Background
Monomeric and oligomeric flavanols and their physiological effect
Objective
Methods/design
Study design
Study population
Definition of T2D
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Fasting plasma glucose of at least 7.0 mmol/L, measured at at least two separate time points
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Non-fasting plasma glucose level of at least 11.1 mmol/L, measured at at least two separate time points
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HbA1c of at least 48 mmol/mol, measured at at least two separate time points
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Using anti-diabetic medication
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Diagnosis of T2D documented in the patient’s medical record by the designated physician.
Inclusion criteria
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T2D, as defined in the section above
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Age of 40–85 years
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Microalbuminuria in the previous 6 months (as microalbuminuria can change during time, results should not be older than 6 months), defined as one of the following:
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30–300 mg albumin in a 24-h urine sample
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or 3.5–35 mg albumin/mmol creatinine in females and 2.5–25 mg albumin/mmol creatinine in males in a urine portion.
Exclusion criteria
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Other types of diabetes mellitus as derived from the medical records
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Prior (less than 4 weeks before participating) or current use of any specific dietary supplementary products providing daily amounts of MOF of 25 mg/day or higher
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Anticoagulation medication
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Major health conditions: organ transplantation, untreated cancer, current chemotherapy or radiotherapy, or acute or chronic organ failure
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Microalbuminuria due to conditions other than T2D
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Pregnancy or lactation during the trial.
Randomization and blinding
Sample size calculation
Intervention and control
Formulation placebo | |
Sweetener (isomalt GS-PF; E953) | 1400 mg |
Food acid (citric acid; E330) | 200 mg |
Black tea extract | 150 mg |
Natural lemon flavor | 20 mg |
Anti-caking agent (tricalcium phosphate) E341(iii)) | 10 mg |
Acidity regulator (tripotassium citrate))) E332(ii)) | 10 mg |
Sweetener (sucralose; E955) | 10 mg |
Total | 1800 mg |
Formulation Endoclair® | |
Sweetener (isomalt GS-PF; E953) | 1400 mg |
Monomeric and oligomeric flavanols | 200 mg |
Food acid (citric acid; E330) | 200 mg |
Black tea extract | 150 mg |
Natural lemon flavor | 20 mg |
Anti-caking agent (tricalcium phosphate) E341(iii)) | 10 mg |
Acidity regulator (tripotassium citrate) E332(ii)) | 10 mg |
Sweetener (sucralose; E955) | 10 mg |
Total | 2000 mg |
Energy | 4.12 kcal |
Fat | 0.0 g |
Carbohydrates | 1.5 g (polyols) |
Protein | 0.0 g |
Sodium | 0.0 mg |