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

A Randomized Placebo Controlled Trial to Test the Acute and Chronic Effects of Fruit Polyphenols on Postprandial Indices of Chronic Disease (PPF)

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.

Study Overview

• Status: Completed
• Conditions: Overweight; Nutritional and Metabolic Disease
• Intervention / Treatment: Dietary supplement: Active Treatment Beverage; Dietary supplement: Placebo Treatment Beverage

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.

• Study Type: Interventional
• Enrollment (Actual): 34
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Illinois
    • Chicago, Illinois, United States, 60616
      • Clinical Nutrition Research Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Active Treatment Beverage; Strawberry powder and Blackcurrent extract	Dietary supplement: Active Treatment Beverage; Strawberry and Blackcurrent extract; Other Names: Active Comparator
Placebo Comparator: Placebo Treatment Beverage; Placebo Beverage	Dietary supplement: Placebo Treatment Beverage; without active components; Other Names: Placebo Comparator

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in Plasma Triglycerides Concentrations	Changes in Plasma Triglyceride concentrations during the acute phases (from 0 to 6 hrs) and over the chronic phase, assessed by iAUC	Acute Postprandial (6 h) and chronic (8 week) fasting and postprandial (6 h)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in Plasma Lipid and Lipoprotein panels	Changes in Lipids (panel) and lipoprotein particle size/density by nuclear magnetic resonance (NMR)	Acute postprandial (6 h) and chronic (8 week) fasting and postprandial (6 h)
Changes in insulin concentrations	Changes in Plasma insulin concentrations during the acute phases (from 0 to 6 hrs) and over the chronic phase, assessed by iAUC, total AUC, Cmax and TMax	Acute postprandial (6 h) and chronic (8 week) fasting and postprandial (6 h)
Changes in LDL oxidation	Changes in Plasma OxLDL concentrations during the acute phases (from 0 to 6 hrs) and over the chronic phase, assessed by iAUC, total AUC, and Cmax	Acute postprandial (6 h) and chronic (8 week) fasting and postprandial (6 h)
Changes in F2-isoprostane concentrations	Changes in Plasma F2-isoprostane concentrations during the acute phases (from 0 to 6 hrs) and over the chronic phases assessed by iAUC, total AUC, Cmax and TMax	Acute postprandial (6 h) and chronic (8 week) fasting and postprandial (6 h)

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in plasma glucose concentrations	Changes in Plasma glucose concentrations during the acute phases (from 0 to 6 hrs) and over the chronic phase, assessed by iAUC, total AUC, Cmax and TMax	Acute postprandial (6 h) and chronic (8 week) fasting and postprandial (6 h).
Changes in polyphenol anthocyanin concentrations	Changes in Plasma polyphenol anthocyanin concentrations during the acute phases (from 0 to 6 hrs) and over the chronic phase, assessed by iAUC, total AUC, Cmax and TMax	Acute postprandial (6 h) and chronic (8 week) fasting and postprandial (6 h).

Collaborators and Investigators

• Sponsor: Clinical Nutrition Research Center, Illinois Institute of Technology
• Collaborators: GlaxoSmithKline
• Investigators: Study Chair: Indika Edirisinghe, Ph.D, Illinois Instutute of Technology

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2012
• Primary Completion (Actual): March 20, 2014
• Study Completion (Actual): June 26, 2018

Study Registration Dates

• First Submitted: November 8, 2012
• First Submitted That Met QC Criteria: November 14, 2012
• First Posted (Estimate): November 21, 2012

Study Record Updates

• Last Update Posted (Actual): July 27, 2021
• Last Update Submitted That Met QC Criteria: July 26, 2021
• Last Verified: July 1, 2021

More Information

Terms related to this study

• Keywords: Overweight; Nutrition; Polyphenols; Berries; Lipid Panels
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Body Weight; Chronic Disease; Overweight; Metabolic Diseases
• Other Study ID Numbers: PPF 2012-073