Inflammatory and Metabolic Responses to Long-term Dietary Supplementation With Anthocyanin-rich Blend

NCT04637945 | Unknown

• 1 other identifier: 20-PHX-0002
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

This study will investigate the capacity of an anthocyanin-rich blend (ACRB) dietary supplement to improve the alterations in lipid and glucose homeostasis triggered by consumption of a high-fat meal. Given the impact of Western style diets and obesity on the development of type 2 diabetes, cardiovascular disease and other pathologies, this study has major public health implications.

Conditions

Anthocyanins

Outcome Measures

Primary Outcomes (1)

• Change from baseline in plasma triglycerides at week 8, both at fasting and at 0.5 hr, 1 hr, 2hrs, 3hrs, and 5hrs post high-fat meal consumption

  blood sample collected by venipuncture to measure triglycerides in plasma

  Baseline, 8 weeks

Secondary Outcomes (18)

• Change from baseline in plasma free fatty acids at week 8, both at fasting and at 0.5 hr, 1 hr, 2hrs, 3hrs, and 5hrs post high-fat meal consumption

  Baseline, 8 weeks

• Change from baseline in total free fatty acids at week 8, both at fasting and at 0.5 hr, 1 hr, 2hrs, 3hrs, and 5hrs post high-fat meal consumption

  Baseline, 8 weeks

• Change from baseline in HDL at week 8, both at fasting and at 0.5 hr, 1 hr, 2hrs, 3hrs, and 5hrs post high-fat meal consumption

  Baseline, 8 weeks

• Change from baseline in LDL at week 8, both at fasting and at 0.5 hr, 1 hr, 2hrs, 3hrs, and 5hrs post high-fat meal consumption

  Baseline, 8 weeks

• Change from baseline in glucose at week 8, both at fasting and at week 8, both at fasting and at 0.25hr, 0.5 hr, 1 hr, 2hrs, 3hrs, and 5hrs post high-fat meal consumption

  Baseline, 8 weeks

Study Arms (2)

placebo

PLACEBO COMPARATOR

The placebo will be delivered in softgels consisting of colorant, olive oil, sunflower lecithin, yellow beeswax, bovine gelatin, glycerin and water.

Other: Placebo

ACRB

EXPERIMENTAL

The ACRB product will be delivered in softgels consisting of anthocyanin-rich blend. Each softgel will contain: i) 49 mg bilberry extract; ii) 101 mg black currant extract; and iii) 303 mg black rice extract. The high ACRB will deliver at least 108 mg anthocyanins. The product will also contain olive oil, sunflower lecithin, yellow beeswax, bovine gelatin, and water.

Dietary Supplement: ACRB

Interventions

ACRB DIETARY_SUPPLEMENT

Product will be consumed once daily, preferably with breakfast.

ACRB

Placebo OTHER

Product will be consumed once daily, preferably with breakfast.

placebo

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Subject is healthy and, in the opinion of the investigator, free of any medical conditions that might affect study measurements.
• Male or female.
• Age between 18 - 40 years inclusive.
• BMI between 21 - 29.9 kg/m2.
• Female subject of childbearing potential has a negative urine pregnancy test result and agrees to use a medically approved method of birth control. Acceptable methods of birth control include: hormonal contraceptives such as oral contraceptives, hormone birth control patch (Ortho Evra), vaginal contraceptive ring (NuvaRing), injectable contraceptives (Depo-Provera, Lunelle), or hormone implant (Norplant System); double-barrier methods; non-hormonal intrauterine devices; vasectomy of partner; and non-heterosexual lifestyles.
• Subject agrees to discontinue the use of pre- and/or probiotic and/or polyphenol supplements from 30 days prior to the screening visit and throughout the study.
• Subject agrees to consume less than 1/2 cup/day of foods containing anthocyanins (such as blueberries, blackberries, bilberries, cherries, grapes, grape juice, pomegranate, raspberries, huckleberries, strawberries) and no more than 1 glass/day of red wine, 3 cups/day of tea or coffee, or 10 g/day of dark chocolate from 30 days prior to the screening visit and throughout the study.
• No known allergies to study products or components (bilberries, black currants, rice).
• Subject is willing and able to completely consume high-fat meal and assigned study products within 15 min.
• Subject is willing to consume a low fat/low flavonoid dinner the evening before visits 2, 3 and 5.
• Subject has received a complete COVID-19 vaccine and is at least 6 weeks post-vaccine at the screening visit as verified by shot record or similar documentation.
• Subject has given voluntary, written, informed consent to participate in the study.

You may not qualify if:

• Age \< 18 or \> 40 years.
• BMI \< 21 or \> 29.9 kg/m2.
• Vegan, Vegetarian, or other dietary restrictions that would not allow the subject to consume the high-fat meal.
• Current consumption of special diets (e.g. Atkins, keto, paleo, etc.).
• Current participation or enrollment in another pharmaceutical, weight-loss or nutritional clinical study within the last 30 days. Device trials are exempted.
• Regular participation in endurance exercise activities (e.g. marathon running, triathlons).
• Uncontrolled hypertension defined as diastolic blood pressure ≥ 95 mmHg and/or systolic blood pressure ≥ 160 mmHg.
• Fasting blood triglycerides \> 150 mg/dL.
• Plasma amount of triglycerides accumulated in 5 h \< 170 or \> 700 mg/dL x 5 h after high-fat meal consumption at screening visit.
• Self-reported Type 2 Diabetes
• Fasting blood glucose \< 50 mg/dL or \> 100 mg/dL.
• Hemoglobin A1c levels ≥ 5.7%.
• Current smoker or use of tobacco products within the last 180 days.
• Binge drinking (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 last 60 days.

Sponsors & Collaborators

• Pharmanex: lead

Study Sites (1)

UC Davis Nutrition Department

Davis, California, 95616, United States

Location

Study Officials

• Patricia Oteiza, PhD

  UC Davis

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 5, 2020
• First Posted: November 20, 2020
• Study Start: July 1, 2021
• Primary Completion: December 1, 2022
• Study Completion: June 1, 2023
• Last Updated: December 21, 2022

Record last verified: 2022-12

Locations

US (1)