The Acute and Chronic Effects of Fruit Polyphenols on Chronic Disease (PPF)

NCT ID: NCT01729949

Last Updated: 2021-07-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 34 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-12-01
• Study Completion Date: 2018-06-26

Brief Summary

1. The primary objective is to determine the effect of fruit polyphenols on postprandial lipoprotein triglyceride metabolism after consumption a standard high carbohydrate/fat breakfast meal with a beverage rich in fruit-derived polyphenols compared to energy and macro-/micro-nutrient matched control beverage (acute, Part 1).

2. Secondary objectives are: 1)to assess the effects of consuming daily for 8 weeks (chronic, Part 2) a beverage rich in fruit polyphenols compared to an energy and macro-/micro- nutrient matched control beverage on fasting glucose, insulin, lipids and markers of oxidative stress; and 2) to assess the effects of these beverages on meal-related changes in metabolic and oxidative stress measures after 8 weeks daily consumption.

Detailed Description

The study is a single-center, double-blinded, randomized, 2-part, 2-arm, 4-sequence, crossover study that incorporates both the acute and chronic evaluations of fruit polyphenols on metabolic indices and markers of oxidative stress.

A planned sample size of 30 overweight men and women will be recruited into the study. Subjects will be required to meet several inclusion and exclusion criteria, which will be assessed through online and clinic screening mechanisms, including questionnaires, blood analysis, and anthropometric measurements. Eligible subjects will be invited to participate in the study. Subjects will begin by completing a 7-day pre-study assessment of their usual dietary intake using 3-day food diary followed by washout of dietary polyphenols. Subjects will participate in 4, 6 h postprandial study days: 2 preceding the chronic intervention and 2 after 8 weeks each of active (fruit polyphenols) and placebo beverages. Subjects will be randomized on the first day of starting the acute and chronic study phases. Subjects will be asked to limit polyphenolic containing foods and beverages for 3 days prior to each 6 h postprandial study visit as well through the chronic dietary intervention. Subjects will be provided a standardized dinner meal pack on the day before each 6 h postprandial visit.

For each 6 h postprandial study visit, subjects will arrive fasted and follow procedures published by our lab previously. This includes: pre-study evaluation for compliance (fasting, dinner consumption, limited polyphenol intake) and readiness for study visit, catheter placement by registered nurse, fasting blood sample, consumption of high fat/carbohydrate meal accompanied by 1 of the two treatment beverages (active/fruit polyphenol or placebo beverage), subsequent blood sampling from catheter [ ~1 tablespoon (12ml)] at designated time points for 6 hours. Each postprandial study visit day will last approximately 7 hours and subjects will be required to remain at the Clinical Nutrition Research Center at the Illinois Institute of Technology main campus for the duration of the visit. The visit procedures are repeated twice ~ 1 week apart to accommodate subject testing with both beverages.

After completing both acute 6 h postprandial study visits, subjects will roll over to the chronic phase of the study and receive a 2nd randomization sequence for consuming the active or the placebo beverage daily for 8 weeks. Before crossing over to the alternative treatment beverage for another 8 weeks, subjects will have a 4-week break (wash out). Subjects will be counseled for a low polyphenolic diet throughout the study to consume the assigned beverage twice per day with lunch and evening meals (except during 4-week washout).

At the end of each week 8 treatment period, subjects will come to the research center for a 6 h postprandial study visit day: all procedures are identical on each postprandial study test visit with the exception that only the placebo beverage will be consumed with the breakfast.

Conditions

Nutritional and Metabolic Disease; Overweight

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: QUADRUPLE

Study Groups

Active Treatment Beverage

Strawberry powder and Blackcurrent extract

Group Type: ACTIVE_COMPARATOR

Active Treatment Beverage

Intervention Type: DIETARY_SUPPLEMENT

Strawberry and Blackcurrent extract

Placebo Treatment Beverage

Placebo Beverage

Group Type: PLACEBO_COMPARATOR

Placebo Treatment Beverage

Intervention Type: DIETARY_SUPPLEMENT

without active components

Interventions

Active Treatment Beverage

Strawberry and Blackcurrent extract

Intervention Type: DIETARY_SUPPLEMENT

Placebo Treatment Beverage

without active components

Intervention Type: DIETARY_SUPPLEMENT

Other Intervention Names

Active Comparator; Placebo Comparator

Eligibility Criteria

Inclusion Criteria

• Non-smoking healthy overweight or class I obesity adult men and women
• Age 40-65yr
• Weight stable
• Able to provide informed consent
• Able to comply and perform the procedures requested by the protocol.

Exclusion Criteria

• Smokers or recent past smokers
• Men or women with known or suspected intolerance or hypersensitivity to the study materials (or closely related compounds) or any of their stated ingredients
• Diabetes
• Fasting blood glucose concentrations >125 mg/dL
• Fasting Total Cholesterol >250 mg/dL (6.47mmol/L)
• Fasting Triglycerides >250 mg/dL (2.82 mmol/L)
• Fasting LDL cholesterol >180 mg/dL (4.66 mmol/L)
• Uncontrolled blood pressure >140 mmHg/90 mmHg
• Documented vascular disease
• Cancer other than skin (non-melanoma) in previous 5 years
• Lactating and/or pregnant
• Taking medications or dietary supplements eg., antioxidant supplements, lipid lowering medication, blood pressure lowering medications.
• Recent blood donors (within 3 months)
• Vegans
• Substance (alcohol or drug) abuser (within the last 2 years)
• Participated in a chronic feeding or medication clinical trial in the last 3 months.
• Excessive coffee and tea consumers (> 4 cups/d)

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

GlaxoSmithKline

INDUSTRY

Sponsor Role: collaborator

Clinical Nutrition Research Center, Illinois Institute of Technology

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Britt Burton-Freeman, Ph.D

Role: PRINCIPAL_INVESTIGATOR

Illinois Institute of Technology

Indika Edirisinghe, Ph.D

Role: STUDY_CHAIR

Illinois Instutute of Technology

Locations

Clinical Nutrition Research Center

Chicago, Illinois, United States

Countries

United States

Other Identifiers

PPF 2012-073

Identifier Type: -

Identifier Source: org_study_id