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Thermic Effect of Feeding in Cystic Fibrosis

Virginia Commonwealth University (VCU) logo

Virginia Commonwealth University (VCU)

Status

Withdrawn

Conditions

Cystic Fibrosis

Treatments

Dietary Supplement: Boost VHC
Dietary Supplement: Ensure High Protein

Study type

Interventional

Funder types

Other

Identifiers

NCT03931252
HM20015037

Details and patient eligibility

About

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).

Full 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.

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Basic Science

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

None (Open label)

0 participants in 2 patient groups

High fat
Experimental group
Description:
Boost VHC (Very High Calorie), Nestle, 8 ounce can
Treatment:
Dietary Supplement: Boost VHC
High protein
Experimental group
Description:
Ensure High Protein 8 ounce can
Treatment:
Dietary Supplement: Ensure High Protein

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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