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High Resistant Starch (RS) Cookies and Appetite Control (RS)

Primary Purpose

Metabolic Syndrome

Status
Completed
Phase
Early Phase 1
Locations
Study Type
Interventional
Intervention
High RS cookies
Placebo
Sponsored by
Catholic University of the Sacred Heart
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Metabolic Syndrome

Eligibility Criteria

20 Years - 24 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • self-reported healthy
  • not suffering disorders of lipid metabolism and eating disorders

Exclusion Criteria:

  • pregnant or breast-feeding
  • consuming an energy-restricted diet
  • vegan or vegetarians

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Placebo Comparator

    Arm Label

    Investigational product

    Placebo

    Arm Description

    The investigational products are RS starch cookies (40 g resistant starch) from high amylose maize starch. Nine young healthy volunteers (males and females) consumed RS rich cookies (40 g RS) in two separate occasions.

    The placebo products are common wheat-maize cookies (2 g RS). Nine young healthy volunteers (males and females) consumed placebo in two separate occasions.

    Outcomes

    Primary Outcome Measures

    Consumption of RS on appetite regulation
    Ad libitum test meal
    Consumption of RS on appetite regulation
    12-h diet diaries

    Secondary Outcome Measures

    Full Information

    First Posted
    December 15, 2014
    Last Updated
    January 26, 2016
    Sponsor
    Catholic University of the Sacred Heart
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02323828
    Brief Title
    High Resistant Starch (RS) Cookies and Appetite Control
    Acronym
    RS
    Official Title
    Effect of High Resistant Starch-cookies on Food Ingestion and Appetite Control in a Cohort of Healthy Students
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    January 2016
    Overall Recruitment Status
    Completed
    Study Start Date
    January 2013 (undefined)
    Primary Completion Date
    March 2013 (Actual)
    Study Completion Date
    June 2013 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Catholic University of the Sacred Heart

    4. Oversight

    5. Study Description

    Brief Summary
    Evaluation of the effect of ingestion of high RS-cookies prepared from high amylose corn starch on food intake and appetite control of a cohort of healthy students. Cookies were prepared with increasing RS content and were fed to 18 healthy students in a blind trial versus a placebo. Parameters of interest were: short and long time intake (ad libitum test meal and 12 h diet diaries, respectively).

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Metabolic Syndrome

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Early Phase 1
    Interventional Study Model
    Single Group Assignment
    Masking
    Participant
    Allocation
    Randomized
    Enrollment
    18 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Investigational product
    Arm Type
    Experimental
    Arm Description
    The investigational products are RS starch cookies (40 g resistant starch) from high amylose maize starch. Nine young healthy volunteers (males and females) consumed RS rich cookies (40 g RS) in two separate occasions.
    Arm Title
    Placebo
    Arm Type
    Placebo Comparator
    Arm Description
    The placebo products are common wheat-maize cookies (2 g RS). Nine young healthy volunteers (males and females) consumed placebo in two separate occasions.
    Intervention Type
    Dietary Supplement
    Intervention Name(s)
    High RS cookies
    Intervention Description
    High RS cookies ingestion in healthy young adults
    Intervention Type
    Dietary Supplement
    Intervention Name(s)
    Placebo
    Intervention Description
    Placebo cookies ingestion in healthy young adults
    Primary Outcome Measure Information:
    Title
    Consumption of RS on appetite regulation
    Description
    Ad libitum test meal
    Time Frame
    One day
    Title
    Consumption of RS on appetite regulation
    Description
    12-h diet diaries
    Time Frame
    One day

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    20 Years
    Maximum Age & Unit of Time
    24 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: self-reported healthy not suffering disorders of lipid metabolism and eating disorders Exclusion Criteria: pregnant or breast-feeding consuming an energy-restricted diet vegan or vegetarians

    12. IPD Sharing Statement

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