Intestinal Tolerance & Health Effects of Daily Consumption of Two Eggs With Fatty Acid Profile Related to Metabolic Disorders (Oil4Egg)
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
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.
調査の概要
詳細な説明
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 .
During these monthly medical visits patients also completed the questionnaires assessing intestinal tolerance (visual analogue scale showing 10 gastrointestinal symptoms), satiety (visual analog scale questionnaire) and well-being (36 items short form survey). Eating habits were monitored using a food diary. Additional parameters were measured only during the first and the last visit: coagulation, nutritional status, endothelial function and inflammation.
研究の種類
入学 (実際)
段階
- 適用できない
連絡先と場所
研究場所
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Louvain-La-Neuve、ベルギー、1348
- Center of Investigation in Clinical Nutrition
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参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
- Satiety
- 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
研究計画
研究はどのように設計されていますか?
デザインの詳細
- 主な目的:防止
- 割り当て:ランダム化
- 介入モデル:並列代入
- マスキング:ダブル
武器と介入
参加者グループ / アーム |
介入・治療 |
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プラセボコンパレーター:Control
Consumption of two "classical eggs" per day during three months.
The fatty acid pattern of those eggs is characterized by: total saturated fatty acid 34.25%, total monounsaturated fatty acid 47.68%, total n-6 polyunsaturated fatty acid 16.97%, total n-3 polyunsaturated fatty acid 1.10%.
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Consumption of two eggs (control or test) per day during three months
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実験的:Test
Consumption of two test eggs per day during three months.
These eggs are naturally enriched in n-3 polyunsaturated fatty acids, conjugated-linoleic acids and conjugated-linolenic acids (total saturated fatty acid 31.74%,
total monounsaturated fatty acid 28.09%, total n-6 polyunsaturated fatty acid 16.07%, total n-3 polyunsaturated fatty acid 6.51%)
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Consumption of two eggs (control or test) per day during three months
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この研究は何を測定していますか?
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
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Glycated haemoglobin (HbA1c)
時間枠:Change from baseline (visit 1) glycated haemoglobin at 3 months (Day 90, visit 4)
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Glycated haemoglobin (HbA1c) in blood samples
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Change from baseline (visit 1) glycated haemoglobin at 3 months (Day 90, visit 4)
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
---|---|---|
Glucose
時間枠:baseline (visit 1), Day 30 (visit 2), Day 60 (visit 3) and Day 90 (last visit 4)
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blood samples
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baseline (visit 1), Day 30 (visit 2), Day 60 (visit 3) and Day 90 (last visit 4)
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Insulin
時間枠:baseline (visit 1), Day 30 (visit 2), Day 60 (visit 3) and Day 90 (last visit 4)
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blood samples
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baseline (visit 1), Day 30 (visit 2), Day 60 (visit 3) and Day 90 (last visit 4)
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Homeostatic model assessment (HOMA)
時間枠:baseline (visit 1), Day 30 (visit 2), Day 60 (visit 3) and Day 90 (last visit 4)
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blood samples
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baseline (visit 1), Day 30 (visit 2), Day 60 (visit 3) and Day 90 (last visit 4)
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Quantitative insulin sensitivity check index (QUICKI)
時間枠:baseline (visit 1), Day 30 (visit 2), Day 60 (visit 3) and Day 90 (last visit 4)
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blood samples
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baseline (visit 1), Day 30 (visit 2), Day 60 (visit 3) and Day 90 (last visit 4)
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Triglycerides
時間枠:baseline (visit 1), Day 30 (visit 2), Day 60 (visit 3) and Day 90 (last visit 4)
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blood samples
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baseline (visit 1), Day 30 (visit 2), Day 60 (visit 3) and Day 90 (last visit 4)
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Total cholesterol
時間枠:baseline (visit 1), Day 30 (visit 2), Day 60 (visit 3) and Day 90 (last visit 4)
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blood samples
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baseline (visit 1), Day 30 (visit 2), Day 60 (visit 3) and Day 90 (last visit 4)
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low-density lipoprotein (LDL) cholesterol
時間枠:baseline (visit 1), Day 30 (visit 2), Day 60 (visit 3) and Day 90 (last visit 4)
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blood samples
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baseline (visit 1), Day 30 (visit 2), Day 60 (visit 3) and Day 90 (last visit 4)
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high-density lipoprotein (HDL) cholesterol
時間枠:baseline (visit 1), Day 30 (visit 2), Day 60 (visit 3) and Day 90 (last visit 4)
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blood samples
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baseline (visit 1), Day 30 (visit 2), Day 60 (visit 3) and Day 90 (last visit 4)
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non-high-density lipoprotein cholesterol (non-HDL)
時間枠:baseline (visit 1), Day 30 (visit 2), Day 60 (visit 3) and Day 90 (last visit 4)
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blood samples
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baseline (visit 1), Day 30 (visit 2), Day 60 (visit 3) and Day 90 (last visit 4)
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Fatty acid pattern in red blood cells
時間枠:baseline (visit 1), Day 30 (visit 2), Day 60 (visit 3) and Day 90 (last visit 4)
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blood samples
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baseline (visit 1), Day 30 (visit 2), Day 60 (visit 3) and Day 90 (last visit 4)
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Fatty acid pattern plasma
時間枠:baseline (visit 1), Day 30 (visit 2), Day 60 (visit 3) and Day 90 (last visit 4)
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blood samples
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baseline (visit 1), Day 30 (visit 2), Day 60 (visit 3) and Day 90 (last visit 4)
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Urea
時間枠:baseline (visit 1), Day 30 (visit 2), Day 60 (visit 3) and Day 90 (last visit 4)
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blood samples
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baseline (visit 1), Day 30 (visit 2), Day 60 (visit 3) and Day 90 (last visit 4)
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Uric acid
時間枠:baseline (visit 1), Day 30 (visit 2), Day 60 (visit 3) and Day 90 (last visit 4)
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blood samples
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baseline (visit 1), Day 30 (visit 2), Day 60 (visit 3) and Day 90 (last visit 4)
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Creatinine
時間枠:baseline (visit 1), Day 30 (visit 2), Day 60 (visit 3) and Day 90 (last visit 4)
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blood samples
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baseline (visit 1), Day 30 (visit 2), Day 60 (visit 3) and Day 90 (last visit 4)
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Glomerular filtration rate (GFR)
時間枠:baseline (visit 1), Day 30 (visit 2), Day 60 (visit 3) and Day 90 (last visit 4)
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blood samples
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baseline (visit 1), Day 30 (visit 2), Day 60 (visit 3) and Day 90 (last visit 4)
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Sodium (Na)
時間枠:baseline (visit 1), Day 30 (visit 2), Day 60 (visit 3) and Day 90 (last visit 4)
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blood samples
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baseline (visit 1), Day 30 (visit 2), Day 60 (visit 3) and Day 90 (last visit 4)
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Potassium (K)
時間枠:baseline (visit 1), Day 30 (visit 2), Day 60 (visit 3) and Day 90 (last visit 4)
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blood samples
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baseline (visit 1), Day 30 (visit 2), Day 60 (visit 3) and Day 90 (last visit 4)
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Chlore (Cl)
時間枠:baseline (visit 1), Day 30 (visit 2), Day 60 (visit 3) and Day 90 (last visit 4)
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blood samples
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baseline (visit 1), Day 30 (visit 2), Day 60 (visit 3) and Day 90 (last visit 4)
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Phosphate (P)
時間枠:baseline (visit 1), Day 30 (visit 2), Day 60 (visit 3) and Day 90 (last visit 4)
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blood samples
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baseline (visit 1), Day 30 (visit 2), Day 60 (visit 3) and Day 90 (last visit 4)
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Alanine transaminase (ALAT)
時間枠:baseline (visit 1), Day 30 (visit 2), Day 60 (visit 3) and Day 90 (last visit 4)
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blood samples
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baseline (visit 1), Day 30 (visit 2), Day 60 (visit 3) and Day 90 (last visit 4)
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Aspartate aminotransferase (ASAT)
時間枠:baseline (visit 1), Day 30 (visit 2), Day 60 (visit 3) and Day 90 (last visit 4)
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blood samples
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baseline (visit 1), Day 30 (visit 2), Day 60 (visit 3) and Day 90 (last visit 4)
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Gamma-glutamyl transferase (GGT)
時間枠:baseline (visit 1), Day 30 (visit 2), Day 60 (visit 3) and Day 90 (last visit 4)
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blood samples
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baseline (visit 1), Day 30 (visit 2), Day 60 (visit 3) and Day 90 (last visit 4)
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Alkaline phosphatase (ALP)
時間枠:baseline (visit 1), Day 30 (visit 2), Day 60 (visit 3) and Day 90 (last visit 4)
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blood samples
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baseline (visit 1), Day 30 (visit 2), Day 60 (visit 3) and Day 90 (last visit 4)
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Lipase
時間枠:baseline (visit 1), Day 30 (visit 2), Day 60 (visit 3) and Day 90 (last visit 4)
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blood samples
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baseline (visit 1), Day 30 (visit 2), Day 60 (visit 3) and Day 90 (last visit 4)
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Haemoglobin
時間枠:baseline (visit 1), Day 30 (visit 2), Day 60 (visit 3) and Day 90 (last visit 4)
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blood samples
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baseline (visit 1), Day 30 (visit 2), Day 60 (visit 3) and Day 90 (last visit 4)
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Mean corpuscular volume (MCV)
時間枠:baseline (visit 1), Day 30 (visit 2), Day 60 (visit 3) and Day 90 (last visit 4)
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blood samples
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baseline (visit 1), Day 30 (visit 2), Day 60 (visit 3) and Day 90 (last visit 4)
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Mean corpuscular hemoglobin concentration (MCHC)
時間枠:baseline (visit 1), Day 30 (visit 2), Day 60 (visit 3) and Day 90 (last visit 4)
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blood samples
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baseline (visit 1), Day 30 (visit 2), Day 60 (visit 3) and Day 90 (last visit 4)
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Red blood cells
時間枠:baseline (visit 1), Day 30 (visit 2), Day 60 (visit 3) and Day 90 (last visit 4)
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blood samples
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baseline (visit 1), Day 30 (visit 2), Day 60 (visit 3) and Day 90 (last visit 4)
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White blood cells
時間枠:baseline (visit 1), Day 30 (visit 2), Day 60 (visit 3) and Day 90 (last visit 4)
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blood samples
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baseline (visit 1), Day 30 (visit 2), Day 60 (visit 3) and Day 90 (last visit 4)
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Blood cell count
時間枠:baseline (visit 1), Day 30 (visit 2), Day 60 (visit 3) and Day 90 (last visit 4)
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blood samples
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baseline (visit 1), Day 30 (visit 2), Day 60 (visit 3) and Day 90 (last visit 4)
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Reticulocytes
時間枠:baseline (visit 1), Day 30 (visit 2), Day 60 (visit 3) and Day 90 (last visit 4)
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blood samples
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baseline (visit 1), Day 30 (visit 2), Day 60 (visit 3) and Day 90 (last visit 4)
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Haematocrit
時間枠:baseline (visit 1), Day 30 (visit 2), Day 60 (visit 3) and Day 90 (last visit 4)
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blood samples
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baseline (visit 1), Day 30 (visit 2), Day 60 (visit 3) and Day 90 (last visit 4)
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Body weight
時間枠:baseline (visit 1), Day 30 (visit 2), Day 60 (visit 3) and Day 90 (last visit 4)
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Impedancemeter
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baseline (visit 1), Day 30 (visit 2), Day 60 (visit 3) and Day 90 (last visit 4)
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Waist circumference
時間枠:baseline (visit 1), Day 30 (visit 2), Day 60 (visit 3) and Day 90 (last visit 4)
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Measuring tape
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baseline (visit 1), Day 30 (visit 2), Day 60 (visit 3) and Day 90 (last visit 4)
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Hip circumference
時間枠:baseline (visit 1), Day 30 (visit 2), Day 60 (visit 3) and Day 90 (last visit 4)
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Measuring tape
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baseline (visit 1), Day 30 (visit 2), Day 60 (visit 3) and Day 90 (last visit 4)
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Fat mass
時間枠:baseline (visit 1), Day 30 (visit 2), Day 60 (visit 3) and Day 90 (last visit 4)
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Impedancemeter
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baseline (visit 1), Day 30 (visit 2), Day 60 (visit 3) and Day 90 (last visit 4)
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Lean mass
時間枠:baseline (visit 1), Day 30 (visit 2), Day 60 (visit 3) and Day 90 (last visit 4)
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Impedancemeter
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baseline (visit 1), Day 30 (visit 2), Day 60 (visit 3) and Day 90 (last visit 4)
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Visceral fat mass
時間枠:baseline (visit 1), Day 30 (visit 2), Day 60 (visit 3) and Day 90 (last visit 4)
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Impedancemeter
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baseline (visit 1), Day 30 (visit 2), Day 60 (visit 3) and Day 90 (last visit 4)
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International normalized ratio (INR)
時間枠:baseline (visit 1) and Day 90 (last visit 4)
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blood samples
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baseline (visit 1) and Day 90 (last visit 4)
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Activated clotting time (ACT)
時間枠:baseline (visit 1) and Day 90 (last visit 4)
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blood samples
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baseline (visit 1) and Day 90 (last visit 4)
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Iron
時間枠:baseline (visit 1) and Day 90 (last visit 4)
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blood samples
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baseline (visit 1) and Day 90 (last visit 4)
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Transferrin
時間枠:baseline (visit 1) and Day 90 (last visit 4)
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blood samples
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baseline (visit 1) and Day 90 (last visit 4)
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Ferritin
時間枠:baseline (visit 1) and Day 90 (last visit 4)
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blood samples
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baseline (visit 1) and Day 90 (last visit 4)
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% transferrin saturation
時間枠:baseline (visit 1) and Day 90 (last visit 4)
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blood samples
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baseline (visit 1) and Day 90 (last visit 4)
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Vitamin B12
時間枠:baseline (visit 1) and Day 90 (last visit 4)
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blood samples
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baseline (visit 1) and Day 90 (last visit 4)
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25-hydroxy-vitamin D
時間枠:baseline (visit 1) and Day 90 (last visit 4)
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blood samples
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baseline (visit 1) and Day 90 (last visit 4)
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Protein
時間枠:baseline (visit 1) and Day 90 (last visit 4)
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blood samples
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baseline (visit 1) and Day 90 (last visit 4)
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Albumin
時間枠:baseline (visit 1) and Day 90 (last visit 4)
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blood samples
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baseline (visit 1) and Day 90 (last visit 4)
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C-reactive protein (CRP)
時間枠:baseline (visit 1) and Day 90 (last visit 4)
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blood samples
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baseline (visit 1) and Day 90 (last visit 4)
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Interleukin-6
時間枠:baseline (visit 1) and Day 90 (last visit 4)
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blood samples
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baseline (visit 1) and Day 90 (last visit 4)
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Interleukin-1b
時間枠:baseline (visit 1) and Day 90 (last visit 4)
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blood samples
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baseline (visit 1) and Day 90 (last visit 4)
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Tumor necrosis factor alpha (TNFa)
時間枠:baseline (visit 1) and Day 90 (last visit 4)
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blood samples
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baseline (visit 1) and Day 90 (last visit 4)
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Oxidized low-density lipoprotein (LDLox)
時間枠:baseline (visit 1) and Day 90 (last visit 4)
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blood samples
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baseline (visit 1) and Day 90 (last visit 4)
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Nitrosylated hemoglobin (HbNO)
時間枠:baseline (visit 1) and Day 90 (last visit 4)
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blood samples
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baseline (visit 1) and Day 90 (last visit 4)
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Satiety
時間枠:baseline (visit 1), Day 30 (visit 2), Day 60 (visit 3) and Day 90 (last visit 4)
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visual analog scale questionnaire
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baseline (visit 1), Day 30 (visit 2), Day 60 (visit 3) and Day 90 (last visit 4)
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Intestinal tolerance
時間枠:baseline (visit 1), Day 30 (visit 2), Day 60 (visit 3) and Day 90 (last visit 4)
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visual analog scale questionnaire
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baseline (visit 1), Day 30 (visit 2), Day 60 (visit 3) and Day 90 (last visit 4)
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Quality of life 36-item short-form survey (SF36)
時間枠:baseline (visit 1), Day 30 (visit 2), Day 60 (visit 3) and Day 90 (last visit 4)
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SF36 questionnaire
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baseline (visit 1), Day 30 (visit 2), Day 60 (visit 3) and Day 90 (last visit 4)
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Reactive hyperemia index (LnRHI)
時間枠:baseline (visit 1) and Day 90 (last visit 4)
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Tonometry
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baseline (visit 1) and Day 90 (last visit 4)
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Augmentation index normalized for heart rate (AI@75bpm)
時間枠:baseline (visit 1) and Day 90 (last visit 4)
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Tonometry
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baseline (visit 1) and Day 90 (last visit 4)
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Systolic blood pressure
時間枠:baseline (visit 1) and Day 90 (last visit 4)
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Tensiometer
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baseline (visit 1) and Day 90 (last visit 4)
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Diastolic blood pressure
時間枠:baseline (visit 1) and Day 90 (last visit 4)
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Tensiometer
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baseline (visit 1) and Day 90 (last visit 4)
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Glycated haemoglobin (HbA1c)
時間枠:Day 30 (visit 2) and Day 60 (visit 3)
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Glycated haemoglobin in blood sample
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Day 30 (visit 2) and Day 60 (visit 3)
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協力者と研究者
捜査官
- スタディディレクター:Yvan Larondelle, Prof、Université Catholique de Louvain
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。