Status:
COMPLETED
Intestinal Inflammatory and Metabolic Responses to a High Fat Meal and Plant Polyphenol Blend
Lead Sponsor:
Pharmanex
Conditions:
Anthocyanins
Eligibility:
All Genders
18-35 years
Phase:
NA
Brief Summary
This study will investigate the beneficial effects of supplementation with a plant polyphenol blend rich in anthocyanins on parameters of inflammation and metabolic responses following a challenge wit...
Eligibility Criteria
Inclusion
- Healthy subjects who, in the opinion of the investigator, are free of any medical conditions that might affect study measures.
- Males and females
- Age between 18 - 35 years inclusive
- Subjects with BMI of 22 - 29.9 kg/m2
- Subjects who agree to discontinue the use of pre- and probiotic and/or polyphenol supplements from 4 weeks prior to the first and through the last study visit
- Subjects who agree to discontinue foods containing anthocyanins (such as blueberries, blackberries, bilberries, cherries, grapes, grape juice, pomegranate, raspberries, huckleberries, strawberries, and red wine) for at least 1 week prior to each visit.
- Subjects with no known allergies to study product or components (bilberries, black currants, rice)
- Subjects willing to completely consume high-fat meal and assigned study product
- Subjects willing to consume a similar, low fat/low flavonoid \\dinner the evening before each high-fat meal visit
- Subjects have given voluntary, written, informed consent to participate in the study
Exclusion
- Age \< 18 or \> 35 years
- BMI \< 22 or \> 29.9 kg/m2
- Vegetarian or other dietary restrictions that would not allow the subject to consume the highfat meal
- Regularly participates in endurance exercise activities (e.g. marathon running, triathlons)
- Uncontrolled hypertension defined as diastolic blood pressure ≥ 95 mmHg or systolic blood pressure ≥ 160 mmHg
- Screening serum triglycerides \> 150 mg/dL
- Screening fasting blood glucose \< 50 mg/dL or \> 100 mg/dL
- Current smoker or use of tobacco products within the past year
- Individuals who binge drink (alcohol intake ≥ 5 alcoholic drinks for males or ≥4 alcoholic drinks for females on the same occasion (i.e., at the same time or within a couple of hours of each other)
- Substance abuse or dependence within the prior 60 days.
- Daily use of anti-inflammatory medications including NSAIDs and aspirin in the last 4 weeks
- Use of laxative medications or other products that promote colon cleansing in the last 4 weeks
- History of restricted diets or use of herbal supplements or medications that interfere with insulin metabolism in the last 4 weeks
- History of stroke, hepatic, kidney, thyroid disease or cancer
- History of immune related disorders or Raynaud's disease
- Current clinically significant depression, anxiety or other psychiatric condition
- History of malabsorption or GI tract disorders
- History of GI surgeries (i.e. lapband, gastric bypass, etc.)
- Diarrhea or oral antibiotic intake within the last 4 weeks
- Weight change (\> 5%) in the last 8 weeks
- Subject with known history of eating disorders such as bulimia, anorexia, or muscle dysmorphia
- Allergy or sensitivity to the study product or components of the high-fat meal
- Any other condition which in the Investigator's opinion may adversely affect the subject's ability to complete the study or its measures or which may pose significant risk to the subject
Key Trial Info
Start Date :
October 16 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 27 2018
Estimated Enrollment :
27 Patients enrolled
Trial Details
Trial ID
NCT03309982
Start Date
October 16 2017
End Date
March 27 2018
Last Update
April 20 2018
Active Locations (1)
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1
UC Davis Nutrition Department
Davis, California, United States, 95616