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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02323828
Other study ID # 24238/14
Secondary ID
Status Completed
Phase Phase 0
First received December 15, 2014
Last updated January 26, 2016
Start date January 2013
Est. completion date June 2013

Study information

Verified date January 2016
Source Catholic University of the Sacred Heart
Contact n/a
Is FDA regulated No
Health authority Italy: Ministry of Health
Study type Interventional

Clinical Trial 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).


Recruitment information / eligibility

Status Completed
Enrollment 18
Est. completion date June 2013
Est. primary completion date March 2013
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 20 Years to 24 Years
Eligibility 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

Allocation: Randomized, Intervention Model: Single Group Assignment, Masking: Single Blind (Subject), Primary Purpose: Prevention


Related Conditions & MeSH terms


Intervention

Dietary Supplement:
High RS cookies
High RS cookies ingestion in healthy young adults
Placebo
Placebo cookies ingestion in healthy young adults

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Catholic University of the Sacred Heart

Outcome

Type Measure Description Time frame Safety issue
Primary Consumption of RS on appetite regulation Ad libitum test meal One day No
Primary Consumption of RS on appetite regulation 12-h diet diaries One day No
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