Clinical trial NCT03931252: Thermic Effect of Feeding in Cystic Fibrosis
Official title: Thermic Effect of Feeding in Cystic Fibrosis
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Cystic Fibrosis
Lead sponsor: Virginia Commonwealth University
Sponsor class: OTHER
First posted: 2019-04-30
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: The investigators propose to assess the contributions of the thermic effect of food intake (TEF), which is the amount of energy expended to digest food, to overall energy expenditure in Cystic Fibrosis (CF).

Detailed description: Total energy expenditure (TEE) is comprised of the following components: resting energy expenditure (REE), thermic effect of food intake (TEF), adaptive thermogenesis (AT). The thermic effect of food is the amount of energy expended to digest food, and can be affected by factors such as protein / fat / carbohydrate contents of meals or the amount of time over which a meal is consumed. The investigators propose to assess the contributions of the thermic effect of food intake (TEF), which is the amount of energy expended to digest food, to overall energy expenditure in CF. Participants will be assigned to either a high fat liquid meal or a high protein liquid meal and assessed for components of energy expenditure in the whole room indirect calorimeter (metabolic chamber); participants will then be crossed over to the alternate liquid meal type, and differences in resting and total energy expenditure and the thermic effect of food will be assessed between the two types of meals.

Eligibility criteria: Inclusion Criteria:

* confirmed diagnosis of cystic fibrosis by Cystic Fibrosis Foundation-established criteria
* being followed at the VCU (Virginia Commonwealth University) Adult Cystic Fibrosis Center
* pulmonary and overall health status at baseline as assessed by pulmonary function testing and screening labs (complete blood count, liver enzymes, cholesterol, HgA1c). Criteria for baseline status are established for each individual patient as part of routine CF pulmonary care.
* ability to understand the study procedures and to comply with them for the entire length of the study

Exclusion Criteria:

* experiencing any signs or symptoms consistent with a pulmonary exacerbation (a decline in pulmonary function testing from baseline, recorded as part of routine CF care)
* undergoing treatment for a pulmonary exacerbation with a change in antibiotics or steroids from their baseline medications
* tobacco users
* pregnancy

Primary outcomes:
measure: Energy Expenditure
timeFrame: 16 hours after entry into metabolic chamber
Secondary outcomes:
measure: glucose
timeFrame: 16 hours after entry into metabolic chamber
measure: insulin
timeFrame: 16 hours after entry into metabolic chamber
measure: Leptin
timeFrame: 16 hours after entry into metabolic chamber
measure: Ghrelin
timeFrame: 16 hours after entry into metabolic chamber
Other outcomes:
Locations:
city: Richmond
country: United States
facility: Virginia Commonwealth University
state: Virginia
Study officials:
affiliation: Virginia Commonwealth University
name: Trang Le, MD
role: PRINCIPAL_INVESTIGATOR
References: