Trial Outcomes & Findings for Role of Flavanols In Cardiovascular Function in Healthy Aging (NCT NCT01395277)

Last Updated: 2015-08-10

Results Overview

Local heating of the cutaneous vasculature to 42 degree C is commonly used to evoke a maximal skin blood flow response (only at the site of local heating). This response is almost entirely dependent on nitric oxide mediated vasodilation.

Recruitment status

COMPLETED

Study phase

Target enrollment

30 participants

Primary outcome timeframe

prior to (baseline) and 2 hours post beverage consumption

Results posted on

2015-08-10

Participant Flow

Participant milestones

Participant milestones
Measure	High Flavanol First Then Low Flavanol The measurements will be made on all study participants on two separate visits to the laboratory; On the first visit measurements will be made before (baseline) and 2 hrs post consumption of a beverage with "high" flavanol content. On the second study visit measurements will be made before and 2 hrs following consumption of a beverage with "low" flavanol content. During the first visit the high flavanol measures will be performed before and 2 hours following consumption of a beverage containing 1,050 mg of Cocoa Flavanols mixed into 250 ml of distilled water. Measurements will be performed 2 hrs after consumption. During the second visit the low flavanol measures will be performed following consumption of a beverage containing 0 mg of Cocoa Flavanols mixed into 250 ml of distilled water. Measurements will be performed 2 hrs after consumption.	Low Flavanol First Then High Flavanol The measurements will be made on all study participants on two separate visits to the laboratory; On the first visit measurements will be made before (baseline) and 2 hrs post consumption of a beverage with "low" flavanol content. On the second study visit measurements will be made before and 2 hrs following consumption of a beverage with "high" flavanol content. During the first visit the low flavanol measures will be performed before and 2 hours following consumption of a beverage containing 0 mg of Cocoa Flavanols mixed into 250 ml of distilled water. Measurements will be performed 2 hrs after consumption. During the second visit the high flavanol measures will be performed following consumption of a beverage containing 1,050 mg of Cocoa Flavanols mixed into 250 ml of distilled water. Measurements will be performed 2 hrs after consumption.
Overall Study STARTED	15	15
Overall Study COMPLETED	15	15
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Role of Flavanols In Cardiovascular Function in Healthy Aging

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	High Flavanol First Then Low Flavanol n=15 Participants The measurements will be made on all study participants on two separate visits to the laboratory; On the first visit measurements will be made before (baseline) and 2 hrs post consumption of a beverage with "high" flavanol content . On the second study visit measurements will be made before and 2 hrs following consumption of a beverage with "low" flavanol content. During the first visit the high flavanol measures will be performed following consumption of a beverage containing 1,050 mg of Cocoa Flavanols mixed into 250 ml of distilled water. Measurements will be performed 2 hrs after consumption. During the second visit the placebo trial (low flavanol group) will be performed following consumption of a beverage containing 0 mg of Cocoa Flavanols mixed into 250 ml of distilled water. Measurements will be performed 2 hrs after consumption.	Low Flavanol First Then High Flavanol n=15 Participants The measurements will be made on all study participants on two separate visits to the laboratory; On the first visit measurements will be made before (baseline) and 2 hrs post consumption of a beverage with "low" flavanol content. On the second study visit measurements will be made before and 2 hrs following consumption of a beverage with "high" flavanol content. During the first visit the low flavanol measures will be performed following consumption of a beverage containing 0 mg of Cocoa Flavanols mixed into 250 ml of distilled water. Measurements will be performed 2 hrs after consumption. During the second visit the high flavanol measures will be performed following consumption of a beverage containing 1,050 mg of Cocoa Flavanols mixed into 250 ml of distilled water. Measurements will be performed 2 hrs after consumption.	Total n=30 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	8 Participants n=5 Participants	7 Participants n=7 Participants	15 Participants n=5 Participants
Age, Categorical >=65 years	7 Participants n=5 Participants	8 Participants n=7 Participants	15 Participants n=5 Participants
Age, Continuous	68.4 years STANDARD_DEVIATION 2.8 • n=5 Participants	67.5 years STANDARD_DEVIATION 2.9 • n=7 Participants	68.0 years STANDARD_DEVIATION 2.7 • n=5 Participants
Sex: Female, Male Female	7 Participants n=5 Participants	7 Participants n=7 Participants	14 Participants n=5 Participants
Sex: Female, Male Male	8 Participants n=5 Participants	8 Participants n=7 Participants	16 Participants n=5 Participants
Region of Enrollment United States	15 participants n=5 Participants	15 participants n=7 Participants	30 participants n=5 Participants
Mean Blood Pressure	85 mmHg STANDARD_DEVIATION 8 • n=5 Participants	88 mmHg STANDARD_DEVIATION 7 • n=7 Participants	87 mmHg STANDARD_DEVIATION 6 • n=5 Participants

PRIMARY outcome

Timeframe: prior to (baseline) and 2 hours post beverage consumption

Outcome measures

Outcome measures
Measure	High Flavanol n=30 Participants The measurements will be made on all study participants on two separate occasions; 1) before and 2 hours following consumption of a beverage with "high" flavanol content (experimental trial), and 2) before and 2 hours following consumption of a beverage with "low" flavanol content (placebo trial). CocoaVia Dark Chocolate Flavored Drink: The experimental trial (high flavanol group) will be performed following consumption of a beverage containing 1,050 mg of Cocoa Flavanols. This cocoa flavanol powder will be purchased from Mars Incorporated (Hackettstown, New Jersey) and will be mixed into 250 ml of distilled water. The subjects will consume this beverage and measurements will be performed 2 hours after consumption.	Low Flavanol n=30 Participants The measurements will be made on all study participants on two separate occasions; 1) before and 2 hours following consumption of a beverage with "high" flavanol content (experimental trial), and 2) before and 2 hours following consumption of a beverage with "low" flavanol content (placebo trial). Placebo Trial: CocoaVia Dark Chocolate Flavored Drink: The placebo trial (low flavanol content) will be performed following consumption of a beverage containing 75 mg of Cocoa Flavanols. This cocoa flavanol powder will be purchased from Mars Incorporated (Hackettstown, New Jersey) and will be mixed into 250 ml of distilled water. The subjects will consume this beverage and measurements will be performed 2 hours after consumption.
Cutaneous Blood Flow Response to Local Heating of the Skin.	68 percent change in mean skin blood flow Standard Deviation 10.6	70 percent change in mean skin blood flow Standard Deviation 12.3

SECONDARY outcome

Timeframe: Prior to (baseline) and 2 hours following beverage consumption

Assessment of pulse wave velocity in the common carotid artery and the femoral artery provides an index of arterial stiffness.

Outcome measures

Outcome measures
Measure	High Flavanol n=30 Participants The measurements will be made on all study participants on two separate occasions; 1) before and 2 hours following consumption of a beverage with "high" flavanol content (experimental trial), and 2) before and 2 hours following consumption of a beverage with "low" flavanol content (placebo trial). CocoaVia Dark Chocolate Flavored Drink: The experimental trial (high flavanol group) will be performed following consumption of a beverage containing 1,050 mg of Cocoa Flavanols. This cocoa flavanol powder will be purchased from Mars Incorporated (Hackettstown, New Jersey) and will be mixed into 250 ml of distilled water. The subjects will consume this beverage and measurements will be performed 2 hours after consumption.	Low Flavanol n=30 Participants The measurements will be made on all study participants on two separate occasions; 1) before and 2 hours following consumption of a beverage with "high" flavanol content (experimental trial), and 2) before and 2 hours following consumption of a beverage with "low" flavanol content (placebo trial). Placebo Trial: CocoaVia Dark Chocolate Flavored Drink: The placebo trial (low flavanol content) will be performed following consumption of a beverage containing 75 mg of Cocoa Flavanols. This cocoa flavanol powder will be purchased from Mars Incorporated (Hackettstown, New Jersey) and will be mixed into 250 ml of distilled water. The subjects will consume this beverage and measurements will be performed 2 hours after consumption.
Pulse Wave Velocity / Arterial Stiffness	2.5 cm / sec Standard Deviation 0.2	2.7 cm / sec Standard Deviation .30

Adverse Events

High Flavanol First Then Low Flavanol

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Low Flavanol First Then High Flavanol

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. R. Matthew Brothers

University of Texas at Austin

Phone: 512-232-6016

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place