The Breathe Light Study

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.

Completed

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Key information

Conditions

Over-eating Body Weight Hyperphagia Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms Signs and Symptoms, Digestive

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

USDA Grand Forks Human Nutrition Research Center

Grand Forks, North Dakota, 58203, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

20% fewer calories

Other

40% fewer calories

Other

Primary outcomes

Increase in breath Carbon 13 with overconsumption of calories

Time frame: 11 days

A period of positive energy balance following one of negative energy balance increase breath Carbon13.

Sponsors and collaborators

Lead sponsor

USDA Grand Forks Human Nutrition Research Center

Fed

Registry information

Official study title

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

Important dates

Study start: 2013
Primary completion: 2016
Study completion: 2016
First posted: Nov 5, 2013
Registry last updated: Feb 2, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed