A Comparison Chocolate With and Without High Cocoa Solids in Patients With Type 2 Diabetes in a Randomised Clinical Trial

Not Applicable

Completed

Conditions: Diabetes Type 2

Interventions: Other: Cocoa Polyphenols

Registration Number: NCT01617603

Lead Sponsor: Société des Produits Nestlé (SPN)

Brief Summary: Type 2 diabetes is being acknowledged as a potential public health time bomb, whose incidence is predicted to double over the next 10 years in the UK, associated with the rise in obesity and increasing sedentary lifestyles. Increased insulin resistance has been shown to be an important feature of type 2 diabetes (especially in those presenting with obesity and in particular visceral or abdominal obesity). Insulin resistance is implicated as a risk factor of cardiovascular disease and may lead to pancreatic dysfunction through increased β-cell stress in the pancreas. A combination of insulin resistance and pancreatic beta cell failure then leads to type 2 diabetes. The main cause of morbidity and mortality in type 2 diabetes is cardiovascular disease as the condition is associated with impaired vascular functioning and increased levels of oxidation markers.

Epidemiological studies suggest dietary flavonoids decrease the risk of death from coronary heart disease, cancer, and stroke. Flavonoid-rich foods include fruits and vegetables as well as tea, red wine, and chocolate. In a cohort of elderly men, cocoa intake was inversely associated with blood pressure and 15-year cardiovascular and all-cause mortality. It has been reported that in healthy humans, consumption of flavanol-rich dark chocolate decreased daytime and night time blood pressure, reduced insulin resistance, and improved nitric oxide dependent vaso-relaxation. Another trial found that cocoa powder increased postprandial insulinaemia in lean young adults. These research papers have led to the hypothesis that chocolate containing high cocoa liquor may help to reduce the risk of developing type 2 diabetes.

This study is design as a double-blind, controlled, single center, randomized, parallel design clinical trial. The primary outcome measure is to compare parameters of insulin resistance and glycaemic control in volunteers with type 2 diabetes after consumption of 3 different chocolates (one dark and two milk chocolates) with a secondary outcome of endothelial function, cholesterol profile and oxidative stress. Subjects will undergo medical screening, anthropometry, physical activity and dietary assessments before randomization.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 62

Inclusion Criteria

Not provided

Exclusion Criteria

Patients with concurrent illness or any changes in medication in the last 3 months.
Patients whose diabetes is managed with TZDs, DPP-IV inhibitors, GLP-1 analogues, insulin or sulphonylureas or prandial regulators
Patients not wishing to allow disclosure to their GPs.
Pregnancy
Hba1c at recruiting stage of >10.0%
Patient who cannot be expected to comply with treatment
Currently participating or having participated in another clinical trial during the last 3 months prior to the beginning of this study
Patients who consuming more than 20g/d of chocolate or having a very high polyphenol content of their diet, who are not willing to change their diet
Patients taking high dose antioxidant supplements including single and multivitamin preparations including A,C,E.
Women on HRT treatment

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
High polyphenol milk chocolate	Cocoa Polyphenols	High polyphenol milk chocolate containing approximately 1 mg/g of epicatechin
Nestle Noir 70 % chocolate	Cocoa Polyphenols	Nestle Noir 70 % chocolate containing approximately 1 mg/g of epicatechin
Low polyphenol milk	Cocoa Polyphenols	Low polyphenol milk control (matched to product 1 as closely as possible for milk content, carbohydrate, fat and calories, made from cocoa butter, sugar, milk powder and small amount of cocoa liquor to improve taste, giving approximately 0.05mg/g epicatechin.

Primary Outcome Measures

Name	Time	Method
Difference in Insulin Resistance (HOMA) Between Treatments After 12 Weeks of Product Intake	84th day of product intake	HbA1c with measurement of plasma glucose and insulin (to determine HOMA index) at the 84th day after product intake minus value at baseline (1st day of product intake. Insulin resistance is defined by a HOMA index \> 2.4

Secondary Outcome Measures

Name	Time	Method
Endothelial Function After 12 Weeks of Product Intake	84th day of product intake	Endothelial function is assessed from arterial stiffness measurements at the 84th day minus the value at baseline (1st day of product intake)
Cholesterol Profile After 12 Weeks of Product Intake	84th day of product intake	Cholesterol profile is assessed from plasma HDL, LDL and total cholesterol measurements at the 84th day of product intake
Oxidative Stress After 12 Weeks of Product Intake	84th day of product intake	Oxidative stress is assessed from measurements of plasma markers (High sensitivity CRP, IL-1, IL-6, and alpha-TNF) at the 84th day of product intake

Trial Locations

Locations (1): Endocrinology, Diabetes & Metabolism, Hull York Medical School, Michael White Diabetes Centre, 220-236, Anlaby Road
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Hull, United Kingdom