Almond Effects on Glucose Intolerance Study

NCT02260895 | Terminated

• 1 other identifier: HSC-MH-14-0667
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief 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

Prediabetes

Outcome Measures

Primary Outcomes (1)

• One-hour OGTT result

  One-hour oral glucose tolerance test result

  60 minutes into 2-hour oral glucose tolerance test

Secondary Outcomes (1)

• Two-hour OGTT result

  120 minutes into 2-hour oral glucose tolerance test

Study Arms (2)

Control

NO INTERVENTION

Standard 2-hour 75-gram oral glucose tolerance test

Almond Pre-test snack

EXPERIMENTAL

1/2 ounce (14 g) almond snack 30 minutes prior to a 2-hour 75-gram oral glucose tolerance test

Dietary Supplement: Almond pre-test snack

Interventions

Almond pre-test snack DIETARY_SUPPLEMENT

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

Also known as: unsalted, dry-roasted almonds

Almond Pre-test snack

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• History of abnormal 1-hour OGTT result (\>160 mg/dL) or 2-hour OGTT (\>140)

You may not qualify if:

• History of a diagnosis of diabetes
• History of a 2-hour OGTT result \>200 mg/dL
• History of a fasting glucose \>125 mg/dL

Sponsors & Collaborators

• Memorial Hermann Health System: lead

Study Sites (1)

Physicians at Sugar Creek - Memorial Family Medicine Residency Program

Sugar Land, Texas, 77478, United States

Location

MeSH Terms

Conditions

Prediabetic State

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Michael A Crouch, MD, MSPH

  Memorial Hermann Health System

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: AVP Research

Study Record Dates

• First Submitted: October 6, 2014
• First Posted: October 9, 2014
• Study Start: December 1, 2014
• Primary Completion: July 1, 2016
• Study Completion: July 1, 2016
• Last Updated: March 20, 2024

Record last verified: 2024-03

Locations

US (1)