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Almond Effects on Glucose Intolerance Study

NCT02260895 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2024-03-20

No results posted yet for this study

Summary

Diabetes is a major cause of morbidity and mortality worldwide. Prevention of diabetes is an important goal. The progression from impaired glucose tolerance to diabetes is thought to be promoted by the toxic effects of hyperglycemia on pancreatic beta cells. One of the main defects causing postprandial hyperglycemia in individuals with impaired glucose tolerance is reduced first phase (immediate) insulin release. The investigators hypothesis is that consuming a nutritional preload--a low-calorie, nutritionally balanced snack--30 minutes before ingesting a carbohydrate load, will moderate the hyperglycemic response to subsequent carbohydrate challenge and reduce glucotoxicity by stimulating insulin release and synthesis.

The aim of this study is to test this hypothesis by comparing the standard 75-gram, two-hour oral glucose tolerance test (OGTT) response of 30 fasting adults who have impaired glucose tolerance to their OGTT response when the test is preceded by ½ ounce (14 grams) of dry-roasted, unsalted almonds. A pre-load interval of 30 minutes was chosen so that the peak of phase 2 (delayed) insulin response to the pre-load (45-60 minutes) would coincide with the timeframe of the steepest OGTT rise in glucose (15 to 30 minutes post challenge).

The investigators hypothesize that the one-hour OGTT glucose level will be approximately 40 mg/dl lower when participants consume the pre-OGTT almond snack, compared to their one-hour glucose level on the standard two-hour OGTT. The two-hour OGTT glucose level is unlikely to show a statistically significant difference between the almond pre-test snack and control standard OGTT conditions.

Conditions

Interventions

DIETARY_SUPPLEMENT

Almond pre-test snack

unsalted, dry-roasted almonds, 1/2 oz (14 g), ingested 30 minutes prior to the start of a two-hour oral glucose tolerance test

Sponsors & Collaborators

  • Memorial Hermann Health System

    lead OTHER

Principal Investigators

  • Michael A Crouch, MD, MSPH · Memorial Hermann Health System

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2014-12-31
Primary Completion
2016-07-31
Completion
2016-07-31

Countries

  • United States

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02260895 on ClinicalTrials.gov