Thermic Effect of Feeding in Cystic Fibrosis

NCT03931252 | Withdrawn

• 1 other identifier: HM20015037
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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).

Conditions

Cystic Fibrosis

Outcome Measures

Primary Outcomes (1)

• Energy Expenditure

  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.

  16 hours after entry into metabolic chamber

Secondary Outcomes (4)

• glucose

  16 hours after entry into metabolic chamber

• insulin

  16 hours after entry into metabolic chamber

• Leptin

  16 hours after entry into metabolic chamber

• Ghrelin

  16 hours after entry into metabolic chamber

Study Arms (2)

High fat

EXPERIMENTAL

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

Dietary Supplement: Boost VHC

High protein

EXPERIMENTAL

Ensure High Protein 8 ounce can

Dietary Supplement: Ensure High Protein

Interventions

Boost VHC DIETARY_SUPPLEMENT

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

High fat

Ensure High Protein DIETARY_SUPPLEMENT

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

High protein

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Virginia Commonwealth University: lead

Study Sites (1)

Virginia Commonwealth University

Richmond, Virginia, 23236, United States

Location

MeSH Terms

Conditions

Cystic Fibrosis

Condition Hierarchy (Ancestors)

Pancreatic Diseases; Digestive System Diseases; Lung Diseases; Respiratory Tract Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Infant, Newborn, Diseases

Study Officials

• Trang Le, MD

  Virginia Commonwealth University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 25, 2019
• First Posted: April 30, 2019
• Study Start: January 1, 2022
• Primary Completion: December 1, 2022
• Study Completion: December 1, 2022
• Last Updated: January 31, 2022

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)