Intestinal Inflammatory and Metabolic Responses to a High Fat Meal and Plant Polyphenol Blend

Pharmanex

Status: Completed

Conditions: Anthocyanins

Treatments: Dietary Supplement: Plant polyphenol blend; Other: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT03309982

17-PHX-0002

Details and patient eligibility

About

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 with a high-fat (HF) meal.

The investigators will use a randomized crossover study to investigate the effects of: 1) placebo (control); 2) plant polyphenol blend rich in anthocyanins; on systemic inflammatory markers (endotoxemia, cytokines, NF-κB), glucose and lipid metabolic responses following consumption of a high-fat (HF) meal in healthy subjects. The high-fat meal (320 g) consists of English muffin bread, sausage, egg and cheese, obtained from US market and completed with palm fat. The total energy content of the high-fat meal is 1,026 Kcal with 70.5 g of fat (29.8 g of saturated fat), 270 mg of cholesterol, 65 g carbohydrate, 5.2 g sugar, and 33 g protein with a total of 62% energy originated from fat, 25% from carbohydrates and 13% from protein. The high-fat meal will be standard and it will not be adjusted for large and small participants.

Enrollment: 27 patients

Sex: All

Ages: 18 to 35 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. Healthy subjects who, in the opinion of the investigator, are free of any medical conditions that might affect study measures.
2. Males and females
3. Age between 18 - 35 years inclusive
4. Subjects with BMI of 22 - 29.9 kg/m2
5. 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
6. 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.
7. Subjects with no known allergies to study product or components (bilberries, black currants, rice)
8. Subjects willing to completely consume high-fat meal and assigned study product
9. Subjects willing to consume a similar, low fat/low flavonoid \dinner the evening before each high-fat meal visit
10. Subjects have given voluntary, written, informed consent to participate in the study

Exclusion criteria

1. Age < 18 or > 35 years
2. BMI < 22 or > 29.9 kg/m2
3. Vegetarian or other dietary restrictions that would not allow the subject to consume the highfat meal
4. Regularly participates in endurance exercise activities (e.g. marathon running, triathlons)
5. Uncontrolled hypertension defined as diastolic blood pressure ≥ 95 mmHg or systolic blood pressure ≥ 160 mmHg
6. Screening serum triglycerides > 150 mg/dL
7. Screening fasting blood glucose < 50 mg/dL or > 100 mg/dL
8. Current smoker or use of tobacco products within the past year
9. 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)
10. Substance abuse or dependence within the prior 60 days.
11. Daily use of anti-inflammatory medications including NSAIDs and aspirin in the last 4 weeks
12. Use of laxative medications or other products that promote colon cleansing in the last 4 weeks
13. History of restricted diets or use of herbal supplements or medications that interfere with insulin metabolism in the last 4 weeks
14. History of stroke, hepatic, kidney, thyroid disease or cancer
15. History of immune related disorders or Raynaud's disease
16. Current clinically significant depression, anxiety or other psychiatric condition
17. History of malabsorption or GI tract disorders
18. History of GI surgeries (i.e. lapband, gastric bypass, etc.)
19. Diarrhea or oral antibiotic intake within the last 4 weeks
20. Weight change (> 5%) in the last 8 weeks
21. Subject with known history of eating disorders such as bulimia, anorexia, or muscle dysmorphia
22. Allergy or sensitivity to the study product or components of the high-fat meal
23. 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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Triple Blind

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27 participants in 2 patient groups, including a placebo group

Plant polyphenol blend

Experimental group

Description:

The study product (4 g) consists of 3 g of a mix a maltodextrins, and 1 g of anthocyanin-rich plant polyphenol blend containing: 1) 100 mg bilberry extract; 2) 300 mg black currant extract; and 3) 600 mg black rice extract.

Treatment:

Dietary Supplement: Plant polyphenol blend

Placebo

Placebo Comparator group

Description:

The placebo (4 g) consists of a mix of maltodextrins (3.85 g) and Red Dye No. 40 (0.125 g) and Blue Dye No. 1 (0.025 g).

Treatment:

Other: Placebo