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

NCT01617603 | Completed Results DMC

• 1 other identifier: 07.52.NRC
• Study Type: interventional
• Target: 62
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetes Type 2

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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

  84th day of product intake

Secondary Outcomes (3)

• Endothelial Function After 12 Weeks of Product Intake

  84th day of product intake

• Cholesterol Profile After 12 Weeks of Product Intake

  84th day of product intake

• Oxidative Stress After 12 Weeks of Product Intake

  84th day of product intake

Study Arms (3)

High polyphenol milk chocolate

EXPERIMENTAL

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

Other: Cocoa Polyphenols

Nestle Noir 70 % chocolate

ACTIVE COMPARATOR

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

Other: Cocoa Polyphenols

Low polyphenol milk

PLACEBO COMPARATOR

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.

Other: Cocoa Polyphenols

Interventions

Cocoa Polyphenols OTHER

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

High polyphenol milk chocolate; Low polyphenol milk; Nestle Noir 70 % chocolate

Eligibility Criteria

• Age: 45 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Société des Produits Nestlé (SPN): lead

Study Sites (1)

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

Hull, HU3 2RW, United Kingdom

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Insulin Resistance

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Hyperinsulinism

Results Point of Contact

• Title: Prof. Stephen Atkin, Principal Investigator
• Organization: Medical School, Michael White Diabetes Centre, 220-236, Anlaby Road,

Stephen.Atkin@hyms.ac.uk

+44(0)1482 675312

Study Officials

• Stephen L Atkin, MD, Prof

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

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 1, 2012
• First Posted: June 12, 2012
• Study Start: April 1, 2009
• Primary Completion: April 1, 2011
• Study Completion: May 1, 2011
• Last Updated: July 19, 2013
• Results First Posted: July 1, 2013

Record last verified: 2013-07

Locations

GB (1)