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

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.

Study Overview

• Status: Completed
• Conditions: Obesity; Over-eating
• Intervention / Treatment: Other: 20% fewer calories; Other: 40% fewer calories

• Study Type: Observational
• Enrollment (Actual): 22

Contacts and Locations

Study Locations

• United States
  • North Dakota
    • Grand Forks, North Dakota, United States, 58203
      • USDA Grand Forks Human Nutrition Research Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Men & Women age 18 to 65 years with a BMI of 25- 40 kg/m2.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
20% calorie depletion; During each 11-day stays the volunteer will have 9 days of calorie depletion (20% one stay and 40% the other).	Other: 20% fewer calories; Other: 40% fewer calories
40% calorie depletion; During each 11-day stays the volunteer will have 9 days of calorie depletion (20% one stay and 40% the other).	Other: 20% fewer calories; Other: 40% fewer calories

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: USDA Grand Forks Human Nutrition Research Center
• Investigators: Principal Investigator: James N Roemmich, PhD, USDA Grand Forks Human Nutrition Research Center

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2013
• Primary Completion (Actual): November 1, 2016
• Study Completion (Actual): November 1, 2016

Study Registration Dates

• First Submitted: September 12, 2013
• First Submitted That Met QC Criteria: October 29, 2013
• First Posted (Estimate): November 5, 2013

Study Record Updates

• Last Update Posted (Actual): February 2, 2022
• Last Update Submitted That Met QC Criteria: January 18, 2022
• Last Verified: January 1, 2022

More Information

Terms related to this study

• Keywords: obesity; metabolic chamber; carbon13; over-eating; room calorimeter
• Additional Relevant MeSH Terms: Signs and Symptoms, Digestive; Hyperphagia
• Other Study ID Numbers: GFHNRC505

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO