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

January 26, 2016 updated by: Filippo Rossi, Catholic University of the Sacred Heart

Effect of High Resistant Starch-cookies on Food Ingestion and Appetite Control in a Cohort of Healthy Students

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

18

Phase

  • Early Phase 1

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

Ages Eligible for Study

16 years to 20 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

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: Prevention
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Investigational product

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.
Dietary supplement: High RS cookies
High RS cookies ingestion in healthy young adults
Placebo Comparator: Placebo
The placebo products are common wheat-maize cookies (2 g RS). Nine young healthy volunteers (males and females) consumed placebo in two separate occasions.
Dietary supplement: Placebo
Placebo cookies ingestion in healthy young adults

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Consumption of RS on appetite regulation
Time Frame: One day
Ad libitum test meal
One day
Consumption of RS on appetite regulation
Time Frame: One day
12-h diet diaries
One day

Collaborators and Investigators

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

Sponsor

Catholic University of the Sacred Heart

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

January 1, 2013

Primary Completion (Actual)

March 1, 2013

Study Completion (Actual)

June 1, 2013

Study Registration Dates

First Submitted

December 15, 2014

First Submitted That Met QC Criteria

December 23, 2014

First Posted (Estimate)

December 24, 2014

Study Record Updates

Last Update Posted (Estimate)

January 27, 2016

Last Update Submitted That Met QC Criteria

January 26, 2016

Last Verified

January 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 24238/14

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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