Thermic Effect of Feeding in Cystic Fibrosis

• Register: ClinicalTrials.gov
• Last refreshed on: 4 October 2021
• Main ID: NCT03931252
• Date of registration: 25/04/2019
• Prospective Registration: Yes
• Primary sponsor: Virginia Commonwealth University
• Public title: Thermic Effect of Feeding in Cystic Fibrosis
• Scientific title: Thermic Effect of Feeding in Cystic Fibrosis
• Date of first enrolment: January 2022
• Target sample size: 10
• Recruitment status: Enrolling by invitation
• URL: https://clinicaltrials.gov/show/NCT03931252
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Crossover Assignment. Primary purpose: Basic Science. Masking: None (Open Label).
• Phase: N/A

Countries of recruitment

United States

Contacts

• Name: Trang Le, MD
• Affiliation: Virginia Commonwealth University

Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Cystic Fibrosis

Intervention(s)

Dietary Supplement: Ensure High Protein

Dietary Supplement: Boost VHC

Primary Outcome(s)

Energy Expenditure [Time Frame: 16 hours after entry into metabolic chamber]

Secondary Outcome(s)

glucose [Time Frame: 16 hours after entry into metabolic chamber]

Leptin [Time Frame: 16 hours after entry into metabolic chamber]

insulin [Time Frame: 16 hours after entry into metabolic chamber]

Ghrelin [Time Frame: 16 hours after entry into metabolic chamber]

Secondary ID(s)

HM20015037

Source(s) of Monetary Support

Please refer to primary and secondary sponsors