Metabolic Syndrome
Conditions
Brief summary
The purpose of this study is to determine whether taking grape seed extract prior to eating a high fat meal will reduce the inflammatory response in people with the metabolic syndrome.
Detailed description
The purpose of this study is to determine whether taking grape seed extract prior to eating a high fat meal will reduce the inflammatory response in people with the metabolic syndrome. If this extract is shown to mitigate the inflammatory response induced by a high fat meal, it could potentially aid in postponing of the diagnosis of diabetes or other chronic diseases associated with high levels of inflammation.
Interventions
DIETARY_SUPPLEMENTPlacebo
Sugar pill containing maltodextrin.
DIETARY_SUPPLEMENTGrape seed extract
Meganatural Gold® contains 300mg of grape seed extract.
Sponsors
University of California, Davis
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
PREVENTION
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
The metabolic syndrome will be diagnosed on the basis of having a combination of any 3 of the following factors: 1. Waist circumference of ≥ 40 inches (men) or ≥ 35 inches (women) 2. Elevated triglycerides ≥150mg/dl 3. HDL cholesterol of \< 40mg/dl (men) or \< 50mg/dl (women) 4. Elevated blood pressure of ≥ 130/85mmHg 5. Fasting glucose of \> 100mg/dL
Exclusion criteria
* Smokers * Female subjects who are pregnant or lactating * Subjects taking any medications that would interfere with outcomes of the study i.e. lipid lowering medications, anti-inflammatory drugs (i.e. ibuprofen), dietary supplements * Subjects with any known allergy or intolerance to foods involved in the study (cantaloupe, egg, dairy, wheat, grape seed extract) * Subjects who are actively trying to lose weight * Subjects with unusual dietary habits (i.e. pica, anorexia nervosa, extreme food restriction, binging and/or purging disorders) * Subjects who are addicted to drugs or alcohol or who are \<1 year recovery program * Subjects who present with significant psychiatric or neurological disturbances as determined by the primary investigator (i.e. uncontrolled bipolar disorder) * Subjects with documented atherosclerotic disease, inflammatory disease, diabetes mellitus, uncontrolled hypertension (≥ 140/90mmHg), liver and kidney disease as identified by routine blood tests (chemistry panels). These subjects will be referred to their primary care doctor for further care.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Modification of the postprandial inflammatory response. | 7 hours | Analysis of inflammatory markers known to increase following a meal high in fat (\ 40% kcal from fat). Markers to be analyzed will include the following: 1. Serum lipids 2. Oxidized LDL 3. Hs-CRP 4. TNFα 5. IL1 6. IL6 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Metabolic response to a high fat meal. | 7 hours | Assay for the insulin and glucose response generated from consumming a high fat meal (\ 40% of kcal from fat). |
Countries
United States
Outcome results
None listed