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Almond Consumption and Glycemia

Almond Consumption and Glycemia

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03236116
Enrollment
75
Registered
2017-08-01
Start date
2017-08-01
Completion date
2020-12-31
Last updated
2021-01-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Brief summary

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

Detailed 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.

Interventions

OTHERAlmonds

Participants will consume almonds everyday for 6 months.

OTHERControl (no nuts)

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

Sponsors

Almond Board of California
CollaboratorOTHER
Purdue University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Homa-Percent BetaBaseline
C-peptidebaseline
Homa-IRbaseline
HbA1cBaselineHbA1c.
fasting glucoseBaselinefasting glucose,
Change in GLP-16 monthsGLP-1
fasting triglyceridesBaselinefasting triglycerides
Change in Body weightEvery two weeks for 6 months.Body weight
Body compositionBaselineBody composition
GLP-1BaselineGLP-1
Change in HbA1c6 monthsHbA1c.
Change in fasting glucose6 monthsfasting glucose
Change in Body composition6 monthsBody composition
fasting insulinBaselinefasting insulin
total cholesterolBaselinetotal cholesterol
LDL-cholesterolBaselineLDL-cholesterol
HDL-cholesterolBaselineHDL-cholesterol
GIPBaselineGIP
change in LDL-cholesterol6 monthsLDL-cholesterol
change in fasting insulin6 monthsfasting insulin
change in total cholesterol6 monthstotal cholesterol
change in HDL-cholesterol6 monthsHDL-cholesterol
change in GIP6 monthsGIP

Secondary

MeasureTime frameDescription
ComplianceBaseline, month 2, 4, and 6.Demonstrate the utility of a novel, sensitive approach to document compliance with a prescription to ingest almonds on a daily basis for six months.
Diet QualityThree days (two non-consecutive week days and one weekend day) at baseline, month 2, 4, and 6.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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026