NCT00666250

Brief Summary

An antioxidant dietary supplement made from cocoa powder, and extracts of acai, grape and blueberry will be tested for effects on blood sugar, blood pressure, cholesterol and related parameters in human subjects.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for not_applicable hypertension

Timeline
Completed

Started Jan 2006

Typical duration for not_applicable hypertension

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2006

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2008

Completed
21 days until next milestone

First Submitted

Initial submission to the registry

April 22, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 24, 2008

Completed
Last Updated

February 8, 2016

Status Verified

April 1, 2008

Enrollment Period

2.2 years

First QC Date

April 22, 2008

Last Update Submit

February 4, 2016

Conditions

HypertensionDyslipidemiaHyperglycemia

Keywords

blood pressuredyslipidemiahyperglycemia

Outcome Measures

Primary Outcomes (1)

  • Blood pressure

    4 weeks

Secondary Outcomes (4)

  • Plasma Lipids

    4 weeks

  • Arterial Compliance

    4 weeks

  • Fasting and post-challenge glucose and insulin

    4 weeks

  • urine microalbumin/creatinine ratio

    4 weeks

Study Arms (3)

Baseline

NO INTERVENTION

Baseline values off chocolate supplement

Low Dose

EXPERIMENTAL

Low dose of dietary supplement 30 ml tid (Activ Xocai Drink)

Dietary Supplement: Xocai Activ drink

High-dose

EXPERIMENTAL

High dose of dietary supplement 90 ml tid (Xocai Activ drink)

Dietary Supplement: Xocai Activ drink

Interventions

Xocai Activ drinkDIETARY_SUPPLEMENT

proprietary blend of cocoa powder and extracts of acai, grape and blueberry

Also known as: Xocai Activ drink;, cocoa powder,, acai extract,, grape extract,, blueberry extract
High-doseLow Dose

Eligibility Criteria

Age18 Years - 95 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • healthy adult not taking cocoa supplements

You may not qualify if:

  • diabetes mellitus

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cardiovascular Genetics, University of Utah

Salt Lake City, Utah, 84108, United States

Location

Related Links

MeSH Terms

Conditions

HypertensionDyslipidemiasHyperglycemia

Interventions

Chocolatewhole grape extractblueberry extract

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular DiseasesLipid Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesGlucose Metabolism Disorders

Intervention Hierarchy (Ancestors)

FoodDiet, Food, and NutritionPhysiological PhenomenaFood and Beverages

Study Officials

  • Eliot Brinton, MD

    University of Utah

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
PREVENTION
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 22, 2008

First Posted

April 24, 2008

Study Start

January 1, 2006

Primary Completion

April 1, 2008

Study Completion

April 1, 2008

Last Updated

February 8, 2016

Record last verified: 2008-04

Locations

US(1)