Dietary Polyphenols and Glycation in Renal Insufficiency
- Conditions
- Diabetes Mellitus, Type 2Renal Insufficiency, Chronic
- Interventions
- Dietary Supplement: Chlorogenic Acid (CGA) enriched coffeeDietary Supplement: Conventional coffee
- Registration Number
- NCT02524938
- Lead Sponsor
- NHS Greater Glasgow and Clyde
- Brief Summary
Type 2 diabetes mellitus (T2DM) is associated with an increased risk of kidney failure, with high levels of glycohaemoglobin (HbA1c) presenting a sharper decline in renal function and an increase in the risk of mortality and end-stage renal disease (ESRD). Polyphenols may improve renal insufficiency in patients with diabetes with chlorogenic acids (CGA) one of the principle polyphenol groups in the diet - coffee/tea, stone fruits (especially plums/prunes) and some vegetables (artichoke, chicory). CGA (3-4 cups of coffee) has been associated with 25% lower risk of T2DM and a favourable reduction of HbA1c, blood pressure, and oxidative stress levels. This randomised controlled trial, therefore, aims to evaluate the effect of high CGA food on glycation and oxidative stress in T2DM subjects with early renal insufficiency (glomerular filtration rate of 35-60 mL/min) as well as progression of renal insufficiency and the risk of cardiovascular diseases.
The study will have two phases - phase I, an interventional study of 3 months followed by phase II, an observational study of 21 months.
In phase I, subjects will be randomized into 2 groups: CGA-enriched diet group, or control (habitual) diet group. The treatment group will be provided with a chlorogenic acid-rich food (coffee) with instructions to achieve an intake of 400 mg per day (equivalent to 3-4 coffee cups per day) for 12 weeks. The control group will receive a conventional coffee low in chlorogenic acid.
Participants will attend three sessions during phase I; baseline, 6 weeks, and 12 weeks. At baseline, general information, medical history, dietary habits and medication use will be recorded and a Food Frequency Questionnaire completed. Urine and blood samples will be collected and blood pressure, waist circumference, height and weight recorded. Participants' diet over the previous 3 days will be assessed by estimated food diary analysis.
In phase II, written dietary recommendations will be provided at three time points (months 6, 12 and 24) - treatment group to achieve a CGA-rich diet (total polyphenol intake of at least 1g per day, and at least 400mg per day of CGA) and standard dietary advice for the control group. Anthropometric/dietary data will be collected as well as blood and urine samples to assess markers of renal function, glycation and oxidative stress, and proteomic markers of cardiovascular disease, coronary artery disease and diabetes.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 9
- type 2 Diabetes Mellitus
- chronic renal insufficiency with persistent eGFR of 35-60mL/min for at least three months
- fluent in English
- dialysis therapy (current or previous)
- malignancy
- transplant recipient
- hyperthyroidism
- hypothyroidism
- high dose glucocorticoids (≥250 mg)
- body mass index (BMI) ≥ 45 kg/m2
- special dietary requirements
- take creatine, antioxidants or vitamin supplements
- smoker
- pregnant
- consume >4 cups of tea/coffee per day
- consume >5 portion of fruits and vegetables per day
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Treatment group Chlorogenic Acid (CGA) enriched coffee Chlorogenic Acid (CGA) 400mg/day (CGA-enriched coffee) Control group Conventional coffee Conventional coffee (habitual diet)
- Primary Outcome Measures
Name Time Method Change in estimated glomerular filtration rate (eGFR) 21 months Change in glycohaemoglobin (HbA1c) 3 months
- Secondary Outcome Measures
Name Time Method Change in fasting glucose 3 months Change in fructosamine 3 months Change in creatinine 21 months Change in soluble receptor for AGE (sRAGE) 3 months Change in F2-isoprostane 3 months Change in cholesterol 21 months Change in 8hydroxy 2'deoxyguanoside (8OhdG) 21 months Change in advanced glycation end product (AGE) 3 months Change in thiobarbituric acid reactive substances (TBARS) 21 months Change in malondialdehyde (MDA) 3 months Change in Interleukin-6 21 months Change in Urinary Albumin Excretion 21 months Change in blood pressure 21 months Change in crystatin C 21 months Change in fibrinogen 21 months Change in C-reactive protein 21 months Change in advanced oxidation protein products (AOPP) 21 months
Trial Locations
- Locations (2)
University of Glasgow
🇬🇧Glasgow, United Kingdom
NHS Greater Glasgow and Clyde
🇬🇧Glasgow, United Kingdom