Almond Consumption and Glycemia

Glucose Intolerance Clinical Trial

Official title:

Almond Consumption and Glycemia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03236116
• Other study ID #: 055-047
• Status: Completed
• Phase: N/A
• Start date: August 1, 2017
• Est. completion date: December 31, 2020

Study information

• Verified date: January 2021
• Source: Purdue University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study will examine the effects of almonds consumed by adults with different body fat distributions on indices of carbohydrate and lipid metabolism.

Description:

There is considerable evidence supporting a causal role for truncal visceral fat depots in glucose dysregulation. Individuals with large visceral fat depots have impaired suppression of free fatty acid release in response to insulin, elevated triglycerides and low concentrations of high density lipoprotein cholesterol. The high free fatty acid concentration may induce insulin resistance in the muscle and liver. There is more recent evidence that truncal subcutaneous fat depots are also problematic, though this literature is mixed. In contrast, gluteo-femoral fat depots have not been implicated in insulin resistance and dysregulation of carbohydrate metabolism. Failure to account for differences in the contributions of these depots will add noise to measurements of dietary interventions to mitigate glucose dysregulation. Previous studies have reported evidence indicating acute and chronic consumption of almonds improves glycemia. Acute effects are important indicators of health benefit, but longer-term trials, ones permitting identification of the effects of a dietary intervention on HbA1c, are more telling and clinically relevant. To more definitively establish the association between almond consumption and improved carbohydrate metabolism, we propose a six-month trial that contrasts the effects of almond consumption at optimal times of the day versus consumption of low nutrient dense snack foods on indices of carbohydrate metabolism, food intake and appetite in adults characterized by three distinct fat depots. Participants will consume either almonds, or no nuts every day for 6 months. At baseline, participants will be weighed and undergo a DEXA scan to determine body fat composition and will be assigned a group. Blood will also be collected fasted and at stipulated times in response to a meal tolerance test to measure insulin, glucose, C-peptide, HbA1c, lipid panel, gut peptides, and compliance to the diet. Participants will be given links to complete appetite ratings and record food intake. Participants will report to the lab every two weeks to be weighed, and get a resupply of almonds (if in the almond group). At the two-week mark on months 2 and 4, participants will be weighed, blood will be taken to assess compliance to the diet, and links will be given to complete appetite ratings and record food intake. At month 6, all measurements from baseline will be repeated.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 75
• Est. completion date: December 31, 2020
• Est. primary completion date: March 20, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

Inclusion Criteria:

• Meeting one of the following body fat distribution criteria determined by DEXA: 1. High visceral fat 2. High gluteo-femoral fat 3. High truncal subcutaneous fat
• 18-60 years
• no nut allergies

Exclusion Criteria:

• Not meeting one of the body fat distribution criteria
• allergic to nuts

Related Conditions & MeSH terms

• Appetite Disorders
• Disease
• Feeding and Eating Disorders
• Glucose Intolerance
• Glucose Metabolism Disorders
• Glucose Metabolism Disorders (Including Diabetes Mellitus)
• Lipid Metabolism Disorder
• Lipid Metabolism Disorders
• Metabolic Diseases

Intervention

Other:
• Almonds
Participants will consume almonds everyday for 6 months.
• Control (no nuts)
Participants will not be permited to consume any nuts for 6 months.

Locations

Country	Name	City	State
United States	Indiana University School of Medicine	Indianapolis	Indiana
United States	Purdue University	West Lafayette	Indiana
United States	Purdue University	West Lafayette	Indiana

Sponsors (2)

Lead Sponsor	Collaborator
Purdue University	Almond Board of California

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	HbA1c	HbA1c.	Baseline
Primary	fasting glucose	fasting glucose,	Baseline
Primary	fasting triglycerides	fasting triglycerides	Baseline
Primary	Change in Body weight	Body weight	Every two weeks for 6 months.
Primary	Body composition	Body composition	Baseline
Primary	GLP-1	GLP-1	Baseline
Primary	Change in HbA1c	HbA1c.	6 months
Primary	Change in fasting glucose	fasting glucose	6 months
Primary	fasting triglycerides	fasting triglycerides	6 months
Primary	Change in Body composition	Body composition	6 months
Primary	Change in GLP-1	GLP-1	6 months
Primary	fasting insulin	fasting insulin	Baseline
Primary	total cholesterol	total cholesterol	Baseline
Primary	LDL-cholesterol	LDL-cholesterol	Baseline
Primary	HDL-cholesterol	HDL-cholesterol	Baseline
Primary	GIP	GIP	Baseline
Primary	change in fasting insulin	fasting insulin	6 months
Primary	change in total cholesterol	total cholesterol	6 months
Primary	change in LDL-cholesterol	LDL-cholesterol	6 months
Primary	change in HDL-cholesterol	HDL-cholesterol	6 months
Primary	change in GIP	GIP	6 months
Primary	C-peptide		baseline
Primary	C-peptide		6 months
Primary	Homa-IR		baseline
Primary	Homa-IR		6 months
Primary	Homa-Percent Beta		Baseline
Primary	Homa-Percent Beta		6 months
Secondary	Diet Quality	Determine the effect of substituting a wholesome snack food (almonds) for more traditional, less nutrient dense, snack foods on total diet quality. Food intake will be measured by the ASA-24 for three days (two non-consecutive week days and one weekend day) at baseline, month 2, 4, and 6.	Three days (two non-consecutive week days and one weekend day) at baseline, month 2, 4, and 6.
Secondary	Compliance	Demonstrate the utility of a novel, sensitive approach to document compliance with a prescription to ingest almonds on a daily basis for six months.	Baseline, month 2, 4, and 6.