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

July 26, 2021 updated by: Clinical Nutrition Research Center, Illinois Institute of Technology

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
34

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Changes in Plasma Triglycerides Concentrations
Time Frame: Acute Postprandial (6 h) and chronic (8 week) fasting and postprandial (6 h)
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Changes in Plasma Lipid and Lipoprotein panels
Time Frame: Acute postprandial (6 h) and chronic (8 week) fasting and postprandial (6 h)
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
Time Frame: Acute postprandial (6 h) and chronic (8 week) fasting and postprandial (6 h)
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
Time Frame: Acute postprandial (6 h) and chronic (8 week) fasting and postprandial (6 h)
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
Time Frame: Acute postprandial (6 h) and chronic (8 week) fasting and postprandial (6 h)
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

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Changes in plasma glucose concentrations
Time Frame: Acute postprandial (6 h) and chronic (8 week) fasting and postprandial (6 h).
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
Time Frame: Acute postprandial (6 h) and chronic (8 week) fasting and postprandial (6 h).
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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Clinical Nutrition Research Center, Illinois Institute of Technology

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
GlaxoSmithKline

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Chair: Indika Edirisinghe, Ph.D, Illinois Instutute of Technology

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 1, 2012

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 20, 2014

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 26, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 8, 2012

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 14, 2012

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 21, 2012

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 27, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 26, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • PPF 2012-073

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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