Healthy Volunteers
Conditions
Brief summary
The objectives of this study are the following: 1) to confirm that the administration of grape juice, resveratrol, and grape seed polyphenol extract results in a similar plasma and urinary metabolic profile in aged humans compared to rats, 2) to confirm that a combined administration of grape juice, resveratrol, and grape seed polyphenol extract result in a similar plasma and urinary metabolic profile in adults with tendencies toward metabolic syndrome compared to non-obese healthy humans, and 3) to identify the anti-inflammatory effects of the combined administration of grape juice, resveratrol, and grape seed polyphenol extract.
Interventions
OTHERGrape
16 oz. of Concord grape juice (8 oz. consumed 2 times per day; total dose of approximately 1.2 g phenolic compounds per day), 250 mg resveratrol provided as a capsule (commercially available supplement; 125 mg consumed 2 times per day), and 1 g grape seed polyphenol extract provided as a capsule (commercially available supplement; 0.5 g consumed 2 times per day).
Sponsors
Janet Novotny
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
No minimum to 59 Years
Healthy volunteers
Yes
Inclusion criteria
\-
Exclusion criteria
* Age \<60 years at beginning of study * Fasting glucose \> 126 mg/dl * Blood pressure \> 160/100 * Fasting total blood cholesterol \> 280 mg/dl * Fasting triglycerides \> 300 mg/dl * Presence of kidney disease, liver disease, gout, hyperthyroidism, untreated or unstable hypothyroidism, certain cancers, gastrointestinal disease, pancreatic disease, other metabolic diseases, or malabsorption syndromes * Presence of type 2 diabetes requiring the use of oral antidiabetic agents or insulin * History of bariatric or certain other surgeries related to weight control * Smokers or other tobacco users (during 6 months prior to the start of the study) * Consumption of more than 3 servings of tea, wine, or grape juice per day * Use of supplements containing grape extracts or products * Use of antibiotics during the intervention or for 3 weeks prior to the intervention period * History of eating disorders, dietary patterns, or supplement use which will interfere with the goal of the intervention * Volunteers who have lost 10% of body weight within the last 4 months * Volunteers who are unable or unwilling to give informed consent or communicate with study staff * Volunteers who 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Plasma polyphenols | 6 hours | Blood will be analyzed for polyphenols and polyphenol metabolites. |
| Urinary polyphenols | 6 hours | Urine will be analyzed for polyphenols and polyphenol metabolites. |
Countries
United States
Outcome results
None listed