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
• Status: Completed
• 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
• 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

Related Conditions & MeSH terms

• Hyperphagia
• Obesity
• Over-eating

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