Study Assessing the Effect of Chocolate Consumption in Subjects With A History of Acne Vulgaris

Summary

The investigators conducted a recent pilot study and found a strong positive correlation between the consumption of 100% chocolate and acne exacerbation. However, this study had limitations including the lack of placebo and the small sample size. Although studies have been conducted assessing chocolate's effect on acne, no study has been done evaluating this effect using chocolate with 100% cocoa content in a double blind placebo controlled fashion. This study will analyze the difference in the number and type of acneiform lesions per subject at the different time points (Day 4 and Day 7) compared to baseline in order to increase the validity of the investigators results. In addition, the investigators will use unsweetened cocoa powder,12 rather than chocolate candy, which contains higher quantities of additive ingredients such as sugar and milk to avoid interference with the results and the possibility to establish or not an association between the unsweetened cocoa and an effect on acne.

Conditions

• Acne

Interventions

DIETARY_SUPPLEMENT

100% cocoa powder

A single-center, prospective, double blind, placebo controlled study will be conducted in which male subjects with very mild acne swallow capsules filled with either unsweetened 100% cocoa (Ghirardelli), hydrolyzed gelatin powder (Gelita), or a combination of the two, at baseline. The study team will fill the capsules with either 6 oz. of hydrolyzed gelatin, 6 oz. cocoa powder (Ghirardelli ©), or a 6 oz. combination of cocoa powder (Ghirardelli ©) and hydrolyzed gelatin, totaling 6oz using a capsule encapsulation sheet (holding 60 capsules that need to be filled each time). All subjects will ingest the same number of total capsules. Evaluations will be performed using clinical assessments 4 days and 7 days after baseline evaluations (+/- 1 days).

DIETARY_SUPPLEMENT

gelatin (Gelita)

A single-center, prospective, double blind, placebo controlled study will be conducted in which male subjects with very mild acne swallow capsules filled with either unsweetened 100% cocoa (Ghirardelli), hydrolyzed gelatin powder (Gelita), or a combination of the two, at baseline. The study team will fill the capsules with either 6 oz. of hydrolyzed gelatin, 6 oz. cocoa powder (Ghirardelli ©), or a 6 oz. combination of cocoa powder (Ghirardelli ©) and hydrolyzed gelatin, totaling 6oz using a capsule encapsulation sheet (holding 60 capsules that need to be filled each time). All subjects will ingest the same number of total capsules. Evaluations will be performed using clinical assessments 4 days and 7 days after baseline evaluations (+/- 1 days).

Sponsors & Collaborators

• University of Miami

  lead OTHER

Principal Investigators

• Samantha Block, B.S. · University of Miami

• Brian Berman, M.D., Ph.D. · University of Miami

• Caroline Caperton, M.D., M.S.P.H. · University of Miami

• Whitney Valins, B.S. · University of Miami

Study Design

Allocation

RANDOMIZED

Purpose

DIAGNOSTIC

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

35 Years

Sex

MALE

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2010-09-30

Primary Completion

2012-07-31

Completion

2012-07-31

Countries

• United States

Study Locations