NCT02020343

Brief Summary

America's preferential consumption of high-fat/high-sugar foods is a driving force in the current epidemic of obesity and insulin resistance. Recent scientific observations suggest that the taste of food may play a role in how the body processes the food eaten in a meal. The intestine may play a central role in all aspects of dietary fat metabolism, from initial encounter with taste buds in the mouth to eventual triglyceride (TG) storage in the body. The investigators hypothesize that elevated blood fats in insulin resistance are a result of elevated intestinal-TG secretion and poor communication of this organ to the rest of the body after meals. In this study, meal feeding and sensory studies will be performed to determine whether the mechanism of taste-associated intestinal signaling leads to higher levels of blood fats after meals in 24 healthy, insulin resistant and type 2 diabetic subjects. Individuals will consume special meals the night before the tests and participate in sensory tests in the morning to analyze the effect of taste. The goal of this work is to understand how insulin resistance may cause impaired signaling between the taste buds and the intestine to result in an elevation in blood lipids, which increases the risk for other chronic diseases. This study will generate data for a future study to understand how diabetes treatment affects this process.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
22

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jan 2014

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 13, 2013

Completed
11 days until next milestone

First Posted

Study publicly available on registry

December 24, 2013

Completed
8 days until next milestone

Study Start

First participant enrolled

January 1, 2014

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2016

Completed
Last Updated

August 19, 2016

Status Verified

August 1, 2016

Enrollment Period

2.6 years

First QC Date

December 13, 2013

Last Update Submit

August 17, 2016

Conditions

Insulin ResistanceType 2 Diabetes

Outcome Measures

Primary Outcomes (1)

  • Meal triglyceride (TG) absorption

    In vivo measurement of meal TG absorption is made using stable isotope administration into sequential meals (lunch and dinner) and analysis of plasma samples by GS/MS

    Change in plasma TG concentrations over 24 hr after meals and in response to an acute sensory stimulus

Study Arms (3)

Healthy

Not insulin resistant

Behavioral: taste tests

Insulin resistant

Insulin resistant by IVGTT

Behavioral: taste tests

Type 2 diabetics

Type 2 diabetics

Behavioral: taste tests

Interventions

taste testsBEHAVIORAL

Subjects undergo "sham feeding" in which they take a bit of food, chew it and spit it out. This test should engage sensory mechanisms which may affect intestinal signaling.

HealthyInsulin resistantType 2 diabetics

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Healthy, insulin resistant and type 2 diabetic subjects.

You may qualify if:

  • Healthy subjects (age 18-50y) will be categorized as:
  • lean/insulin sensitive (IS) (n=8, BMI \</= 24 kg/m2 and SI ≥ 2.5 min-1 10-4 \* per uU/mL)
  • overweight/obese IS (n=8, BMI 26-35 and SI \>2.5 min-1 10-4 \* per uU/mL)
  • overweight/obese insulin resistant (n=8, BMI 26-35 and SI \<2.5 min-1 10-4 \* per uU/mL).
  • Overweight/obese insulin resistant subjects will have a family history of diabetes as defined as at least one parent or grandparent with type 2 diabetes, or at least one other family member with type 2 diabetes.
  • Type 2 diabetic patients (BMI 26-35, and OGTT 2h glucose \>/= 140 mg/dL.

You may not qualify if:

  • BMI over 35 kg/m2: We felt it prudent to limit the additional variability that could be caused by morbid obesity (and by diabetes), given the early stages of this research area.
  • Unusual eating habits (dietary fat\< 30% or \>40% of energy, skipping breakfast, day-long fasting, or allergies to milk). Habitual food intake can influence taste acuity and milk is used in the formulas to dissolve the isotopes.
  • Uncontrolled hypertension, or occasional or regular smoker, use of supplements or medications that interfere with lipid, protein, or carbohydrate metabolism or impact taste. For example, the hypertensive drugs thiazides or the supplement chondroitin sulfate or niacin, can be associated with impaired glucose tolerance. ACE inhibitors and beta-blockers and smoking can affect taste. Use of insulin in the case of type 2 diabetics.
  • Pregnancy (urine test), breastfeeding, or anemia (CBC with diff): Limitations of blood that can be drawn. Postmenopausal women frequently have increases in blood lipids since lack of estrogen influences lipid metabolism.
  • Alcohol intake: Males \>140 g/week, females \> 70 g/week. Excess EtOH increases lipid synthesis and secretion in the liver and whether it also has an impact on intestinal TG metabolism is unknown.
  • Fasting plasma TG \>300 mg/dL. Extreme hypertriglyceridemia could be due to either elevations in VLDL or chylomicrons, either of which would impair our ability to resolve dietary metabolic processes.
  • Exclude those who need to consume acetaminophen-containing medications on a regular basis. Acetaminophen is administered with meals to assess gastric emptying.
  • Postmenopausal women.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Missouri

Columbia, Missouri, 65212, United States

Location

Related Publications (1)

  • Jacome-Sosa M, Hu Q, Manrique-Acevedo CM, Phair RD, Parks EJ. Human intestinal lipid storage through sequential meals reveals faster dinner appearance is associated with hyperlipidemia. JCI Insight. 2021 Aug 9;6(15):e148378. doi: 10.1172/jci.insight.148378.

    PMID: 34369385DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

DNA will be collected for future determination of genotypes that impact taste senstivity

MeSH Terms

Conditions

Insulin ResistanceDiabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

HyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesDiabetes MellitusEndocrine System Diseases

Study Officials

  • Elizabeth J Parks, PhD

    University of Missouri-Columbia

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

December 13, 2013

First Posted

December 24, 2013

Study Start

January 1, 2014

Primary Completion

August 1, 2016

Study Completion

August 1, 2016

Last Updated

August 19, 2016

Record last verified: 2016-08

Locations

US(1)