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

NCT ID: NCT03309982

Last Updated: 2018-04-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 27 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-10-16
• Study Completion Date: 2018-03-27

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 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.

Conditions

Anthocyanins

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: OTHER
• Blinding Strategy: TRIPLE

Study Groups

Plant polyphenol blend

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.

Group Type: EXPERIMENTAL

Plant polyphenol blend

Intervention Type: DIETARY_SUPPLEMENT

A powder product that will be mixed into a drink and consumed immediately prior to eating a high-fat meal

Placebo

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).

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: OTHER

A powder product that will be mixed into a drink and consumed immediately prior to eating a high-fat meal

Interventions

Plant polyphenol blend

A powder product that will be mixed into a drink and consumed immediately prior to eating a high-fat meal

Intervention Type: DIETARY_SUPPLEMENT

Placebo

A powder product that will be mixed into a drink and consumed immediately prior to eating a high-fat meal

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 35 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Pharmanex

INDUSTRY

Sponsor Role: lead

Responsible Party

Patricia Oteiza, PhD

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Patricia Oteiza, PhD

Role: PRINCIPAL_INVESTIGATOR

UC Davis

Locations

UC Davis Nutrition Department

Davis, California, United States

Countries

United States

Other Identifiers

17-PHX-0002

Identifier Type: -

Identifier Source: org_study_id