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The Breathe Light Study

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01976455
Enrollment
22
Registered
2013-11-05
Start date
2013-10-31
Completion date
2016-11-30
Last updated
2022-02-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obesity, Over-eating

Keywords

obesity, carbon13, over-eating, metabolic chamber, room calorimeter

Brief 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.

Interventions

OTHER20% fewer calories
OTHER40% fewer calories

Sponsors

USDA Grand Forks Human Nutrition Research Center
Lead SponsorFED

Study design

Observational model
CASE_CROSSOVER
Time perspective
OTHER

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Increase in breath Carbon 13 with overconsumption of calories11 daysA period of positive energy balance following one of negative energy balance increase breath Carbon13.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026