Clinical Trials Logo

Clinical Trial Summary

The purpose of this study is to determine insulin sensitivity in individuals that are lean normal glucose tolerant subjects after consumption of a normal low fat diet and after a high fat diet and to explore the effects of high fat consumption on the intestinal microbiome, and metabolic endotoxemia.( Aim 1 of the protocol, a separate record is available for Aim 2)


Clinical Trial Description

We will test the hypothesis that a high fat diet given to lean, normal glucose tolerant subjects will impair insulin signaling and sensitivity and modify gut microbiome composition and enhance intestinal permeability, which will increase plasma LPS concentration, induce an inflammatory response in peripheral tissues (skeletal muscle). Also we will test the hypothesis that the inflammatory response and insulin resistance caused by high fat ingestion can be ameliorated by administering - a synbiotic (Bifidobacterium longum R0175 and oligofructose) which protects the intestinal epithelial barrier and decreases intestinal translocation of LPS; and - sevelamer, an agent which sequesters lipopolysaccharide (LPS) in the gastrointestinal tract limiting its translocation into the circulation. All subjects are fed both a low fat diet (considered a normal diet) and high fat diet, first one and then the other in no particular sequence. After a washout period participants are fed the other type of high or low fat diet, depending on which diet they were first assigned to in order to compare the effects of the intervention on insulin sensitivity during each diet. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT02124759
Study type Interventional
Source The University of Texas Health Science Center at San Antonio
Contact
Status Completed
Phase Phase 2
Start date April 2, 2014
Completion date March 30, 2020

See also
  Status Clinical Trial Phase
Completed NCT03458741 - How is Glycogen Supercompensation Regulated in Human Skeletal Muscle N/A
Recruiting NCT06042517 - Mechanisms of Ultrasound Neuromodulation Effects in Diabetes N/A
Completed NCT03859934 - Metabolic Effects of Melatonin Treatment Phase 1
Completed NCT03689738 - Effects of Potato Resistant Starch Intake on Insulin Sensitivity, Related Metabolic Markers and Satiety N/A
Recruiting NCT04195165 - The Effect of Sitting and Moderate Exercise on Plasma Insulin and Glucose Responses to an Oral Glucose Tolerance Test N/A
Recruiting NCT05441982 - Saccharin and Acesulfame Potassium Consumption and Glucose Homeostasis in Older Adults With Prediabetes N/A
Terminated NCT03325933 - Resistance Training and Cardiometabolic Health N/A
Recruiting NCT05791968 - Blood Donation Could Improve Insulin Sensitivity N/A
Completed NCT02700698 - Mitochondrial Function in Circulating Cells and Muscle Tissue
Completed NCT02913079 - The Acute Impact of Sit-stand Desks on Post-meal Blood Sugar Levels N/A
Suspended NCT03240978 - Exercise Intervention for the Prevention of Prediabetes in Overweight Chinese N/A
Recruiting NCT01972113 - Vitamin K and Glucose Metabolism in Children at Risk for Diabetes (Vita-K 'n' Kids Study) N/A
Completed NCT02058914 - Effects of Sugar Sweetened Beverage on Metabolic Health in Male and Female Adolescents N/A
Enrolling by invitation NCT02192684 - Obesity, Sleep Apnea, and Insulin Resistance N/A
Completed NCT00936130 - Bariatric Surgery and Weight Loss on Energy Metabolism and Insulin Sensitivity N/A
Completed NCT01216956 - Metabolic Effects of an 8 Week Niaspan Treatment in Patients With Abdominal Obesity and Mixed Dyslipidemia N/A
Recruiting NCT05992688 - The Sweet Kids Study (Stevia on Weight and Energy Effect Over Time) N/A
Recruiting NCT04168372 - Fructose: Substrate, Stimulus, or Both? N/A
Recruiting NCT05443347 - Activity, Adiposity, and Appetite in Adolescents 2 Intervention N/A
Terminated NCT04239482 - Nutritional Supplementation and Insulin Sensitivity N/A