The Breathe Light Study

Completed

• Conditions: Over-eating; Obesity
• Interventions: Other: 20% fewer calories; Other: 40% fewer calories

• Registration Number: NCT01976455
• Lead Sponsor: USDA Grand Forks Human Nutrition Research Center

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-09-12
• Study Start: 2013-10
• Study First Submitted QC: 2013-10-29
• Study First Posted: 2013-11-05
• Primary Completion: 2016-11
• Study Completion: 2016-11
• Status Verified: 2022-01
• Last Update Submitted: 2022-01-18
• Last Update Posted: 2022-02-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 22

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Increase in breath Carbon 13 with overconsumption of calories	11 days	A period of positive energy balance following one of negative energy balance increase breath Carbon13.

Trial Locations

Locations (1)

USDA Grand Forks Human Nutrition Research Center; 🇺🇸 Grand Forks, North Dakota, United States