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

NCT01729949 | Completed

• 1 other identifier: PPF 2012-073
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

Brief Summary

1. 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. 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.

Conditions

Nutritional and Metabolic Disease; Overweight

Keywords

Nutrition; Polyphenols; Berries; Overweight; Lipid Panels

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Changes in Plasma Lipid and Lipoprotein panels

  Acute postprandial (6 h) and chronic (8 week) fasting and postprandial (6 h)

• Changes in insulin concentrations

  Acute postprandial (6 h) and chronic (8 week) fasting and postprandial (6 h)

• Changes in LDL oxidation

  Acute postprandial (6 h) and chronic (8 week) fasting and postprandial (6 h)

• Changes in F2-isoprostane concentrations

  Acute postprandial (6 h) and chronic (8 week) fasting and postprandial (6 h)

Other Outcomes (2)

• Changes in plasma glucose concentrations

  Acute postprandial (6 h) and chronic (8 week) fasting and postprandial (6 h).

• Changes in polyphenol anthocyanin concentrations

  Acute postprandial (6 h) and chronic (8 week) fasting and postprandial (6 h).

Study Arms (2)

Active Treatment Beverage

ACTIVE COMPARATOR

Strawberry powder and Blackcurrent extract

Dietary Supplement: Active Treatment Beverage

Placebo Treatment Beverage

PLACEBO COMPARATOR

Placebo Beverage

Dietary Supplement: Placebo Treatment Beverage

Interventions

Active Treatment Beverage DIETARY_SUPPLEMENT

Strawberry and Blackcurrent extract

Also known as: Active Comparator

Active Treatment Beverage

Placebo Treatment Beverage DIETARY_SUPPLEMENT

without active components

Also known as: Placebo Comparator

Placebo Treatment Beverage

Eligibility Criteria

• Age: 40 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• Clinical Nutrition Research Center, Illinois Institute of Technology: lead
• GlaxoSmithKline: collaborator

Study Sites (1)

Clinical Nutrition Research Center

Chicago, Illinois, 60616, United States

Location

MeSH Terms

Conditions

Metabolic Diseases; Overweight

Condition Hierarchy (Ancestors)

Nutritional and Metabolic Diseases; Overnutrition; Nutrition Disorders; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Britt Burton-Freeman, Ph.D

  Illinois Institute of Technology

  PRINCIPAL INVESTIGATOR

• Indika Edirisinghe, Ph.D

  Illinois Instutute of Technology

  STUDY CHAIR

Study Design

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

Study Record Dates

• First Submitted: November 8, 2012
• First Posted: November 21, 2012
• Study Start: December 1, 2012
• Primary Completion: March 20, 2014
• Study Completion: June 26, 2018
• Last Updated: July 27, 2021

Record last verified: 2021-07

Locations

US (1)