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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

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Prevention
Condition Diabetes Type 2
Intervention Other: Cocoa Polyphenols
Enrollment 62
Recruitment Details 62 subjects were recruited. The intention-to-treat (ITT) set comprised of all the subjects who completed V4. One subject joined another trial after recruitment while two other subjects dropped out in course of the trial. These three subjects were not included in the full analysis population. Finally, PP dataset comprised of n = 48.
Pre-assignment Details Two subjects withdrew their consent quickly after giving it and were replaced so that the total number of recruited subjects was 62. Patients were randomly assigned to one of the three groups using age and gender as the stratification factors. The randomization was performed using the software TRIALSYS (developed internally at Nestlé).
Arm/Group Title High Polyphenol Milk Chocolate Low Polyphenol Milk Nestle Noir 70 % Chocolate
Hide Arm/Group Description

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

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

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.

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

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

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

Period Title: Overall Study
Started 20 21 21
Completed 17 19 20
Not Completed 3 2 1
Arm/Group Title High Polyphenol Milk Chocolate Low Polyphenol Milk Nestle Noir 70 % Chocolate Total
Hide Arm/Group Description

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

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

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.

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

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

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

Total of all reporting groups
Overall Number of Baseline Participants 20 21 21 62
Hide Baseline Analysis Population Description
[Not Specified]
Age, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 20 participants 21 participants 21 participants 62 participants
<= 45 years 0 0 0 0
Between 45 and 75 years 20 21 21 62
>=75 years 0 0 0 0
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 20 participants 21 participants 21 participants 62 participants
Female
10
  50.0%
11
  52.4%
10
  47.6%
31
  50.0%
Male
10
  50.0%
10
  47.6%
11
  52.4%
31
  50.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United Kingdom Number Analyzed 20 participants 21 participants 21 participants 62 participants
20 21 21 62
HOMA at the begining of product intake   [1] 
Mean (Inter-Quartile Range)
Unit of measure:  HOMA index
Number Analyzed 20 participants 21 participants 21 participants 62 participants
6.50
(4.14 to 10.21)
4.63
(2.77 to 7.74)
4.45
(3.19 to 6.21)
5.19
(2.77 to 10.21)
[1]
Measure Description:

Baseline HOMA (Homeostatic Model Assessment)index was evaluated at V1 (visit 1) scheduled 28 days after the screening visit (V0) without any chocolate intake. HOMA reflects the resistance to insulin and is obtained from glucose and insulin plasma concentrations at a given sampling timepoint, based on the following formula:

HOMA = Glucose (in mmol/L) X Insulin ( in mU/L)/ 22.5. Insulin resistance is defined by a HOMA index > 2.4. The highest the HOMA index is, the more pronounced the resistance to insulin is.

1.Primary Outcome
Title Difference in Insulin Resistance (HOMA) Between Treatments After 12 Weeks of Product Intake
Hide Description 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
Time Frame 84th day of product intake
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title High Polyphenol Milk Chocolate Low Polyphenol Milk Nestle Noir 70 % Chocolate
Hide Arm/Group Description:

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

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

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.

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

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

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

Overall Number of Participants Analyzed 17 19 20
Mean (Inter-Quartile Range)
Unit of Measure: HOMA index
2.82
(1.93 to 4.14)
2.21
(1.50 to 3.26)
2.75
(1.72 to 4.42)
2.Secondary Outcome
Title Endothelial Function After 12 Weeks of Product Intake
Hide 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
Outcome Measure Data Not Reported
3.Secondary Outcome
Title Cholesterol Profile After 12 Weeks of Product Intake
Hide 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
Outcome Measure Data Not Reported
4.Secondary Outcome
Title Oxidative Stress After 12 Weeks of Product Intake
Hide 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
Outcome Measure Data Not Reported
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title High Polyphenol Milk Chocolate Low Polyphenol Milk Nestle Noir 70 % Chocolate
Hide Arm/Group Description

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

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

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.

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

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

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

All-Cause Mortality
High Polyphenol Milk Chocolate Low Polyphenol Milk Nestle Noir 70 % Chocolate
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
High Polyphenol Milk Chocolate Low Polyphenol Milk Nestle Noir 70 % Chocolate
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/20 (5.00%)      1/21 (4.76%)      0/21 (0.00%)    
Cardiac disorders       
Pacemaker installation * [1]  0/20 (0.00%)  0 1/21 (4.76%)  1 0/21 (0.00%)  0
Renal and urinary disorders       
Cyst resection * [2]  1/20 (5.00%)  1 0/21 (0.00%)  0 0/21 (0.00%)  0
*
Indicates events were collected by non-systematic assessment
[1]
Arrhythmia needing a pacemaker fitting
[2]
Resection of a papillary cyst in the bladder. Post study SAE, no relationship to the product.
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
High Polyphenol Milk Chocolate Low Polyphenol Milk Nestle Noir 70 % Chocolate
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/20 (0.00%)      0/21 (0.00%)      0/21 (0.00%)    
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
 
Results Point of Contact
Name/Title: Prof. Stephen Atkin, Principal Investigator
Organization: Medical School, Michael White Diabetes Centre, 220-236, Anlaby Road,
Phone: +44(0)1482 675312
Responsible Party: Nestlé
ClinicalTrials.gov Identifier: NCT01617603     History of Changes
Other Study ID Numbers: 07.52.NRC
First Submitted: June 1, 2012
First Posted: June 12, 2012
Results First Submitted: April 2, 2013
Results First Posted: July 1, 2013
Last Update Posted: July 19, 2013