High Resistant Starch (RS) Cookies and Appetite Control

Sponsor

Catholic University of the Sacred Heart (Other)

Overall Status

Completed

CT.gov ID

NCT02323828

Collaborator

(none)

Enrollment

Arms

Duration (Months)

Study Details

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).

Condition or Disease	Intervention/Treatment	Phase
Metabolic Syndrome	Dietary Supplement: High RS cookies Dietary Supplement: Placebo	Early Phase 1

Study Design

Study Type:

Interventional

Actual Enrollment :

18 participants

Allocation:

Randomized

Intervention Model:

Single Group Assignment

Masking:

Single (Participant)

Primary Purpose:

Prevention

Official Title:

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

Study Start Date :

Jan 1, 2013

Actual Primary Completion Date :

Mar 1, 2013

Actual Study Completion Date :

Jun 1, 2013

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Consumption of RS on appetite regulation [One day]
Ad libitum test meal
Consumption of RS on appetite regulation [One day]
12-h diet diaries

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years to 24 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Catholic University of the Sacred Heart

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Filippo Rossi, researcher, Catholic University of the Sacred Heart

ClinicalTrials.gov Identifier:

NCT02323828

Other Study ID Numbers:

24238/14

First Posted:

Dec 24, 2014

Last Update Posted:

Jan 27, 2016

Last Verified:

Jan 1, 2016

Additional relevant MeSH terms:

Metabolic Syndrome

Study Results

No Results Posted as of Jan 27, 2016