Food Matrix Effect on Flavanol Absorption, Metabolism and Excretion: Methylxanthines
Status: | Active, not recruiting |
---|---|
Conditions: | Healthy Studies |
Therapuetic Areas: | Other |
Healthy: | No |
Age Range: | 25 - 60 |
Updated: | 5/30/2018 |
Start Date: | February 16, 2017 |
End Date: | December 23, 2018 |
Dietary intervention study in healthy young adult males to evaluate concentration of flavanol
metabolites in plasma and urine after single acute intakes of methylxanthines.
metabolites in plasma and urine after single acute intakes of methylxanthines.
Flavonoids, including the sub groups of Flavanols (F) are plant-derived compounds commonly
present in the human diet. Examples of F-containing foods and beverages are apples,
chocolate, tea, wine, berries, pomegranate and nuts. The consumption of F-containing foods
and beverages has been associated with improvements in cardiovascular health. In this
context, there exists a great interest in describing the absorption, metabolism and excretion
of F in humans, as it is thought that F-derived metabolites present in circulation are the
mediators of F-beneficial effects in humans. Recently, the investigators described a series
of F-derived metabolites in circulation that are present after the consumption of a single
acute intake amount of F in humans as well as F-metabolites derived from the metabolic
activity of the gut microbiome. A key question, however, is if the metabolites the
investigators observed after a single acute feeding are the same as those that occur in
individuals who consume F-rich diets on a regular basis. Studies investigating the metabolism
of numerous other xenobiotics have shown that the profile of metabolites can greatly vary
over time, as well as with the amount of the xenobiotic ingested. In this context, the
investigators submit it is important to assess whether or not there are food matrix-dependent
effects on the levels and profile of F-derived metabolites in humans. The investigators
suggest the information that will be obtained from the outlined work will be particularly
timely given ongoing discussion concerning the possible generation of dietary recommendations
for F-rich foods and increasing interest in the putative health effects of F intake in
humans.
present in the human diet. Examples of F-containing foods and beverages are apples,
chocolate, tea, wine, berries, pomegranate and nuts. The consumption of F-containing foods
and beverages has been associated with improvements in cardiovascular health. In this
context, there exists a great interest in describing the absorption, metabolism and excretion
of F in humans, as it is thought that F-derived metabolites present in circulation are the
mediators of F-beneficial effects in humans. Recently, the investigators described a series
of F-derived metabolites in circulation that are present after the consumption of a single
acute intake amount of F in humans as well as F-metabolites derived from the metabolic
activity of the gut microbiome. A key question, however, is if the metabolites the
investigators observed after a single acute feeding are the same as those that occur in
individuals who consume F-rich diets on a regular basis. Studies investigating the metabolism
of numerous other xenobiotics have shown that the profile of metabolites can greatly vary
over time, as well as with the amount of the xenobiotic ingested. In this context, the
investigators submit it is important to assess whether or not there are food matrix-dependent
effects on the levels and profile of F-derived metabolites in humans. The investigators
suggest the information that will be obtained from the outlined work will be particularly
timely given ongoing discussion concerning the possible generation of dietary recommendations
for F-rich foods and increasing interest in the putative health effects of F intake in
humans.
Inclusion Criteria:
- No prescription medications
- BMI 18.5 - 29.9 kg/m2
- Weight ≥ 110 pounds
- previously consumed cocoa, peanut, parsley, celery and chamomile products with no
adverse reactions
Exclusion Criteria:
- Adults unable to consent
- Prisoners
- Non-English speaking*
- BMI ≥ 30 kg/m2
- Performing vigorous physical activity (i.e. more than 6 MET; metabolic equivalence of
task as defined by CDC and ACSM guidelines
(http://www.cdc.gov/physicalactivity/everyone/glossary/index.html#vig-intensity; and
http://www.cdc.gov/nccdphp/dnpa/physical/pdf/PA_Intensity_table_2_1.pdf ) for more
than 3 days a week.
- Dietary allergies including those to nuts, cocoa and chocolate products, parsley,
celery and chamomile.
- Active avoidance of coffee and caffeinated soft drinks
- Under current medical supervision
- A history of cardiovascular disease, stroke, renal, hepatic, or thyroid disease
- History of clinically significant depression, anxiety or other psychiatric condition
- History of Raynaud's disease
- History of difficult blood draws
- Indications of substance or alcohol abuse within the last 3 years
- Current use of herbal, plant or botanical supplements (multi-vitamin/mineral
supplements are allowed)
- Blood Pressure > 140/90 mm Hg
- GI tract disorders, previous GI surgery (except appendectomy)
- Self-reported malabsorption (e.g. difficulty digesting or absorbing nutrients from
food, potentially leading to bloating, cramping or gas)
- Diarrhea within the last 3 months, or antibiotic intake within the last 3 months
- Vegetarian, Vegan, food faddists, individuals using non-traditional diets, on a weight
loss diet or individuals following diets with significant deviations from the average
diet
- Metabolic panel and cholesterol results or complete blood counts that are outside of
the normal reference range and are considered clinically relevant by the study
physician
- Cold, flu, or upper respiratory condition at screening
- Currently participating in a clinical or dietary intervention study
We found this trial at
2
sites
1 Shields Ave
Davis, California 95616
Davis, California 95616
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