Thermic Effect of Feeding in Cystic Fibrosis

• ClinicalTrials.gov Identifier: NCT03931252
• Recruitment Status: Withdrawn
• First Posted: April 30, 2019
• Last Update Posted: January 31, 2022
• Sponsor: Virginia Commonwealth University
• Information provided by (Responsible Party): Virginia Commonwealth University

Study Description

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).

Condition or disease	Intervention/treatment	Phase
Cystic Fibrosis	Dietary Supplement: Boost VHC; Dietary Supplement: Ensure High Protein	Not Applicable

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 0 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: None (Open Label)
• Primary Purpose: Basic Science
• Official Title: Thermic Effect of Feeding in Cystic Fibrosis
• Estimated Study Start Date: January 2022
• Estimated Primary Completion Date: December 2022
• Estimated Study Completion Date: December 2022

Arms and Interventions

Arm	Intervention/treatment
Experimental: High fat; Boost VHC (Very High Calorie), Nestle, 8 ounce can	Dietary Supplement: Boost VHC; 8 ounce can liquid meal, calories 530kcal, Carbohydrate 46g, Protein 22g, Fat 30g
Experimental: High protein; Ensure High Protein 8 ounce can	Dietary Supplement: Ensure High Protein; 8 ounce can liquid meal, calories 160kcal, Carbohydrate 13g, Protein 16g, Fat 2g

Outcome Measures

Primary Outcome Measures :

1. Energy Expenditure [ Time Frame: 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 :

1. glucose [ Time Frame: 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
2. insulin [ Time Frame: 16 hours after entry into metabolic chamber ]
   fasting insulin level (mIU/mL) measured at end of overnight visit
3. Leptin [ Time Frame: 16 hours after entry into metabolic chamber ]
   fasting leptin level (ng/mL) measured at end of overnight visit
4. Ghrelin [ Time Frame: 16 hours after entry into metabolic chamber ]
   fasting grehlin levels (pg/mL) measured at end of overnight visit

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

United States, Virginia

Virginia Commonwealth University

Richmond, Virginia, United States, 23236

Sponsors and Collaborators

Virginia Commonwealth University

Investigators

• Principal Investigator: Trang Le, MD; Virginia Commonwealth University

More Information

• Responsible Party: Virginia Commonwealth University
• ClinicalTrials.gov Identifier: NCT03931252
• Other Study ID Numbers: HM20015037
• First Posted: April 30, 2019
• Last Update Posted: January 31, 2022
• Last Verified: January 2022

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Cystic Fibrosis; Fibrosis; Pathologic Processes; Pancreatic Diseases; Digestive System Diseases; Lung Diseases; Respiratory Tract Diseases; Genetic Diseases, Inborn; Infant, Newborn, Diseases