline (visit 1), Day 30 (visit 2), Day 60 (visit 3) and Day 90 (last visit 4))
- Homeostatic model assessment (HOMA)(baseline (visit 1), Day 30 (visit 2), Day 60 (visit 3) and Day 90 (last visit 4))
- low-density lipoprotein (LDL) cholesterol(baseline (visit 1), Day 30 (visit 2), Day 60 (visit 3) and Day 90 (last visit 4))
- Interleukin-1b(baseline (visit 1) and Day 90 (last visit 4))
- Triglycerides(baseline (visit 1), Day 30 (visit 2), Day 60 (visit 3) and Day 90 (last visit 4))
- Total cholesterol(baseline (visit 1), Day 30 (visit 2), Day 60 (visit 3) and Day 90 (last visit 4))
- non-high-density lipoprotein cholesterol (non-HDL)(baseline (visit 1), Day 30 (visit 2), Day 60 (visit 3) and Day 90 (last visit 4))
- Fatty acid pattern in red blood cells(baseline (visit 1), Day 30 (visit 2), Day 60 (visit 3) and Day 90 (last visit 4))
- Glomerular filtration rate (GFR)(baseline (visit 1), Day 30 (visit 2), Day 60 (visit 3) and Day 90 (last visit 4))
- % transferrin saturation(baseline (visit 1) and Day 90 (last visit 4))
- high-density lipoprotein (HDL) cholesterol(baseline (visit 1), Day 30 (visit 2), Day 60 (visit 3) and Day 90 (last visit 4))
- Fatty acid pattern plasma(baseline (visit 1), Day 30 (visit 2), Day 60 (visit 3) and Day 90 (last visit 4))
- Urea(baseline (visit 1), Day 30 (visit 2), Day 60 (visit 3) and Day 90 (last visit 4))
- Uric acid(baseline (visit 1), Day 30 (visit 2), Day 60 (visit 3) and Day 90 (last visit 4))
- Creatinine(baseline (visit 1), Day 30 (visit 2), Day 60 (visit 3) and Day 90 (last visit 4))
- Potassium (K)(baseline (visit 1), Day 30 (visit 2), Day 60 (visit 3) and Day 90 (last visit 4))
- Chlore (Cl)(baseline (visit 1), Day 30 (visit 2), Day 60 (visit 3) and Day 90 (last visit 4))
- Phosphate (P)(baseline (visit 1), Day 30 (visit 2), Day 60 (visit 3) and Day 90 (last visit 4))
- Alanine transaminase (ALAT)(baseline (visit 1), Day 30 (visit 2), Day 60 (visit 3) and Day 90 (last visit 4))
- Aspartate aminotransferase (ASAT)(baseline (visit 1), Day 30 (visit 2), Day 60 (visit 3) and Day 90 (last visit 4))
- Vitamin B12(baseline (visit 1) and Day 90 (last visit 4))
- Gamma-glutamyl transferase (GGT)(baseline (visit 1), Day 30 (visit 2), Day 60 (visit 3) and Day 90 (last visit 4))
- Alkaline phosphatase (ALP)(baseline (visit 1), Day 30 (visit 2), Day 60 (visit 3) and Day 90 (last visit 4))
- Lipase(baseline (visit 1), Day 30 (visit 2), Day 60 (visit 3) and Day 90 (last visit 4))
- Haemoglobin(baseline (visit 1), Day 30 (visit 2), Day 60 (visit 3) and Day 90 (last visit 4))
- White blood cells(baseline (visit 1), Day 30 (visit 2), Day 60 (visit 3) and Day 90 (last visit 4))
- Blood cell count(baseline (visit 1), Day 30 (visit 2), Day 60 (visit 3) and Day 90 (last visit 4))
- Mean corpuscular volume (MCV)(baseline (visit 1), Day 30 (visit 2), Day 60 (visit 3) and Day 90 (last visit 4))
- Mean corpuscular hemoglobin concentration (MCHC)(baseline (visit 1), Day 30 (visit 2), Day 60 (visit 3) and Day 90 (last visit 4))
- Red blood cells(baseline (visit 1), Day 30 (visit 2), Day 60 (visit 3) and Day 90 (last visit 4))
- Intestinal tolerance(baseline (visit 1), Day 30 (visit 2), Day 60 (visit 3) and Day 90 (last visit 4))
- Reticulocytes(baseline (visit 1), Day 30 (visit 2), Day 60 (visit 3) and Day 90 (last visit 4))
- Haematocrit(baseline (visit 1), Day 30 (visit 2), Day 60 (visit 3) and Day 90 (last visit 4))
- Body weight(baseline (visit 1), Day 30 (visit 2), Day 60 (visit 3) and Day 90 (last visit 4))
- Waist circumference(baseline (visit 1), Day 30 (visit 2), Day 60 (visit 3) and Day 90 (last visit 4))
- Hip circumference(baseline (visit 1), Day 30 (visit 2), Day 60 (visit 3) and Day 90 (last visit 4))
- Lean mass(baseline (visit 1), Day 30 (visit 2), Day 60 (visit 3) and Day 90 (last visit 4))
- Fat mass(baseline (visit 1), Day 30 (visit 2), Day 60 (visit 3) and Day 90 (last visit 4))
- Protein(baseline (visit 1) and Day 90 (last visit 4))
- Albumin(baseline (visit 1) and Day 90 (last visit 4))
- Visceral fat mass(baseline (visit 1), Day 30 (visit 2), Day 60 (visit 3) and Day 90 (last visit 4))
- International normalized ratio (INR)(baseline (visit 1) and Day 90 (last visit 4))
- Activated clotting time (ACT)(baseline (visit 1) and Day 90 (last visit 4))
- Iron(baseline (visit 1) and Day 90 (last visit 4))
- Transferrin(baseline (visit 1) and Day 90 (last visit 4))
- Ferritin(baseline (visit 1) and Day 90 (last visit 4))
- C-reactive protein (CRP)(baseline (visit 1) and Day 90 (last visit 4))
- Interleukin-6(baseline (visit 1) and Day 90 (last visit 4))
- Oxidized low-density lipoprotein (LDLox)(baseline (visit 1) and Day 90 (last visit 4))
- Systolic blood pressure(baseline (visit 1) and Day 90 (last visit 4))
- Diastolic blood pressure(baseline (visit 1) and Day 90 (last visit 4))
- Tumor necrosis factor alpha (TNFa)(baseline (visit 1) and Day 90 (last visit 4))
- Nitrosylated hemoglobin (HbNO)(baseline (visit 1) and Day 90 (last visit 4))
- Satiety(baseline (visit 1), Day 30 (visit 2), Day 60 (visit 3) and Day 90 (last visit 4))
- Quality of life 36-item short-form survey (SF36)(baseline (visit 1), Day 30 (visit 2), Day 60 (visit 3) and Day 90 (last visit 4))
- Augmentation index normalized for heart rate (AI@75bpm)(baseline (visit 1) and Day 90 (last visit 4))
- Glycated haemoglobin (HbA1c)(Day 30 (visit 2) and Day 60 (visit 3))