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

Primary Purpose

Diabetes Type 2

Status

Completed

Phase

Not Applicable

Locations

United Kingdom

Study Type

Interventional

Intervention

Cocoa Polyphenols

About this trial

This is an interventional prevention trial for Diabetes Type 2 focused on measuring diabetes type 2, insulin resistance, glycaemic control, Endothelial function, Cocoa Polyphenols

Eligibility Criteria

45 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion criteria:

The diagnosis of type 2 diabetes will be based on the WHO guidelines. These are 2 fasting plasma glucose readings of greater than 7.0mmoll-1 or 2 random plasma glucose readings >11mmoll-1 in the absence of symptoms or concurrent illness or medication which might lead to hyperglycaemia (e.g. thiazide diuretics). Or one reading meeting the diagnostic level with the presence of symptoms of polyuria, polydipsia, nocturia, fatigue or blurring of vision. The final diagnostic method of diagnosis type 2 diabetes is a positive oral glucose tolerance test (OGTT) using a 75g glucose load. If doubt exists on the diagnosis of diabetes an OGTT will be performed.
Diabetes managed by diet alone or diet and metformin. If metformin is used the dose should have been stable for a minimum of 3 months prior to the start of the study.
Hba1c up to and including 9.9%
Age 45-75
If female, should be post-menopausal
BMI 25-39kgm-2
Patients will have attended a structured group patient education programme (and be on stable medication for hypertension, lipids and gout (if appropriate) for 3 months prior to entry into the study. Subjects will be encouraged to incorporate the chocolate into their diet as advised during the education programme
Having obtained his/her or his/her legal representative's informed consent.

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

Sites / Locations

Endocrinology, Diabetes & Metabolism, Hull York Medical School, Michael White Diabetes Centre, 220-236, Anlaby Road

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Placebo Comparator

Arm Label

High polyphenol milk chocolate

Nestle Noir 70 % chocolate

Low polyphenol milk

Arm Description

High polyphenol milk chocolate containing approximately 1 mg/g of epicatechin

Nestle Noir 70 % chocolate containing approximately 1 mg/g of epicatechin

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.

Outcomes

Primary Outcome Measures

Difference in Insulin Resistance (HOMA) Between Treatments After 12 Weeks 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

Endothelial Function After 12 Weeks 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

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

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

Full Information

NCT ID

NCT01617603

First Posted

June 1, 2012

Last Updated

July 5, 2013

Sponsor

Société des Produits Nestlé (SPN)

1. Study Identification

Unique Protocol Identification Number

NCT01617603

Brief Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

July 2013

Overall Recruitment Status

Completed

Study Start Date

April 2009 (undefined)

Primary Completion Date

April 2011 (Actual)

Study Completion Date

May 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Société des Produits Nestlé (SPN)

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Diabetes Type 2

Keywords

diabetes type 2, insulin resistance, glycaemic control, Endothelial function, Cocoa Polyphenols

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

62 (Actual)

8. Arms, Groups, and Interventions

Arm Title

High polyphenol milk chocolate

Arm Type

Experimental

Arm Description

High polyphenol milk chocolate containing approximately 1 mg/g of epicatechin

Arm Title

Nestle Noir 70 % chocolate

Arm Type

Active Comparator

Arm Description

Nestle Noir 70 % chocolate containing approximately 1 mg/g of epicatechin

Arm Title

Low polyphenol milk

Arm Type

Placebo Comparator

Arm Description

Intervention Type

Other

Intervention Name(s)

Cocoa Polyphenols

Intervention Description

20g/d of product, two active products provide 20 mg/d epicatechin, on visiting occasions, an acute dose of 40g product to be given

Primary Outcome Measure Information:

Title

Difference in Insulin Resistance (HOMA) Between Treatments After 12 Weeks of Product Intake

Description

Time Frame

84th day of product intake

Secondary Outcome Measure Information:

Title

Endothelial Function After 12 Weeks of Product Intake

Description

Endothelial function is assessed from arterial stiffness measurements at the 84th day minus the value at baseline (1st day of product intake)

Time Frame

84th day of product intake

Title

Cholesterol Profile After 12 Weeks of Product Intake

Description

Cholesterol profile is assessed from plasma HDL, LDL and total cholesterol measurements at the 84th day of product intake

Time Frame

84th day of product intake

Title

Oxidative Stress After 12 Weeks of Product Intake

Description

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

Time Frame

84th day of product intake

10. Eligibility

Sex

All

Minimum Age & Unit of Time

45 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion criteria: The diagnosis of type 2 diabetes will be based on the WHO guidelines. These are 2 fasting plasma glucose readings of greater than 7.0mmoll-1 or 2 random plasma glucose readings >11mmoll-1 in the absence of symptoms or concurrent illness or medication which might lead to hyperglycaemia (e.g. thiazide diuretics). Or one reading meeting the diagnostic level with the presence of symptoms of polyuria, polydipsia, nocturia, fatigue or blurring of vision. The final diagnostic method of diagnosis type 2 diabetes is a positive oral glucose tolerance test (OGTT) using a 75g glucose load. If doubt exists on the diagnosis of diabetes an OGTT will be performed. Diabetes managed by diet alone or diet and metformin. If metformin is used the dose should have been stable for a minimum of 3 months prior to the start of the study. Hba1c up to and including 9.9% Age 45-75 If female, should be post-menopausal BMI 25-39kgm-2 Patients will have attended a structured group patient education programme (and be on stable medication for hypertension, lipids and gout (if appropriate) for 3 months prior to entry into the study. Subjects will be encouraged to incorporate the chocolate into their diet as advised during the education programme Having obtained his/her or his/her legal representative's informed consent. 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Stephen L Atkin, MD, Prof

Organizational Affiliation

Head of Academic Endocrinology, Diabetes & Metabolism; Hull York Medical School; Michael White Diabetes Centre, Hull, UK

Official's Role

Principal Investigator

Facility Information:

Facility Name

Endocrinology, Diabetes & Metabolism, Hull York Medical School, Michael White Diabetes Centre, 220-236, Anlaby Road

City

Hull

ZIP/Postal Code

HU3 2RW

Country

United Kingdom

12. IPD Sharing Statement

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

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