NCT02323828

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).

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
18

participants targeted

Target at P25-P50 for early_phase_1

Timeline
Completed

Started Jan 2013

Shorter than P25 for early_phase_1

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2013

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2013

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2013

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

December 15, 2014

Completed
9 days until next milestone

First Posted

Study publicly available on registry

December 24, 2014

Completed
Last Updated

January 27, 2016

Status Verified

January 1, 2016

Enrollment Period

2 months

First QC Date

December 15, 2014

Last Update Submit

January 26, 2016

Conditions

Metabolic Syndrome

Outcome Measures

Primary Outcomes (2)

  • Consumption of RS on appetite regulation

    Ad libitum test meal

    One day

  • Consumption of RS on appetite regulation

    12-h diet diaries

    One day

Study Arms (2)

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.

Dietary Supplement: High RS cookies

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.

Dietary Supplement: Placebo

Interventions

High RS cookiesDIETARY_SUPPLEMENT

High RS cookies ingestion in healthy young adults

Investigational product
PlaceboDIETARY_SUPPLEMENT

Placebo cookies ingestion in healthy young adults

Placebo

Eligibility Criteria

Age20 Years - 24 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • self-reported healthy
  • not suffering disorders of lipid metabolism and eating disorders

You may not qualify if:

  • pregnant or breast-feeding
  • consuming an energy-restricted diet
  • vegan or vegetarians

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Metabolic Syndrome

Condition Hierarchy (Ancestors)

Insulin ResistanceHyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
researcher

Study Record Dates

First Submitted

December 15, 2014

First Posted

December 24, 2014

Study Start

January 1, 2013

Primary Completion

March 1, 2013

Study Completion

June 1, 2013

Last Updated

January 27, 2016

Record last verified: 2016-01