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Completed

NCT Number: NCT03309982

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

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.

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Key information

Conditions

Age range

18 year–35 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

UC Davis Nutrition Department

Davis, California, 95616, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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 criteria

  • 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

Treatment and study plan

Plant polyphenol blend

Dietary Supplement

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

Placebo

Other

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

Primary outcomes

  1. Change from baseline in plasma endotoxin at 0.5 hr, 1 hr, 2hrs, 3hrs, and 5hrs post high-fat meal consumption

    Time frame: Baseline, 0.5 hr, 1 hr, 2hrs, 3hrs, and 5hrs post high-fat meal consumption

    blood sample collected by venipuncture to measure endotoxin in plasma

Secondary outcomes

  1. Change from baseline in plasma IL-6 at 0.5 hr, 1 hr, 2hrs, 3hrs, and 5hrs post high-fat meal consumption

    Time frame: Baseline, 0.5 hr, 1 hr, 2hrs, 3hrs, and 5hrs post high-fat meal consumption

    blood sample collected by venipuncture to measure IL-6 in plasma

  2. Change from baseline in plasma insulin at 0.5 hr, 1 hr, 2hrs, 3hrs, and 5hrs post high-fat meal consumption

    Time frame: Baseline, 0.5 hr, 1 hr, 2hrs, 3hrs, and 5hrs post high-fat meal consumption

    blood sample collected by venipuncture to measure insulin in plasma

  3. Change from baseline in plasma GLP-1 at 0.5 hr, 1 hr, 2hrs, 3hrs, and 5hrs post high-fat meal consumption

    Time frame: Baseline, 0.5 hr, 1 hr, 2hrs, 3hrs, and 5hrs post high-fat meal consumption

    blood sample collected by venipuncture to measure GLP-1 in plasma

  4. Change from baseline in plasma GLP-2 at 0.5 hr, 1 hr, 2hrs, 3hrs, and 5hrs post high-fat meal consumption

    Time frame: Baseline, 0.5 hr, 1 hr, 2hrs, 3hrs, and 5hrs post high-fat meal consumption

    blood sample collected by venipuncture to measure GLP-2 in plasma

  5. Change from baseline in plasma GIP at 0.5 hr, 1 hr, 2hrs, 3hrs, and 5hrs post high-fat meal consumption

    Time frame: Baseline, 0.5 hr, 1 hr, 2hrs, 3hrs, and 5hrs post high-fat meal consumption

    blood sample collected by venipuncture to measure GIP in plasma

  6. Change from baseline in plasma adiponectin at 0.5 hr, 1 hr, 2hrs, 3hrs, and 5hrs post high-fat meal consumption

    Time frame: Baseline, 0.5 hr, 1 hr, 2hrs, 3hrs, and 5hrs post high-fat meal consumption

    blood sample collected by venipuncture to measure adiponectin in plasma

  7. Change from baseline in plasma leptin at 0.5 hr, 1 hr, 2hrs, 3hrs, and 5hrs post high-fat meal consumption

    Time frame: Baseline, 0.5 hr, 1 hr, 2hrs, 3hrs, and 5hrs post high-fat meal consumption

    blood sample collected by venipuncture to measure leptin in plasma

  8. Change from baseline in plasma ghrelin at 0.5 hr, 1 hr, 2hrs, 3hrs, and 5hrs post high-fat meal consumption

    Time frame: Baseline, 0.5 hr, 1 hr, 2hrs, 3hrs, and 5hrs post high-fat meal consumption

    blood sample collected by venipuncture to measure ghrelin in plasma

  9. Change from baseline in plasma triglycerides at 0.5 hr, 1 hr, 2hrs, 3hrs, and 5hrs post high-fat meal consumption

    Time frame: Baseline, 0.5 hr, 1 hr, 2hrs, 3hrs, and 5hrs post high-fat meal consumption

    blood sample collected by venipuncture to measure triglycerides in plasma

  10. Change from baseline in plasma total cholesterol at 0.5 hr, 1 hr, 2hrs, 3hrs, and 5hrs post high-fat meal consumption

    Time frame: Baseline, 0.5 hr, 1 hr, 2hrs, 3hrs, and 5hrs post high-fat meal consumption

    blood sample collected by venipuncture to measure total cholesterol in plasma

  11. Change from baseline in plasma HDL at 0.5 hr, 1 hr, 2hrs, 3hrs, and 5hrs post high-fat meal consumption

    Time frame: Baseline, 0.5 hr, 1 hr, 2hrs, 3hrs, and 5hrs post high-fat meal consumption

    blood sample collected by venipuncture to measure HDL in plasma

  12. Change from baseline in plasma LDL at 0.5 hr, 1 hr, 2hrs, 3hrs, and 5hrs post high-fat meal consumption

    Time frame: Baseline, 0.5 hr, 1 hr, 2hrs, 3hrs, and 5hrs post high-fat meal consumption

    blood sample collected by venipuncture to measure LDL in plasma

  13. Change from baseline in plasma zonulin at 0.5 hr, 1 hr, 2hrs, 3hrs, and 5hrs post high-fat meal consumption

    Time frame: Baseline, 0.5 hr, 1 hr, 2hrs, 3hrs, and 5hrs post high-fat meal consumption

    blood sample collected by venipuncture to measure zonulin in plasma

  14. Change from baseline in plasma total polyphenols at 0.5 hr, 1 hr, 2hrs, 3hrs, and 5hrs post high-fat meal consumption

    Time frame: Baseline, 0.5 hr, 1 hr, 2hrs, 3hrs, and 5hrs post high-fat meal consumption

    blood sample collected by venipuncture to measure total polyphenols in plasma

  15. Change from baseline in plasma total anthocyanidins at 0.5 hr, 1 hr, 2hrs, 3hrs, and 5hrs post high-fat meal consumption

    Time frame: Baseline, 0.5 hr, 1 hr, 2hrs, 3hrs, and 5hrs post high-fat meal consumption

    blood sample collected by venipuncture to measure total anthycyanidins in plasma

  16. Change from baseline in plasma total catechins at 0.5 hr, 1 hr, 2hrs, 3hrs, and 5hrs post high-fat meal consumption

    Time frame: Baseline, 0.5 hr, 1 hr, 2hrs, 3hrs, and 5hrs post high-fat meal consumption

    blood sample collected by venipuncture to measure total catechins in plasma

  17. Change from baseline in plasma glucose at 0.5 hr, 1 hr, 2hrs, 3hrs, and 5hrs post high-fat meal consumption

    Time frame: Baseline, 0.5 hr, 1 hr, 2hrs, 3hrs, and 5hrs post high-fat meal consumption

    blood sample collected by venipuncture to measure glucose in plasma

  18. Change from baseline in PBMC IL-8 at 0.5 hr, 1 hr, 2hrs, 3hrs, and 5hrs post high-fat meal consumption

    Time frame: Baseline, 0.5 hr, 1 hr, 2hrs, 3hrs, and 5hrs post high-fat meal consumption

    blood sample collected by venipuncture to measure IL-8 in PBMC

  19. Change from baseline in PBMC IL-10 at 0.5 hr, 1 hr, 2hrs, 3hrs, and 5hrs post high-fat meal consumption

    Time frame: Baseline, 0.5 hr, 1 hr, 2hrs, 3hrs, and 5hrs post high-fat meal consumption

    blood sample collected by venipuncture to measure IL-10 in PBMC

  20. Change from baseline in PBMC IL-1β at 0.5 hr, 1 hr, 2hrs, 3hrs, and 5hrs post high-fat meal consumption

    Time frame: Baseline, 0.5 hr, 1 hr, 2hrs, 3hrs, and 5hrs post high-fat meal consumption

    blood sample collected by venipuncture to measure IL-1β in PBMC

  21. Change from baseline in PBMC IL-12p70 at 0.5 hr, 1 hr, 2hrs, 3hrs, and 5hrs post high-fat meal consumption

    Time frame: Baseline, 0.5 hr, 1 hr, 2hrs, 3hrs, and 5hrs post high-fat meal consumption

    blood sample collected by venipuncture to measure IL-12p70 in PBMC

  22. Change from baseline in PBMC TNFa at 0.5 hr, 1 hr, 2hrs, 3hrs, and 5hrs post high-fat meal consumption

    Time frame: Baseline, 0.5 hr, 1 hr, 2hrs, 3hrs, and 5hrs post high-fat meal consumption

    blood sample collected by venipuncture to measure TNFa in PBMC

  23. Change from baseline in PBMC NF-kB at 0.5 hr, 1 hr, 2hrs, 3hrs, and 5hrs post high-fat meal consumption

    Time frame: Baseline, 0.5 hr, 1 hr, 2hrs, 3hrs, and 5hrs post high-fat meal consumption

    blood sample collected by venipuncture to measure NF-kB in PBMC

  24. Change from baseline in fingerstick triglycerides at 15 minutes post high-fat meal consumption

    Time frame: Baseline, and 15 minutes post high-fat meal consumption

    blood sample collected by fingerstick to measure triglycerides

  25. Change from baseline in fingerstick total cholesterol at 15 minutes post high-fat meal consumption

    Time frame: Baseline, and 15 minutes post high-fat meal consumption

    blood sample collected by fingerstick to measure total cholesterol

  26. Change from baseline in fingerstick HDL at 15 minutes post high-fat meal consumption

    Time frame: Baseline, and 15 minutes post high-fat meal consumption

    blood sample collected by fingerstick to measure HDL

  27. Change from baseline in fingerstick LDL at 15 minutes post high-fat meal consumption

    Time frame: Baseline, and 15 minutes post high-fat meal consumption

    blood sample collected by fingerstick to measure LDL

  28. Change from baseline in fingerstick glucose at 15 minutes post high-fat meal consumption

    Time frame: Baseline, and 15 minutes post high-fat meal consumption

    blood sample collected by fingerstick to measure glucose

Sponsors and collaborators

Lead sponsor

Pharmanex

Industry

Registry information

Official study title

A Randomized Placebo-controlled Cross-over Design Study Investigating the Effects of a Plant Polyphenol Blend on the Intestinal Inflammatory and Metabolic Responses to a High Fat Meal in Healthy Subjects

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Oct 16, 2017
Registry last updated
Apr 20, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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