High Resistant Starch (RS) Cookies and Appetite Control

Early Phase 1

Completed

• Conditions: Metabolic Syndrome
• Interventions: Dietary Supplement: Placebo; Dietary Supplement: High RS cookies

• Registration Number: NCT02323828
• Lead Sponsor: Catholic University of the Sacred Heart

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2013-01
• Primary Completion: 2013-03
• Study Completion: 2013-06
• Study First Submitted: 2014-12-15
• Study First Submitted QC: 2014-12-23
• Study First Posted: 2014-12-24
• Status Verified: 2016-01
• Last Update Submitted: 2016-01-26
• Last Update Posted: 2016-01-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 18

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Placebo	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.
Investigational product	High RS cookies	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.

Primary Outcome Measures

Name	Time	Method
Consumption of RS on appetite regulation	One day	12-h diet diaries