Trial Outcomes & Findings for Efficacy of Polyphenols From Milk and Dark Chocolate (NCT NCT00513344)

Last Updated: 2013-08-14

Results Overview

Value of RHI at 2 hours minus value at baseline. RHI reflects the endothelial function of a vessel at the distal phalanx of a finger, i.e. the capacity of the vessel to dilate after an ischemia. RHI is the increase of blood flow following the occlusion of the brachial artery during 5 minutes by the inflation of an armcuff. RHI was measured by peripheral arterial tonometry using a fingerprobe connected to an EndoPat analyser.

Recruitment status

COMPLETED

Study phase

Target enrollment

6 participants

Primary outcome timeframe

Baseline and 2 hours

Results posted on

2013-08-14

Participant Flow

5 healthy subjects, 2 females and 3 males, were recruited within the staff of the Nestlé Research Center in June-July 2008.

From 3 days before the first test session no foods containing epicatechin or catechin or procyanidins should be ingested. The subjects received a single dose of the 3 products in a randomised order with a minimum of 3 days washout in between (crossover design). The duration of the study was a minimum of 15 days.

Participant milestones

Participant milestones
Measure	Each Subject Tested the Three Products Randomly Following Before the 1st intervention, no food with polyphenols was admitted Each subject was administered the three products randomly(one product per one-day intervention) according to the six possible sequencies: * Either dark chocolate first, then milk chocolate then control * or dark chocolate first, then control, then milk chocolate * or control first, then dark chocolate, then milk chocolate * or Control first, then milk chocolate, then dark chocolate * or Milk chocolate first, then control, then dark chocolate * or milk chocolate first, then dark chocolate, then control r dark chocolate was given once in the morning (1 day) Products were administered in the morning of the testing day. The testing days (interventions) were separated by a three-day wash-out period.
Diet Restriction (3 Days) STARTED	5
Diet Restriction (3 Days) COMPLETED	5
Diet Restriction (3 Days) NOT COMPLETED	0
1st Intervention 1 Day STARTED	5
1st Intervention 1 Day COMPLETED	5
1st Intervention 1 Day NOT COMPLETED	0
Washout Period 3 Days STARTED	5
Washout Period 3 Days COMPLETED	5
Washout Period 3 Days NOT COMPLETED	0
2nd Intervention 1 Day STARTED	5
2nd Intervention 1 Day COMPLETED	5
2nd Intervention 1 Day NOT COMPLETED	0
3rd Intervention 1 Day STARTED	5
3rd Intervention 1 Day COMPLETED	5
3rd Intervention 1 Day NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Efficacy of Polyphenols From Milk and Dark Chocolate

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Entire Study Population n=5 Participants Includes groups randomized to receive control first, milk chocolate first, and dark chocolate first
Age Continuous	34 years STANDARD_DEVIATION 7 • n=93 Participants
Age, Customized <= 28 years	0 participants n=93 Participants
Age, Customized between 28 and 42 years	5 participants n=93 Participants
Age, Customized >= 42 years	0 participants n=93 Participants
Sex: Female, Male Female	2 Participants n=93 Participants
Sex: Female, Male Male	3 Participants n=93 Participants
Region of Enrollment Switzerland	5 participants n=93 Participants

PRIMARY outcome

Timeframe: Baseline and 2 hours

Population: Taking into account the fact that there is no background data and that we need to have accurate evaluation of central tendency and dispersion, a minimum of five complete subjects are needed. Data from all randomized subjects were considered in the intention to treat model (for the primary outcome).

Outcome measures

Outcome measures
Measure	Control Chocolate With no Polyphenols n=5 Participants cocoa-free chocolate Control (polyphenol-free)	Milk Chocolate Containing Polyphenols n=5 Participants Bespoke milk chocolate Milk Chocolate : 1 portion	Dark Chocolate Containing Polyphenols n=5 Participants dark chocolate Dark Chocolate : 1 portion
Change in Reactive Hyperemia Index (RHI) From Baseline (20 Min Before Product Intake) to 2 Hours Following Product Intake	2.12 percentage of the pulse wave amplitude Standard Error 0.52	2.30 percentage of the pulse wave amplitude Standard Error 0.71	2.26 percentage of the pulse wave amplitude Standard Error 0.65

SECONDARY outcome

Timeframe: baseline and 2 hours

Value of arterial stiffness at 2 hours minus value at baseline. Arterial stiffness is also automatically calculated by peripheral arterial tonometry which consists in measuring the peripheral vessel endothelial response to an ischemia provoked by a 5-min occlusion of the humeral artery using an armcuff. An increase in arterial stiffness means an increase in the resistance of the vessel wall which reflects an impaired endothelial response to ischemia.

Outcome measures

Outcome measures
Measure	Control Chocolate With no Polyphenols n=5 Participants cocoa-free chocolate Control (polyphenol-free)	Milk Chocolate Containing Polyphenols n=5 Participants Bespoke milk chocolate Milk Chocolate : 1 portion	Dark Chocolate Containing Polyphenols n=5 Participants dark chocolate Dark Chocolate : 1 portion
Change in Arterial Stiffness From Baseline (20 Min Before Product Intake) to Two Hours Following Product Intake	-13.23 percentage of baseline Standard Deviation 11.16	1.23 percentage of baseline Standard Deviation 12.87	-9.49 percentage of baseline Standard Deviation 15.03

Adverse Events

Dark Chocolate

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Milk Chocolate

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Control

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr Maurice Beaumont, Principal Investigator

Clinical Development Unit / Metabolic Unit

Phone: +41217858054

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place