Thermic Effect of Feeding in Cystic Fibrosis
Primary Purpose
Cystic Fibrosis
Status
Withdrawn
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Boost VHC
Ensure High Protein
Sponsored by
About this trial
This is an interventional basic science trial for Cystic Fibrosis
Eligibility 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
Sites / Locations
- Virginia Commonwealth University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
High fat
High protein
Arm Description
Boost VHC (Very High Calorie), Nestle, 8 ounce can
Ensure High Protein 8 ounce can
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
glucose
blood glucose (mg/dL) measured with continuous glucose sensor and fasting venous sample at end of study visit
insulin
fasting insulin level (mIU/mL) measured at end of overnight visit
Leptin
fasting leptin level (ng/mL) measured at end of overnight visit
Ghrelin
fasting grehlin levels (pg/mL) measured at end of overnight visit
Full Information
NCT ID
NCT03931252
First Posted
April 25, 2019
Last Updated
January 19, 2022
Sponsor
Virginia Commonwealth University
1. Study Identification
Unique Protocol Identification Number
NCT03931252
Brief Title
Thermic Effect of Feeding in Cystic Fibrosis
Official Title
Thermic Effect of Feeding in Cystic Fibrosis
Study Type
Interventional
2. Study Status
Record Verification Date
January 2022
Overall Recruitment Status
Withdrawn
Why Stopped
Unable to recruit participants
Study Start Date
January 2022 (Anticipated)
Primary Completion Date
December 2022 (Anticipated)
Study Completion Date
December 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Virginia Commonwealth University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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).
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cystic Fibrosis
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
High fat
Arm Type
Experimental
Arm Description
Boost VHC (Very High Calorie), Nestle, 8 ounce can
Arm Title
High protein
Arm Type
Experimental
Arm Description
Ensure High Protein 8 ounce can
Intervention Type
Dietary Supplement
Intervention Name(s)
Boost VHC
Intervention Description
8 ounce can liquid meal, calories 530kcal, Carbohydrate 46g, Protein 22g, Fat 30g
Intervention Type
Dietary Supplement
Intervention Name(s)
Ensure High Protein
Intervention Description
8 ounce can liquid meal, calories 160kcal, Carbohydrate 13g, Protein 16g, Fat 2g
Primary Outcome Measure Information:
Title
Energy Expenditure
Description
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.
Time Frame
16 hours after entry into metabolic chamber
Secondary Outcome Measure Information:
Title
glucose
Description
blood glucose (mg/dL) measured with continuous glucose sensor and fasting venous sample at end of study visit
Time Frame
16 hours after entry into metabolic chamber
Title
insulin
Description
fasting insulin level (mIU/mL) measured at end of overnight visit
Time Frame
16 hours after entry into metabolic chamber
Title
Leptin
Description
fasting leptin level (ng/mL) measured at end of overnight visit
Time Frame
16 hours after entry into metabolic chamber
Title
Ghrelin
Description
fasting grehlin levels (pg/mL) measured at end of overnight visit
Time Frame
16 hours after entry into metabolic chamber
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Trang Le, MD
Organizational Affiliation
Virginia Commonwealth University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Virginia Commonwealth University
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23236
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Thermic Effect of Feeding in Cystic Fibrosis
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