Targeted Enteral Nutrient Delivery: A Prospective Randomized Study
NCT ID: NCT03064347
Last Updated: 2019-06-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
19 participants
INTERVENTIONAL
2017-02-22
2018-06-20
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
BASIC_SCIENCE
SINGLE
Study Groups
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Coated Sucrose plus Whole Milk
200kcal sucrose plus whole milk powder in enteric coating as single dose
Sucrose plus Whole Milk Powder in Enteric Coating
Single dose enteric coated sucrose plus whole milk powder will be consumed by mouth. Blood will be drawn at baseline and then at 15 minute intervals for 3 hours from ingestion for measurement of GLP-1, PYY, C-peptide, insulin and glucose.Visual analog score will be used to record satiety and adverse symptoms every 15 minutes.
Non Coated Sucrose plus Whole Milk
200kcal sucrose plus whole milk powder with separate enteric coating materials as single dose
Non coated Sucrose plus Whole Milk
Single dose sucrose plus whole milk powder with separate enteric coating materials will be consumed by mouth. Blood will be drawn at baseline and then at 15 minute intervals for 3 hours from ingestion for measurement of GLP-1, PYY, C-peptide, insulin and glucose.Visual analog score will be used to record satiety and adverse symptoms every 15 minutes.
Enteric Coated Sucrose
200kcal sucrose in enteric coating as single dose
Sucrose in Enteric Coating
Single dose enteric coated sucrose will be consumed by mouth. Blood will be drawn at baseline and then at 15 minute intervals for 3 hours from ingestion for measurement of GLP-1, PYY, C-peptide, insulin and glucose.Visual analog score will be used to record satiety and adverse symptoms every 15 minutes.
Non-Enteric Coated Sucrose
200kcal sucrose with separate enteric coating materials as single dose
Sucrose with Separate Enteric Coating Materials
Single dose sucrose with separate enteric coating materials will be consumed by mouth. Blood will be drawn at baseline and then at 15 minute intervals for 3 hours from ingestion for measurement of GLP-1, PYY, C-peptide, insulin and glucose.Visual analog score will be used to record satiety and adverse symptoms every 15 minutes.
Enteric Coated Whey Protein
200kcal whey protein in enteric coating as single dose
Whey Protein in Enteric Coating
Single dose enteric coated whey protein will be consumed by mouth. Blood will be drawn at baseline and then at 15 minute intervals for 3 hours from ingestion for measurement of GLP-1, PYY, C-peptide, insulin and glucose.Visual analog score will be used to record satiety and adverse symptoms every 15 minutes.
Non-Enteric Coated Whey Protein
200kcal whey protein with separate enteric coating materials as single dose
Whey Protein with Separate Enteric Coating Materials
Single dose whey protein with separate enteric coating materials will be consumed by mouth. Blood will be drawn at baseline and then at 15 minute intervals for 3 hours from ingestion for measurement of GLP-1, PYY, C-peptide, insulin and glucose.Visual analog score will be used to record satiety and adverse symptoms every 15 minutes.
Enteric Coated Pea Protein
200kcal pea protein in enteric coating as single dose
Pea Protein in Enteric Coating
Single dose enteric coated pea protein will be consumed by mouth. Blood will be drawn at baseline and then at 15 minute intervals for 3 hours from ingestion for measurement of GLP-1, PYY, C-peptide, insulin and glucose.Visual analog score will be used to record satiety and adverse symptoms every 15 minutes.
Non-Enteric Coated Pea Protein
200kcal pea protein with separate enteric coating materials as single dose
Pea Protein with Separate Enteric Coating Materials
Single dose pea protein with separate enteric coating materials will be consumed by mouth. Blood will be drawn at baseline and then at 15 minute intervals for 3 hours from ingestion for measurement of GLP-1, PYY, C-peptide, insulin and glucose.Visual analog score will be used to record satiety and adverse symptoms every 15 minutes.
Interventions
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Sucrose plus Whole Milk Powder in Enteric Coating
Single dose enteric coated sucrose plus whole milk powder will be consumed by mouth. Blood will be drawn at baseline and then at 15 minute intervals for 3 hours from ingestion for measurement of GLP-1, PYY, C-peptide, insulin and glucose.Visual analog score will be used to record satiety and adverse symptoms every 15 minutes.
Non coated Sucrose plus Whole Milk
Single dose sucrose plus whole milk powder with separate enteric coating materials will be consumed by mouth. Blood will be drawn at baseline and then at 15 minute intervals for 3 hours from ingestion for measurement of GLP-1, PYY, C-peptide, insulin and glucose.Visual analog score will be used to record satiety and adverse symptoms every 15 minutes.
Sucrose in Enteric Coating
Single dose enteric coated sucrose will be consumed by mouth. Blood will be drawn at baseline and then at 15 minute intervals for 3 hours from ingestion for measurement of GLP-1, PYY, C-peptide, insulin and glucose.Visual analog score will be used to record satiety and adverse symptoms every 15 minutes.
Sucrose with Separate Enteric Coating Materials
Single dose sucrose with separate enteric coating materials will be consumed by mouth. Blood will be drawn at baseline and then at 15 minute intervals for 3 hours from ingestion for measurement of GLP-1, PYY, C-peptide, insulin and glucose.Visual analog score will be used to record satiety and adverse symptoms every 15 minutes.
Whey Protein in Enteric Coating
Single dose enteric coated whey protein will be consumed by mouth. Blood will be drawn at baseline and then at 15 minute intervals for 3 hours from ingestion for measurement of GLP-1, PYY, C-peptide, insulin and glucose.Visual analog score will be used to record satiety and adverse symptoms every 15 minutes.
Whey Protein with Separate Enteric Coating Materials
Single dose whey protein with separate enteric coating materials will be consumed by mouth. Blood will be drawn at baseline and then at 15 minute intervals for 3 hours from ingestion for measurement of GLP-1, PYY, C-peptide, insulin and glucose.Visual analog score will be used to record satiety and adverse symptoms every 15 minutes.
Pea Protein in Enteric Coating
Single dose enteric coated pea protein will be consumed by mouth. Blood will be drawn at baseline and then at 15 minute intervals for 3 hours from ingestion for measurement of GLP-1, PYY, C-peptide, insulin and glucose.Visual analog score will be used to record satiety and adverse symptoms every 15 minutes.
Pea Protein with Separate Enteric Coating Materials
Single dose pea protein with separate enteric coating materials will be consumed by mouth. Blood will be drawn at baseline and then at 15 minute intervals for 3 hours from ingestion for measurement of GLP-1, PYY, C-peptide, insulin and glucose.Visual analog score will be used to record satiety and adverse symptoms every 15 minutes.
Eligibility Criteria
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Inclusion Criteria
* BMI \>27kg/m2
* Type 2 diabetes with known duration of \<10years
* On metformin, sulfonylureas, thiazolidinedione or SGLT2 inhibitor or lifestyle management alone or in combination only for management of type 2 diabetes
Exclusion Criteria
* Known foregut pathology or prior foregut surgery.
* Previous surgical treatment for obesity (excluding liposuction if performed \> one year before trial entry)
* Known cardiovascular disease other than controlled hypertension
* Known proliferative retinopathy or maculopathy requiring acute treatment, as judged by the Investigator
* Known untreated or uncontrolled hypothyroidism/hyperthyroidism
* History of chronic pancreatitis or idiopathic acute pancreatitis
* Obesity induced by other endocrinologic disorders (e.g. Cushing Syndrome)
* Cancer (past or present except basal cell skin cancer or squamous cell skin cancer), which in the Investigator's opinion could interfere with the results of the trial
* Use of insulin, DPP4 inhibitors or GLP-1 analogs in the previous 1 month
* Treatment with any antidiabetic agent(s) other than metformin, sulphonylurea thiazolidinedione or SGLT-2 inhibitors in the 1 month prior to screening
* Use of any drug (except for metformin, sulphonylurea or thiazolidinedione or SGLT-2 inhibitors), which in the Investigator's opinion could interfere with glucose level (e.g. systemic corticosteroids)
* Receipt of any other anti-diabetic investigational drug within 1 month prior to screening for this trial, or receipt of any investigational drugs not affecting diabetes within 1 month prior to screening for this trial
* Current or history of treatment with medications that may cause significant weight gain, within 1 month prior to screening for this trial, including systemic corticosteroids (except for a short course of treatment, i.e., 7- 10 days), tri-cyclic antidepressants, atypical antipsychotic and mood stabilizers (e.g., imipramine, amitryptiline, mirtazapin, paroxetine, phenelzine, clorpromazine, olanzapine,valproic acid and its derivatives, and lithium) thioridazine, clozapine,
* Currently using or have used within three months prior to screening for this trial: pramlintide, sibutramine, orlistat, zonisamide, topiramate or phenteremine (either by prescription or as part of a clinical trial)
* Simultaneous participation in any other clinical trial of an investigational drug
* The receipt of any investigational product within four weeks prior to screening for this trial Herbal supplements or over-the-counter medications
* Diet attempts using herbal supplements or over-the-counter medications within 1 month prior to screening into this trial Other
* Milk allergy
* Lactose intolerance Language barrier, mental incapacity, unwillingness or inability to understand and be able to complete the study Females of childbearing potential
* Pregnant breast-feeding or intend to become pregnant or are not using adequate contraceptive methods (adequate contraceptive measures as required by US: abstinence and the following methods: diaphragm with spermacide, condom with spermacide (by male partner), intrauterine device, sponge, spermacide, Norplant®, Depo-Provera® or oral contraceptives.
18 Years
65 Years
ALL
No
Sponsors
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University of Southern California
OTHER
Responsible Party
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Elizabeth Beale
Assistant Professor
Principal Investigators
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Elizabeth Beale, MD
Role: PRINCIPAL_INVESTIGATOR
University of Southern California, Keck School of Medicine
Locations
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USC Diabetes & Obesity Research Institute (DORI)
Los Angeles, California, United States
Countries
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Other Identifiers
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TEND HS-16-00339
Identifier Type: -
Identifier Source: org_study_id
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