NCT03064347

Targeted Enteral Nutrient Delivery: A Prospective Randomized Study

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 19 (actual)
• Sponsor: University of Southern California · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

This study will evaluate whether enteric-coated nutrients increase some glucose and regulating hormone levels, glucose tolerance and satiety in overweight and obese individuals with type 2 diabetes.

Detailed description

Direct delivery of nutrient to the upper intestine by enteral feeding tube can increase circulating levels of some glucose and appetite regulating hormones when compared to usual oral ingestion. Such an enhancement could be of value in the management of type 2 diabetes and obesity. In this study enteric-coated nutrients will be ingested to allow for direct delivery of nutrient to the upper intestine. Levels of select hormones and glucose, and measures of satiety and adverse effects will be compared following the ingestion of uncoated and enteric coated nutrient.

Conditions

• Diabetes Mellitus, Type 2

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	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.
DIETARY_SUPPLEMENT	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.
DIETARY_SUPPLEMENT	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.
DIETARY_SUPPLEMENT	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.
DIETARY_SUPPLEMENT	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.
DIETARY_SUPPLEMENT	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.
DIETARY_SUPPLEMENT	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.
DIETARY_SUPPLEMENT	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.

Timeline

• Start date: 2017-02-22
• Primary completion: 2018-06-20
• Completion: 2018-06-20
• First posted: 2017-02-27
• Last updated: 2019-06-18

Locations

1 site across 1 country: United States