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Clinical Trials/NCT02323828
NCT02323828CompletedPhase 1

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

Catholic University of the Sacred Heart0 sites18 target enrollmentStarted: January 1, 2013Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Phase 1
Status
Completed
Enrollment
18
Primary Endpoint
Consumption of RS on appetite regulation

Study Overview

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).

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Single Group
Primary Purpose
Prevention
Masking
Single (Participant)

Eligibility Criteria

Ages
20 Years to 24 Years (Adult)
Sex
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

Arms & Interventions

Investigational product

Experimental

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.

Intervention: High RS cookies (Dietary Supplement)

Placebo

Placebo Comparator

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: Placebo (Dietary Supplement)

Outcomes

Primary Outcomes

Consumption of RS on appetite regulation

Time Frame: One day

Ad libitum test meal

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Filippo Rossi

researcher

Catholic University of the Sacred Heart

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