Almond Consumption and Glycemia

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

75 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-08-01

Study Completion Date

2020-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Cephalic Phase Responses to Nutritive and Non-Nutritive Sweeteners

NCT06387316

Pre Diabetes

ACTIVE_NOT_RECRUITING NA

The Chocolate Almond Study - Relating Chewing to Satiation and Postprandial Response

NCT07065461

Satiation, Satiety Postprandial Glycemia Postprandial Lipemia

RECRUITING NA

WHNRC (Western Human Nutrition Research Center) Honey Study

NCT06107231

Postprandial Glycemia Metabolic Stress Cognitive Change +1 more

ACTIVE_NOT_RECRUITING NA

The Effects of Aspartame on Appetite, Body Composition and Oral Glucose Tolerance

NCT02999321

Oral Glucose Tolerance

COMPLETED NA

Glycaemic Response to a Liquid Meal Tolerance Test

NCT01682174

Glycaemic Index Glycaemic Response

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Glucose Intolerance Appetite Disorders Glucose Metabolism Disorders (Including Diabetes Mellitus) Lipid Metabolism Disorder

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Almond Group

Participants will consumed almonds every day for 6 months, but will not be allowed to consume any other nuts or nut products.

Group Type EXPERIMENTAL

Almonds

Intervention Type OTHER

Participants will consume almonds everyday for 6 months.

Control Group

Participants will continue with their normal eating routine for 6 months, but will not be allowed to consume any nuts or nut products.

Group Type EXPERIMENTAL

Control (no nuts)

Intervention Type OTHER

Participants will not be permited to consume any nuts for 6 months.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Almonds

Participants will consume almonds everyday for 6 months.

Intervention Type OTHER

Control (no nuts)

Participants will not be permited to consume any nuts for 6 months.

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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