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NCT01976455 Clinical Trial

The Breathe Light Study

Obesity Clinical Trial

Official title:
The Breathe Light Study: Validation of Carbon Stable Isotope Ratio in Breath as an Indicator of Energy Balance and Substrate Utilization

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01976455
Other study ID # GFHNRC505
Secondary ID
Status Completed
Phase
First received
Last updated
Start date October 2013
Est. completion date November 2016

Study information
Verified date January 2022
Source USDA Grand Forks Human Nutrition Research Center
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.

Recruitment information / eligibility
Status Completed
Enrollment 22
Est. completion date November 2016
Est. primary completion date November 2016
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 65 Years
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• 20% fewer calories

• 40% fewer calories

Locations
Country Name City State
United States USDA Grand Forks Human Nutrition Research Center Grand Forks North Dakota

Sponsors (1)
Lead Sponsor Collaborator
USDA Grand Forks Human Nutrition Research Center

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Increase in breath Carbon 13 with overconsumption of calories A period of positive energy balance following one of negative energy balance increase breath Carbon13. 11 days
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