The Potential for Pomegranate Juice to Ameliorate Endothe... | NCT01748617

NCT01748617

Protocol Section

Identification Module

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Status Module

Oversight Module

Description Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Pomegranate Juice	Experimental	Acute ingestion of pomegranate juice with high fat meal.	Other: Controlled diet
Control	Placebo Comparator	Acute ingestion of juice-free sweetened beverage with high fat meal.	Other: Controlled diet

Name	Type	Description	Arm Group Labels	Other Names
Controlled diet	Other	1 week of controlled diet	Control Pomegranate Juice

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Change in endothelial function	After a consuming controlled diet for 1 week, subjects will report in the morning after a 12 hour fast. Upon arrival , subjects' endothelial function will be assessed by measuring endothelium-dependent flow mediated dilation of the peripheral bed (EndoPAT, Itamar Medical, Israel). For this test, subjects will rest in the supine position with a brachial blood pressure cuff on one arm and a finger tip probe on each of two fingers (one on the left hand, one on the right hand). After 5 minutes of rest, the blood pressure cuff will be inflated and remain inflated for 5 minutes. Then the cuff pressure will be released and the subject will remain resting for 5 additional minutes. This test will be repeated 3 hours after the test meal.	0 hour and 3 hour

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Men and women between the ages of 25-70 years
Body mass index (BMI) ≥ 19 and ≤ 38
Willingness and ability to make scheduled appointments at clinical site as required by study protocol

Exclusion Criteria:

Known (self-reported) allergy or adverse reaction to study foods
Presence of kidney disease, liver disease, gout, untreated or unstable hyperthyroidism, untreated or unstable hypothyroidism, certain cancers, gastrointestinal disease, pancreatic disease, other metabolic diseases, or malabsorption syndromes
Type 2 diabetes requiring the use of oral antidiabetic agents or insulin
Fasting triglycerides > 300 mg/dL
Fasting glucose > 126 mg/dL
Use of cholesterol lowering medication
Blood pressure > 180/100 or hypertension treated with calcium channel blockers, direct acting vasodilators, or beta blockers
Fingernails longer than 0.25 inch beyond the finger tip, or unwillingness to cut fingernails to this length during endothelial function testing
History of bariatric or certain other surgeries related to weight control
History of major surgery within 3 months of enrollment
Smokers or other tobacco users (during 6 months prior to the start of the study)
Antibiotic use during the intervention or for 3 months prior to the intervention period
History of eating disorders or other dietary patterns which are not consistent with the dietary intervention (e.g., vegetarians, very low fat diets, high protein diets)
Volunteers who have lost 10% of body weight within the last 6 months
Unable or unwilling to give informed consent or communicate with study staff
Self-report of alcohol or substance abuse within the past 12 months and/or current acute treatment or rehabilitation program for these problems (long-term participation in Alcoholics Anonymous is not an exclusion)
Other medical, psychiatric, or behavioral factors that in the judgment of the Principal Investigator may interfere with study participation or the ability to follow the intervention protocol