Thermic Effect of Feeding in Cystic Fibrosis

Cystic Fibrosis Clinical Trial

Official title:

Thermic Effect of Feeding in Cystic Fibrosis

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03931252
• Other study ID #: HM20015037
• Status: Withdrawn
• Phase: N/A
• Start date: January 2022
• Est. completion date: December 2022

Study information

• Verified date: January 2022
• Source: Virginia Commonwealth University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 2022
• Est. primary completion date: December 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cystic Fibrosis
• Fibrosis

Intervention

Dietary Supplement:
• Boost VHC
8 ounce can liquid meal, calories 530kcal, Carbohydrate 46g, Protein 22g, Fat 30g
• Ensure High Protein
8 ounce can liquid meal, calories 160kcal, Carbohydrate 13g, Protein 16g, Fat 2g

Locations

Country	Name	City	State
United States	Virginia Commonwealth University	Richmond	Virginia

Sponsors (1)

Lead Sponsor	Collaborator
Virginia Commonwealth University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	glucose	blood glucose (mg/dL) measured with continuous glucose sensor and fasting venous sample at end of study visit	16 hours after entry into metabolic chamber
Secondary	insulin	fasting insulin level (mIU/mL) measured at end of overnight visit	16 hours after entry into metabolic chamber
Secondary	Leptin	fasting leptin level (ng/mL) measured at end of overnight visit	16 hours after entry into metabolic chamber
Secondary	Ghrelin	fasting grehlin levels (pg/mL) measured at end of overnight visit	16 hours after entry into metabolic chamber