Dietary Polyphenols and Glycation in Renal Insufficiency

NCT ID: NCT02524938

Last Updated: 2023-02-10

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 9 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-06-01
• Study Completion Date: 2022-09-30

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.

Conditions

Diabetes Mellitus, Type 2; Renal Insufficiency, Chronic

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Treatment group

Chlorogenic Acid (CGA) 400mg/day (CGA-enriched coffee)

Group Type: EXPERIMENTAL

Chlorogenic Acid (CGA) enriched coffee

Intervention Type: DIETARY_SUPPLEMENT

Chlorogenic Acid (CGA) enriched coffee Phase I: CGA-enriched coffee provided with a CGA content of 70-90 mg/100g. Daily CGA intake of 400mg.

Phase II: recommendation for achieving a CGA-rich diet of at least 400mg/day (total polyphenol intake of at least 1g/day)

Control group

Conventional coffee (habitual diet)

Group Type: SHAM_COMPARATOR

Conventional coffee

Intervention Type: DIETARY_SUPPLEMENT

Phase I: conventional coffee provided (low in CGA) Phase II: standard dietary advice

Interventions

Chlorogenic Acid (CGA) enriched coffee

Chlorogenic Acid (CGA) enriched coffee Phase I: CGA-enriched coffee provided with a CGA content of 70-90 mg/100g. Daily CGA intake of 400mg.

Phase II: recommendation for achieving a CGA-rich diet of at least 400mg/day (total polyphenol intake of at least 1g/day)

Intervention Type: DIETARY_SUPPLEMENT

Conventional coffee

Phase I: conventional coffee provided (low in CGA) Phase II: standard dietary advice

Intervention Type: DIETARY_SUPPLEMENT

Other Intervention Names

CGA-enriched diet; Habitual diet

Eligibility Criteria

Inclusion Criteria

• type 2 Diabetes Mellitus
• chronic renal insufficiency with persistent eGFR of 35-60mL/min for at least three months
• fluent in English

Exclusion Criteria

• 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

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Glasgow

OTHER

Sponsor Role: collaborator

NHS Greater Glasgow and Clyde

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Emilie Combet, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Glasgow

Locations

NHS Greater Glasgow and Clyde

Glasgow, , United Kingdom

University of Glasgow

Glasgow, , United Kingdom

Countries

United Kingdom

Other Identifiers

GN15DI242

Identifier Type: -

Identifier Source: org_study_id