NCT01758302

Brief Summary

This one time pilot laboratory study focuses on examining the relationship between different types of physical tasks and taste perception of high and low-calorie foods among hungry individuals.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2012

Geographic Reach
1 country

1 active site

Status
unknown

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, 2012

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

December 19, 2012

Completed
13 days until next milestone

First Posted

Study publicly available on registry

January 1, 2013

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2013

Completed
Last Updated

January 1, 2013

Status Verified

December 1, 2012

Enrollment Period

1.6 years

First QC Date

December 19, 2012

Last Update Submit

December 26, 2012

Conditions

Food ConsumptionPerseverance

Keywords

taste testfood consumptionhunger

Outcome Measures

Primary Outcomes (1)

  • physical perseverance

    as measured via maintained grip using a hand dynamometer on the dominant hand and set to 70% of participant's maximum grip strength

    1 hour

Secondary Outcomes (3)

  • food preference

    1 hour

  • Amount of food eaten

    1 hour

  • Mood

    1 hour

Study Arms (4)

No physical task + Taste cookies

ACTIVE COMPARATOR

Participants in this arm do not engage in a physical activity task. They are asked to taste test chocolate chip cookies.

Other: CookiesBehavioral: No physical task

No physical task + Taste vegetable

ACTIVE COMPARATOR

Participant does not complete a physical activity. Asked to taste test raw celery or radishes.

Other: VegetablesBehavioral: No physical task

Simple physical task + Taste vegetables

ACTIVE COMPARATOR

Participants are asked to complete a simple physical task and are asked to taste test raw celery or radishes.

Behavioral: Simple physical taskOther: Vegetables

Complex physical task + Taste vegetables

ACTIVE COMPARATOR

Participants complete a more complex physical task that is novel and challenging. They are asked to taste test raw celery or radishes.

Behavioral: Complex physical taskOther: Vegetables

Interventions

Simple physical taskBEHAVIORAL

Participants are asked to complete a 1-time simple physical task that is not challenging nor novel (moving small objects across a room).

Simple physical task + Taste vegetables
Complex physical taskBEHAVIORAL

Participants are asked to complete a 1-time physical task that is low intensity but somewhat complex (involves a novel request to move objects in a way that is challenging and requires some coordination).

Complex physical task + Taste vegetables
CookiesOTHER

Participants are asked to taste test chocolate chip cookies

No physical task + Taste cookies
VegetablesOTHER

Participants are asked to taste test raw celery or radishes

Complex physical task + Taste vegetablesNo physical task + Taste vegetableSimple physical task + Taste vegetables
No physical taskBEHAVIORAL

As a control, for 2 of the arms, participants are not asked to engage in a physical task

No physical task + Taste cookiesNo physical task + Taste vegetable

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Willing to travel to laboratory around lunchtime for the study
  • Willing to abstain from eating and drinking caloric beverages for at least 4 hours prior to completing the study
  • Typically eats lunch

You may not qualify if:

  • Diabetes, eating disorder, or any other condition that makes it unadvisable for participant to refrain from eating or drinking caloric beverages for 4 hours.
  • Food allergies that would prevent participants from eating chocolate chip cookies or vegetables
  • Pregnant or lactating
  • Typically goes for longer than 5 hours (not counting sleep time) between meals and snacks
  • Physical disabilities that would make it difficult for the participant to walk or to use their hands to grasp objects

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Miriam Hospital's Weight Control and Diabetes Research Center

Providence, Rhode Island, 02903, United States

RECRUITING

MeSH Terms

Interventions

Vegetables

Intervention Hierarchy (Ancestors)

FoodDiet, Food, and NutritionPhysiological PhenomenaFood and Beverages

Study Officials

  • Xiaomeng Xu, PhD

    The Miriam Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Xiaomeng Xu, PhD

CONTACT

401-793-8237xxu1@lifespan.org

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 19, 2012

First Posted

January 1, 2013

Study Start

January 1, 2012

Primary Completion

August 1, 2013

Study Completion

August 1, 2013

Last Updated

January 1, 2013

Record last verified: 2012-12

Locations

US(1)