NCT01712737

Brief Summary

No studies have reported the effect of pre-meal snacking on raisins compared to other commonly consumed snacks on energy intake in children. Therefore, the objective of the current study was to examine appetite and energy intake following consumption of ad libitum snack of raisins, grapes or mix of almonds and raisins, compared with a water control, on appetite and food intake 30 min later in 8 - 11 y old normal weight children. The investigators hypothesized that raisins would lower subsequent energy intake in children and reduce hunger.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
26

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2011

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, 2011

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2011

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2011

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

October 20, 2012

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 23, 2012

Completed
Last Updated

October 29, 2012

Status Verified

October 1, 2012

Enrollment Period

4 months

First QC Date

October 20, 2012

Last Update Submit

October 25, 2012

Conditions

Food Intake Regulation

Keywords

raisins, grapes, snacks, appetite, food intake

Outcome Measures

Primary Outcomes (2)

  • ad libitum snack intake (kcal)

    15 min

  • ad libitum pizza intake (kcal)

    at 30 min after treatment

Secondary Outcomes (1)

  • subjective appetite

    0-105 min

Study Arms (4)

Snack foods: raisins

EXPERIMENTAL

children were given ad libitum access to raisins for 15 min

Other: Dietary intervention

Snack foods: grapes

EXPERIMENTAL

children were given ad libitum access to grapes for 15 min

Other: Dietary intervention

Snack foods: a mix of almonds with raisins

EXPERIMENTAL

children were given ad libitum access to a mix of almonds with raisins for 15 min

Other: Dietary intervention

Water control

EXPERIMENTAL

children were given ad libitum access to water

Other: Dietary intervention

Interventions

Dietary interventionOTHER
Snack foods: a mix of almonds with raisinsSnack foods: grapesSnack foods: raisinsWater control

Eligibility Criteria

Age8 Years - 11 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Interventions

Diet Therapy

Intervention Hierarchy (Ancestors)

Nutrition TherapyTherapeutics

Study Officials

  • Harvey Anderson, PhD

    University of Toronto

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

October 20, 2012

First Posted

October 23, 2012

Study Start

January 1, 2011

Primary Completion

May 1, 2011

Study Completion

December 1, 2011

Last Updated

October 29, 2012

Record last verified: 2012-10