Thermic Effect of Feeding in Cystic Fibrosis

Not Applicable

Withdrawn

• Conditions: Cystic Fibrosis
• Interventions: Dietary Supplement: Boost VHC; Dietary Supplement: Ensure High Protein

• Registration Number: NCT03931252
• Lead Sponsor: Virginia Commonwealth University

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.

Study Timeline

• Study First Submitted: 2019-04-25
• Study First Submitted QC: 2019-04-25
• Study First Posted: 2019-04-30
• Status Verified: 2022-01
• Study Start: 2022-01
• Last Update Submitted: 2022-01-19
• Last Update Posted: 2022-01-31
• Primary Completion: 2022-12
• Study Completion: 2022-12

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
High fat	Boost VHC	Boost VHC (Very High Calorie), Nestle, 8 ounce can
High protein	Ensure High Protein	Ensure High Protein 8 ounce can

Primary Outcome Measures

Name	Time	Method
Energy Expenditure	16 hours after entry into metabolic chamber	The changes in energy expenditure measured in kcal (resting energy expenditure prior to feeding, and thermic effect of food after meal administration) will be recorded in the metabolic chamber.

Secondary Outcome Measures

Name	Time	Method
Leptin	16 hours after entry into metabolic chamber	fasting leptin level (ng/mL) measured at end of overnight visit
glucose	16 hours after entry into metabolic chamber	blood glucose (mg/dL) measured with continuous glucose sensor and fasting venous sample at end of study visit
insulin	16 hours after entry into metabolic chamber	fasting insulin level (mIU/mL) measured at end of overnight visit
Ghrelin	16 hours after entry into metabolic chamber	fasting grehlin levels (pg/mL) measured at end of overnight visit

Trial Locations

Locations (1)

Virginia Commonwealth University; 🇺🇸 Richmond, Virginia, United States