Effects of Phytonutrients on Vascular Health and Skin in Obese Males

The proposed investigation has two major objectives: 1. to determine the clinical efficacy of
pomegranate juice to reduce skin aging by assessing UV-induced change and skin biological
characteristics of elasticity, sebum, hydration/moisture and systemic inflammation and 2. To
determine the impact of pomegranate polyphenols on the metabolic response to a high fat meal
by postprandial flow-mediated dilation and plasma nitric oxide. The investigators propose to
achieve the following specific aims in a randomized, two arm, parallel intervention of
pomegranate juice or placebo for 12 weeks in obese men.

Inclusion Criteria:

- 18 - 65 years old males (inclusive)

- BMI range from 30 to 45 (inclusive)

- Non-smokers

- Fitzpatrick Skin type II-IV

- Willing to maintain normal activity and eating patterns for the duration of the study

- Willing to maintain their normal diet for the duration of the study but avoid
pomegranate products and ellagitannin rich foods.

Exclusion Criteria:

- Any subject with a history of diabetes mellitus on medications, or other serious
medical condition, such as chronic hepatic or renal disease, bleeding disorder,
congestive heart disease, chronic diarrhea disorders, myocardial infarction, coronary
artery bypass graft, angioplasty within 6 months prior to screening, current diagnosis
of uncontrolled hypertension (defined as systolic BP>160mmHg, diastolic BP>95mmHg),
active or chronic gastrointestinal disorders, bulimia, anorexia, or endocrine diseases
(except thyroid disease requiring medication) as indicated by medical history or
routine physical examination.

- Known cardiovascular disease, as defined by a self-reported history or medical record
documentation of any of the following: myocardial infarction, angina pectoris, prior
revascularization (coronary artery bypass graft, percutaneous coronary intervention),
peripheral vascular disease, arrhythmias, congestive heart failure, congenital heart
disease, cerebrovascular disease (stroke, transient ischemic attack).

- History of known vascular disorder or autoimmune processes including Crohn's disease,
ulcerative colitis, severe psoriasis, rheumatoid arthritis, and cryoglobulinemia that
may affect vascular studies.

- History of skin cancer (melanoma or non-melanoma), xeroderma, pigmetosum, systemic
lupus erythematosus, or dermatomyositis.

- Any subject who is taking photosensitizing medications, i.e. Ibuprofen, Naprosyn,
furosemide, hydrochlorothiazide, isotretinoin statins, and phenothizaones.

- Any subject who is taking vasoactive medications (such as nitrates, calcium channel
blockers, and beta-blockers)

- Any subject with a screening laboratory value outside of the laboratory normal range
that is considered clinically significant for study participation by the investigator.

- Abnormal liver function (AST and ALT > 2 x upper limit)

- Currently taking steroidal drugs

- Cancer treated within the past two years

- Participation in a therapeutic research study within 30 days of baseline

- Use of antibiotics within one month

- Allergy or sensitivity to pomegranate products

- Follows a vegetarian, vegan or beef-free diet