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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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ClinicalTrials.gov Identifier: NCT01617603
Recruitment Status : Completed
First Posted : June 12, 2012
Results First Posted : July 1, 2013
Last Update Posted : July 19, 2013
Sponsor:
Information provided by (Responsible Party):
Nestlé

Tracking Information
First Submitted Date  ICMJE June 1, 2012
First Posted Date  ICMJE June 12, 2012
Results First Submitted Date  ICMJE April 2, 2013
Results First Posted Date  ICMJE July 1, 2013
Last Update Posted Date July 19, 2013
Study Start Date  ICMJE April 2009
Actual Primary Completion Date April 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 5, 2013)
Difference in Insulin Resistance (HOMA) Between Treatments After 12 Weeks of Product Intake [ Time Frame: 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
Original Primary Outcome Measures  ICMJE
 (submitted: June 8, 2012)
Change in insulin resistance(HOMA)from baseline to 12th week [ Time Frame: D0 (baseline), D28 and D114 ]
HbA1c with measurement of plasma glucose and insulin (to determine HOMA) from baseline to the 12th week of product intake
Change History Complete list of historical versions of study NCT01617603 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: May 24, 2013)
  • Endothelial Function After 12 Weeks of Product Intake [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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
Original Secondary Outcome Measures  ICMJE
 (submitted: June 8, 2012)
  • Endothelial function from baseline to the 12th week of product intake [ Time Frame: D0, D28, D114 ]
    Endothelial function is assessed from arterial stiffness measurements
  • Cholesterol profile from baseline to the 12th week of product intake [ Time Frame: D0, D28, D114 ]
    Cholesterol profile is assessed from plasma HDL, LDL and total cholesterol measurements
  • Oxidative stress from baseline to the 12 week of product intake [ Time Frame: D0, D28, D114 ]
    Oxidative stress is assessed from measurements of plasma markers (High sensitivity CRP, IL-1, IL-6, and alpha-TNF)
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Comparison Chocolate With and Without High Cocoa Solids in Patients With Type 2 Diabetes in a Randomised Clinical Trial
Official Title  ICMJE Not Provided
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 Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Condition  ICMJE Diabetes Type 2
Intervention  ICMJE Other: Cocoa Polyphenols
20g/d of product, two active products provide 20 mg/d epicatechin, on visiting occasions, an acute dose of 40g product to be given
Study Arms  ICMJE
  • Experimental: High polyphenol milk chocolate
    High polyphenol milk chocolate containing approximately 1 mg/g of epicatechin
    Intervention: Other: Cocoa Polyphenols
  • Active Comparator: Nestle Noir 70 % chocolate
    Nestle Noir 70 % chocolate containing approximately 1 mg/g of epicatechin
    Intervention: Other: Cocoa Polyphenols
  • Placebo Comparator: Low polyphenol milk
    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.
    Intervention: Other: Cocoa Polyphenols
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 5, 2013)
62
Original Actual Enrollment  ICMJE
 (submitted: June 8, 2012)
60
Actual Study Completion Date  ICMJE May 2011
Actual Primary Completion Date April 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 45 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01617603
Other Study ID Numbers  ICMJE 07.52.NRC
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Nestlé
Study Sponsor  ICMJE Nestlé
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Stephen L Atkin, MD, Prof Head of Academic Endocrinology, Diabetes & Metabolism; Hull York Medical School; Michael White Diabetes Centre, Hull, UK
PRS Account Nestlé
Verification Date July 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP