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Thermic Effect of Feeding in Cystic Fibrosis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03931252
Recruitment Status : Enrolling by invitation
First Posted : April 30, 2019
Last Update Posted : June 29, 2020
Sponsor:
Information provided by (Responsible Party):
Virginia Commonwealth University

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 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 : August 2020
Estimated Primary Completion Date : July 2021
Estimated Study Completion Date : July 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cystic Fibrosis

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




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



Information from the National Library of Medicine

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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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03931252


Locations
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United States, Virginia
Virginia Commonwealth University
Richmond, Virginia, United States, 23236
Sponsors and Collaborators
Virginia Commonwealth University
Investigators
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Principal Investigator: Trang Le, MD Virginia Commonwealth University
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Responsible Party: Virginia Commonwealth University
ClinicalTrials.gov Identifier: NCT03931252    
Other Study ID Numbers: HM20015037
First Posted: April 30, 2019    Key Record Dates
Last Update Posted: June 29, 2020
Last Verified: June 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Cystic Fibrosis
Fibrosis
Pathologic Processes
Pancreatic Diseases
Digestive System Diseases
Lung Diseases
Respiratory Tract Diseases
Genetic Diseases, Inborn
Infant, Newborn, Diseases