Turmeric and Turmeric-containing Tablets and Sebum Production

Study Overview
=================
Brief Summary
-----------------
A noticeably increasing number of patients are asking for naturally based extracts and ingredients as supplementary dermatologic remedies. Patients are seeking natural and cost-effective skin care alternatives in place of prescription medications and procedures. This study will isolate the effects of oral turmeric and assess a combination tablet that includes turmeric on sebum production in healthy subjects.

Detailed Description
-----------------
Turmeric (Curcuma longa) is a spice that has been shown to exhibit anti-inflammatory, antimicrobial, antioxidant, anti-neoplastic properties, and even potential to improve mental illnesses. In western herbalism, Turmeric is primarily used as an anti-inflammatory agent. In India, turmeric is used in Ayurvedic medicine for the treatment of acne. It has been used both internally and externally. Curcumin is a phytochemical derived from turmeric and believed to be one of the key active components of turmeric. Curcumin is reported to have activity as an antibacterial and anti-inflammatory agent and has been used as a paste for skin eruptions and infections. Previous basic science work by Dr. Raja Sivamani's lab has shown that both turmeric and curcumin inhibit lipid synthesis in human sebocytes, the cells responsible for the production of sebum The goal of this study is to evaluate how ingestion of turmeric and tablets that have a combination of herbs including turmeric may modulate sebum production.

Official Title
-----------------
Pilot Study on the Effects of Oral Turmeric and Turmeric-containing Tablets on Sebum Production

Conditions
-----------------
Skin Inflammation

Intervention / Treatment
-----------------
* Dietary Supplement: Turmeric
* Dietary Supplement: Turmeric-containing combination tablet
* Dietary Supplement: Placebo tablets


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age 18 to 50 years of age, and Subject must be able to read and comprehend study procedures and consent forms. Exclusion Criteria: Subject should be generally healthy and have no smoking history in the past one year, and must have no history of diabetes, metabolic syndrome, known cardiovascular disease, malignancy, kidney disease, or chronic steroid use. Subjects who consume more than 6 servings of caffeine per day, such as coffee and energy drinks (example - Red Bull). Subjects with known allergies to herbal ingredients. Subjects with known EKG changes. Those who used topical medications in the past two weeks or systemic antibiotics within one month of starting the study. Subjects who are postmenopausal Those who are pregnant or breastfeeding. Those that are prisoners or cognitively impaired.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Turmeric group<br>2,000 mg turmeric per day - supplied by Banyan® Botanicals ) o Each tablet contains 500 mg of Turmeric (Curcuma longa). Subjects will take 2 tablets twice per day, with a total daily dose of 2,000 mg. | Dietary Supplement: Turmeric<br> <br> |
| Active Comparator: Turmeric-containing combination tablets<br>• 2,000 mg Healthy Skin™ Tablets, contains: Turmeric (Curcuma longa) - 50 mg/tablet Hemidesmus Indicus root (Anantamul) Indian Madder root Neem leaf Gotu Kola leaf Indian TInospora stem Amla fruit Licorice root Phyllanthus Amarus herb Each tablet contains 500mg total of the above herbs. There is 50 mg of Turmeric in each Healthy Skin ™ tablet. Subjects will take 2 tablets twice per day, which will be a total daily dose of 200 mg of Turmeric. This is comparable to the daily amount of Turmeric in many commercially-available Turmeric supplements; therefore, it is valuable to compare this formulation to the turmeric-only tablets. | Dietary Supplement: Turmeric-containing combination tablet<br> <br> |
| Placebo Comparator: Placebo tablets group<br>Supplement appearing similar to those in the turmeric and curcumin groups, supplied by Banyan® Botanicals Ingredients (all organic): Placebo ingredients: Rice hulls concentrate, Maltodextrin, Micro Crystalline Cellulose, Beet Root Powder, Dutch coco powder Dose: subjects in this group will take 2 tablets twice per day | Dietary Supplement: Placebo tablets<br> <br> |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in facial Sebum production at 4 weeks | The investigators will use Sebutapes placed on the forehead to measure facial sebum production for 60 minutes at baseline and after 4 weeks. The tapes will collect the facial sebum produced during that time. | 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in sebum profile, such as inflammatory markers, at 4 weeks |  | 4 weeks |