Cystic FibrosisNCT03931252
Thermic Effect of Feeding in Cystic Fibrosis
A study testing Boost VHC and Ensure High Protein in people with Cystic Fibrosis, run by Virginia Commonwealth University at 1 site in United States.
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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cystic Fibrosis
- What is being tested?
- Boost VHC and Ensure High Protein
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2022to Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Virginia Commonwealth University
Richmond, Virginia, 23236
About this study
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).
Read the 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.
- Conditions
- Cystic Fibrosis
- Being tested
- Boost VHC, Ensure High Protein
- Medical subject headings
- Cystic Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Boost VHCDietary supplement
8 ounce can liquid meal, calories 530kcal, Carbohydrate 46g, Protein 22g, Fat 30g
Ensure High ProteinDietary supplement
8 ounce can liquid meal, calories 160kcal, Carbohydrate 13g, Protein 16g, Fat 2g
| Study group | Role | What they receive |
|---|---|---|
| High fat | Experimental | Boost VHC (Very High Calorie), Nestle, 8 ounce can Receives: Dietary Supplement: Boost VHC |
| High protein | Experimental | Ensure High Protein 8 ounce can Receives: Dietary Supplement: Ensure High Protein |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 16 hours after entry into metabolic chamber
Secondary outcomes (4)
glucose
blood glucose (mg/dL) measured with continuous glucose sensor and fasting venous sample at end of study visit
Measured: 16 hours after entry into metabolic chamber
insulin
fasting insulin level (mIU/mL) measured at end of overnight visit
Measured: 16 hours after entry into metabolic chamber
Leptin
fasting leptin level (ng/mL) measured at end of overnight visit
Measured: 16 hours after entry into metabolic chamber
Ghrelin
fasting grehlin levels (pg/mL) measured at end of overnight visit
Measured: 16 hours after entry into metabolic chamber
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2019
- Study startJan 2022 (estimated)
- Primary completionDec 2022 (estimated)
- Study completionDec 2022 (estimated)
Why it stopped: Unable to recruit participants
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cystic FibrosisStudies of the same condition, open and under way.
- More trials run by Virginia Commonwealth UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Virginia Commonwealth University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Trang Le, MD, Principal investigator, Virginia Commonwealth University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03931252
- Sponsor's protocol ID
- HM20015037
- Status last verified
- Jan 2022
- First submitted
- 25 Apr 2019
- Last updated
- 31 Jan 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Thermic Effect of Feeding in Cystic Fibrosis
- ClinicalTrials.gov ID
- NCT03931252
- Acronym / sponsor ID
- HM20015037
- Conditions
- Cystic Fibrosis
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Unable to recruit participants
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Virginia Commonwealth UniversityUniversity, hospital or other
- Study start
- Jan 2022 (estimated)
- Primary completion
- Dec 2022 (estimated)
- Study completion
- Dec 2022 (estimated)
- First posted
- 30 Apr 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| High fat | Experimental | Dietary Supplement: Boost VHCBoost VHC (Very High Calorie), Nestle, 8 ounce can |
| High protein | Experimental | Dietary Supplement: Ensure High ProteinEnsure High Protein 8 ounce can |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Boost VHC8 ounce can liquid meal, calories 530kcal, Carbohydrate 46g, Protein 22g, Fat 30g | Dietary supplement | High fat |
| Ensure High Protein8 ounce can liquid meal, calories 160kcal, Carbohydrate 13g, Protein 16g, Fat 2g | Dietary supplement | High protein |
Primary outcome
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.
4 secondary outcomes
glucose
Time frame: 16 hours after entry into metabolic chamber
insulin
Time frame: 16 hours after entry into metabolic chamber
Leptin
Time frame: 16 hours after entry into metabolic chamber
Ghrelin
Time frame: 16 hours after entry into metabolic chamber
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jan 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Trang Le, MD principal investigator
Virginia Commonwealth University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Boost VHC and Ensure High Protein in people with Cystic Fibrosis, run by Virginia Commonwealth University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 31 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Energy Expenditure (time frame: 16 hours after entry into metabolic chamber). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jan 2022.