The Breathe Light Study

NCT ID: NCT01976455

Last Updated: 2022-02-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

22 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-10-31

Study Completion Date

2016-11-30

Brief Summary

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The purpose of this study is to develop a novel, non-invasive method that will provide personalized feedback during dietary interventions as a marker for compliance.

Detailed Description

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Conditions

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Over-eating Obesity

Study Design

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Observational Model Type

CASE_CROSSOVER

Study Time Perspective

OTHER

Study Groups

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20% calorie depletion

During each 11-day stays the volunteer will have 9 days of calorie depletion (20% one stay and 40% the other).

20% fewer calories

Intervention Type OTHER

40% fewer calories

Intervention Type OTHER

40% calorie depletion

During each 11-day stays the volunteer will have 9 days of calorie depletion (20% one stay and 40% the other).

20% fewer calories

Intervention Type OTHER

40% fewer calories

Intervention Type OTHER

Interventions

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20% fewer calories

Intervention Type OTHER

40% fewer calories

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* 18 to 65 years old
* Overweight (BMI 25-40 kg/m2)

Exclusion Criteria

* Metabolic or cardiovascular abnormalities (diabetes, uncontrolled hypertension, etc.)
* Gastrointestinal disorders
* Disease that affects macronutrient utilization
* Medication that affects macronutrient utilization
* Allergies to foods to be utilized in the study (including but not limited to lactose intolerance/milk allergy)
* Use of nutritional/sport supplements
* Pregnant or currently trying to become pregnant
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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USDA Grand Forks Human Nutrition Research Center

FED

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Shanon Casperson, PhD

Role: PRINCIPAL_INVESTIGATOR

USDA Grand Forks Human Nutrition Research Center

James N Roemmich, PhD

Role: PRINCIPAL_INVESTIGATOR

USDA Grand Forks Human Nutrition Research Center

Locations

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USDA Grand Forks Human Nutrition Research Center

Grand Forks, North Dakota, United States

Site Status

Countries

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United States

Other Identifiers

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GFHNRC505

Identifier Type: -

Identifier Source: org_study_id

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