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
About this trial
This is an interventional prevention trial for Metabolic Syndrome
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
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
NCT ID
NCT02323828
First Posted
December 15, 2014
Last Updated
January 26, 2016
Sponsor
Catholic University of the Sacred Heart
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
Learn more about this trial
High Resistant Starch (RS) Cookies and Appetite Control
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