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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT01758302
Other study ID # 2T32HL076134-06XX
Secondary ID 2T32HL076134-06
Status Recruiting
Phase N/A
First received December 19, 2012
Last updated December 26, 2012
Start date January 2012
Est. completion date August 2013

Study information

Verified date December 2012
Source The Miriam Hospital
Contact Xiaomeng Xu, PhD
Phone 401-793-8237
Email xxu1@lifespan.org
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 120
Est. completion date August 2013
Est. primary completion date August 2013
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- 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

Exclusion Criteria:

- 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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Basic Science


Related Conditions & MeSH terms


Intervention

Behavioral:
Simple physical task
Participants are asked to complete a 1-time simple physical task that is not challenging nor novel (moving small objects across a room).
Complex physical task
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).
Other:
Cookies
Participants are asked to taste test chocolate chip cookies
Vegetables
Participants are asked to taste test raw celery or radishes
Behavioral:
No physical task
As a control, for 2 of the arms, participants are not asked to engage in a physical task

Locations

Country Name City State
United States The Miriam Hospital's Weight Control and Diabetes Research Center Providence Rhode Island

Sponsors (2)

Lead Sponsor Collaborator
The Miriam Hospital National Heart, Lung, and Blood Institute (NHLBI)

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 No
Secondary food preference Food preference measured via participant's reported ratings after tasting different food. 1 hour No
Secondary Amount of food eaten Amount of food that participants eat will be measured via a food scale at the end of the study. 1 hour No
Secondary Mood Participant's subjective mood will be measured using a mood questionnaire (PANAS). 1 hour No
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