Thermic Effect of Feeding in Cystic Fibrosis | NCT03931252

Studies
Thermic Effect of Feeding in Cystic Fibrosis

NCT03931252

Sponsor

Virginia Commonwealth University

Status

Withdrawn

Last Update Posted

Jan 31, 2022Actual

Enrollment

0Actual

Phase

Not Applicable

Conditions

Cystic Fibrosis

Interventions

Boost VHC
Ensure High Protein

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2022

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Unable to recruit participants

Expanded Access Info

Start Date

Jan 2022Estimated

Primary Completion Date

Dec 2022Estimated

Completion Date

Dec 2022Estimated

First Submitted Date

Apr 25, 2019

First Submission Date that Met QC Criteria

Apr 25, 2019

First Posted Date

Apr 30, 2019Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 19, 2022

Last Update Posted Date

Jan 31, 2022Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Boost VHC	Dietary Supplement	8 ounce can liquid meal, calories 530kcal, Carbohydrate 46g, Protein 22g, Fat 30g	High fat

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
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
insulin	fasting insulin level (mIU/mL) measured at end of overnight visit

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Trang Le, MD	Virginia Commonwealth University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Virginia Commonwealth University		Richmond	Virginia	23236	United States

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D003550	Cystic Fibrosis

Ancestor Terms

ID	Term
D010182	Pancreatic Diseases
D004066	Digestive System Diseases
D008171	Lung Diseases
D012140	Respiratory Tract Diseases

Browse Leaves

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Browse Branches

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