NCT02524938

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
9

participants targeted

Target at below P25 for not_applicable diabetes-mellitus-type-2

Timeline
Completed

Started Jun 2016

Longer than P75 for not_applicable diabetes-mellitus-type-2

Geographic Reach
1 country

2 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 14, 2015

Completed
1 month until next milestone

First Posted

Study publicly available on registry

August 17, 2015

Completed
10 months until next milestone

Study Start

First participant enrolled

June 1, 2016

Completed
6.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2022

Completed
Last Updated

February 10, 2023

Status Verified

February 1, 2023

Enrollment Period

6.3 years

First QC Date

July 14, 2015

Last Update Submit

February 8, 2023

Conditions

Diabetes Mellitus, Type 2Renal Insufficiency, Chronic

Keywords

Dietary polyphenolsProtein glycation

Outcome Measures

Primary Outcomes (2)

  • Change in glycohaemoglobin (HbA1c)

    3 months

  • Change in estimated glomerular filtration rate (eGFR)

    21 months

Secondary Outcomes (17)

  • Change in fasting glucose

    3 months

  • Change in fructosamine

    3 months

  • Change in advanced glycation end product (AGE)

    3 months

  • Change in soluble receptor for AGE (sRAGE)

    3 months

  • Change in F2-isoprostane

    3 months

  • +12 more secondary outcomes

Study Arms (2)

Treatment group

EXPERIMENTAL

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

Dietary Supplement: Chlorogenic Acid (CGA) enriched coffee

Control group

SHAM COMPARATOR

Conventional coffee (habitual diet)

Dietary Supplement: Conventional coffee

Interventions

Chlorogenic Acid (CGA) enriched coffeeDIETARY_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)

Also known as: CGA-enriched diet
Treatment group
Conventional coffeeDIETARY_SUPPLEMENT

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

Also known as: Habitual diet
Control group

Eligibility Criteria

Age40 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

NHS Greater Glasgow and Clyde

Glasgow, United Kingdom

Location

University of Glasgow

Glasgow, United Kingdom

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2Renal Insufficiency, Chronic

Interventions

Chlorogenic Acid

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesRenal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

CinnamatesAcids, CarbocyclicCarboxylic AcidsOrganic ChemicalsCyclohexanecarboxylic Acids

Study Officials

  • Emilie Combet, PhD

    University of Glasgow

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 14, 2015

First Posted

August 17, 2015

Study Start

June 1, 2016

Primary Completion

September 1, 2022

Study Completion

September 1, 2022

Last Updated

February 10, 2023

Record last verified: 2023-02

Locations

GB(2)