Thermic Effect of Feeding in Cystic Fibrosis

NCT ID: NCT03931252

Last Updated: 2022-01-31

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-01-31
• Study Completion Date: 2022-12-31

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.

Conditions

Cystic Fibrosis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

High fat

Boost VHC (Very High Calorie), Nestle, 8 ounce can

Group Type: EXPERIMENTAL

Boost VHC

Intervention Type: DIETARY_SUPPLEMENT

8 ounce can liquid meal, calories 530kcal, Carbohydrate 46g, Protein 22g, Fat 30g

High protein

Ensure High Protein 8 ounce can

Group Type: EXPERIMENTAL

Ensure High Protein

Intervention Type: DIETARY_SUPPLEMENT

8 ounce can liquid meal, calories 160kcal, Carbohydrate 13g, Protein 16g, Fat 2g

Interventions

Boost VHC

8 ounce can liquid meal, calories 530kcal, Carbohydrate 46g, Protein 22g, Fat 30g

Intervention Type: DIETARY_SUPPLEMENT

Ensure High Protein

8 ounce can liquid meal, calories 160kcal, Carbohydrate 13g, Protein 16g, Fat 2g

Intervention Type: DIETARY_SUPPLEMENT

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Virginia Commonwealth University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Trang Le, MD

Role: PRINCIPAL_INVESTIGATOR

Virginia Commonwealth University

Locations

Virginia Commonwealth University

Richmond, Virginia, United States

Countries

United States

Other Identifiers

HM20015037

Identifier Type: -

Identifier Source: org_study_id