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

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: Metabolic Syndrome
• Intervention / Treatment: Dietary supplement: High RS cookies; Dietary supplement: Placebo

• Study Type: Interventional
• Enrollment (Actual): 18
• Phase: Early Phase 1

Participation Criteria

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

How is the study designed?

Design Details

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

Number of Arms

2

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

Collaborators and Investigators

• Sponsor: Catholic University of the Sacred Heart

Study record dates

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: Glucose Metabolism Disorders; Metabolic Diseases; Insulin Resistance; Hyperinsulinism; Metabolic Syndrome
• Other Study ID Numbers: 24238/14