Thermic Effect of Feeding in Cystic Fibrosis

Sponsor

Virginia Commonwealth University (Other)

Overall Status

Withdrawn

CT.gov ID

NCT03931252

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

Patients Per Site Per Month

Study Details

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	N/A

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

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

Anticipated Study Start Date :

Jan 1, 2022

Anticipated Primary Completion Date :

Dec 1, 2022

Anticipated Study Completion Date :

Dec 1, 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

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

Energy Expenditure [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

glucose [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
insulin [16 hours after entry into metabolic chamber]
fasting insulin level (mIU/mL) measured at end of overnight visit
Leptin [16 hours after entry into metabolic chamber]
fasting leptin level (ng/mL) measured at end of overnight visit
Ghrelin [16 hours after entry into metabolic chamber]
fasting grehlin levels (pg/mL) measured at end of overnight visit

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Virginia Commonwealth University	Richmond	Virginia	United States	23236

Sponsors and Collaborators

Virginia Commonwealth University

Investigators

Principal Investigator: Trang Le, MD, Virginia Commonwealth University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Virginia Commonwealth University

ClinicalTrials.gov Identifier:

NCT03931252

Other Study ID Numbers:

HM20015037

First Posted:

Apr 30, 2019

Last Update Posted:

Jan 31, 2022

Last Verified:

Jan 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Cystic Fibrosis

Fibrosis

Study Results

No Results Posted as of Jan 31, 2022