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Use of Novel High-protein Food Products To Reduce Insulin Resistance

Primary Purpose

Insulin Resistance

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Food product: high-protein pasta and cereal
Sponsored by
Arizona State University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Insulin Resistance

Eligibility Criteria

20 Years - 75 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • 20-75 years of age
  • BMI 23-42 kg/m2

Exclusion Criteria:

  • food allergies
  • diet restrictions (e.g., vegetarian, gluten or lactose intolerant)
  • insulin use
  • cigarette use
  • active disease states including diagnosed diabetes
  • anticipated changes to diet or physical activity levels
  • recent weight gain or loss (±10 pounds)
  • current or recent pregnancy or lactation
  • prescription medication use by participants was allowed if use had been consistent

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Sham Comparator

    Arm Label

    Novel high-protein pasta and cereal

    Control pasta and cereal

    Arm Description

    High-protein pasta (orzo and fusilli) enriched with gluten and egg white protein (%energy: 27/30/43 for protein/fat/carbohydrate) and high-protein flaked breakfast cereal enriched with gluten (%energy: 30/35/35 for protein/fat/carbohydrate) were manufactured by Zone Inc.(Boston, MA). The study foods provided an average of 945 kcal/day (one aliquot of cereal and two pasta dishes daily). Pasta meals were prepared in a metabolic kitchen and were identical in appearance and basic taste as control meals.

    Commercial gluten-free pasta (Barcilla orzo and fusilli; %energy: 13/24/63 for protein/fat/carbohydrate) and commercial flaked cereal (Post Honey Bunches of Oats; %energy: 6/18/76 for protein/fat/carbohydrate) were used as the control foods. The study foods provided an average of 945 kcal/day (one aliquot of cereal and two pasta dishes daily). Pasta meals were prepared in a metabolic kitchen and were identical in appearance and basic taste as experimental foods.

    Outcomes

    Primary Outcome Measures

    Insulin resistance
    Change in insulin resistance
    Body composition
    Change in body composition

    Secondary Outcome Measures

    Full Information

    First Posted
    July 28, 2016
    Last Updated
    August 26, 2019
    Sponsor
    Arizona State University
    Collaborators
    Inflammation Research Foundation
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02851498
    Brief Title
    Use of Novel High-protein Food Products To Reduce Insulin Resistance
    Official Title
    Use of Novel High-protein Food Products to Reduce Insulin Resistance in Adults With an Elevated Triglyceride/HDL Ratio
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2019
    Overall Recruitment Status
    Completed
    Study Start Date
    January 2015 (Actual)
    Primary Completion Date
    December 2015 (Actual)
    Study Completion Date
    September 2016 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Arizona State University
    Collaborators
    Inflammation Research Foundation

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    This controlled weight loss trial in adults at cardiometabolic risk (elevated triglyceride/HDL ratio) followed a randomized, cross-over design and utilized novel, high-protein pasta and cereal to examine the physiological impact of stealth substitution of dietary carbohydrate with protein derived from soy concentrates, wheat protein isolates, and dried egg whites. Pasta dishes were prepared using high-protein orzo and fusilli pasta (Zone PastaRxTM) or conventional, gluten-free pasta, and high-protein flaked cereal (ZoneTM cereal) was matched with conventional flaked cereal. Participants were instructed to follow an energy restricted diet (-500 kcal/d) and incorporate a test food into each of three meals over a 24-hour period. The diet-induced changes in body mass and lean body mass were tracked as well as changes in in insulin sensitivity and common blood biomarkers.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Insulin Resistance

    7. Study Design

    Primary Purpose
    Basic Science
    Study Phase
    Not Applicable
    Interventional Study Model
    Crossover Assignment
    Masking
    ParticipantOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    39 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Novel high-protein pasta and cereal
    Arm Type
    Experimental
    Arm Description
    High-protein pasta (orzo and fusilli) enriched with gluten and egg white protein (%energy: 27/30/43 for protein/fat/carbohydrate) and high-protein flaked breakfast cereal enriched with gluten (%energy: 30/35/35 for protein/fat/carbohydrate) were manufactured by Zone Inc.(Boston, MA). The study foods provided an average of 945 kcal/day (one aliquot of cereal and two pasta dishes daily). Pasta meals were prepared in a metabolic kitchen and were identical in appearance and basic taste as control meals.
    Arm Title
    Control pasta and cereal
    Arm Type
    Sham Comparator
    Arm Description
    Commercial gluten-free pasta (Barcilla orzo and fusilli; %energy: 13/24/63 for protein/fat/carbohydrate) and commercial flaked cereal (Post Honey Bunches of Oats; %energy: 6/18/76 for protein/fat/carbohydrate) were used as the control foods. The study foods provided an average of 945 kcal/day (one aliquot of cereal and two pasta dishes daily). Pasta meals were prepared in a metabolic kitchen and were identical in appearance and basic taste as experimental foods.
    Intervention Type
    Other
    Intervention Name(s)
    Food product: high-protein pasta and cereal
    Primary Outcome Measure Information:
    Title
    Insulin resistance
    Description
    Change in insulin resistance
    Time Frame
    6 weeks
    Title
    Body composition
    Description
    Change in body composition
    Time Frame
    6 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    20 Years
    Maximum Age & Unit of Time
    75 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: 20-75 years of age BMI 23-42 kg/m2 Exclusion Criteria: food allergies diet restrictions (e.g., vegetarian, gluten or lactose intolerant) insulin use cigarette use active disease states including diagnosed diabetes anticipated changes to diet or physical activity levels recent weight gain or loss (±10 pounds) current or recent pregnancy or lactation prescription medication use by participants was allowed if use had been consistent

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided

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    Use of Novel High-protein Food Products To Reduce Insulin Resistance

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