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Tree Nut Consumption to Reduce Abdominal Adiposity

NCT ID: NCT03969264

Last Updated: 2023-12-05

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

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

84 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-07-15

Study Completion Date

2023-06-30

Brief Summary

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A major contributing factor to the rising waist circumference of U.S. young adults is the increase in snacking behavior. Both the frequency of snacking during the day and the percentage of adults who engage in snacking has risen; national data indicates snacking comprises 15-25% of the total daily caloric intake of young and middle-aged adults. The overarching hypothesis, based on significant preliminary data, is that the quantity and metabolic function of abdominal fat is a key intermediary factor by which greater tree nut consumption reduces ectopic lipid storage (including the accumulation of intra-abdominal \[visceral\] fat), improves fatty acid and lipoprotein metabolism, reduces systemic inflammation and insulin resistance, and thus, reduces risk for MetS in millennial-generation age individuals.

Detailed Description

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A major contributing factor to the rising waist circumference of U.S. young adults is the increase in snacking behavior. Both the frequency of snacking during the day and the percentage of adults who engage in snacking has risen; national data indicates snacking comprises 15-25% of the total daily caloric intake of young and middle-aged adults. Unfortunately, current typical snack items are energy rich, providing high intake of carbohydrates and sugars, as opposed to nuts that are nutrient rich. In prior work with middle-aged adults, the investigators found that consuming tree nuts daily as between-meal snacks for a period of 16 weeks significantly reduced intra-abdominal (visceral) fat and waist circumference, which was associated with altered plasma fatty acid profiles and higher fatty acid oxidation rates. Based on prior findings, the investigators propose to determine whether consuming mixed tree nuts as replacement for typical high carbohydrate snacks reduces abdominal obesity and waist circumference in millennials at risk for MetS. The overarching hypothesis, based on significant preliminary data, is that the quantity and metabolic function of abdominal fat is a key intermediary factor by which greater tree nut consumption reduces ectopic lipid storage (including the accumulation of intra-abdominal \[visceral\] fat), improves fatty acid and lipoprotein metabolism, reduces systemic inflammation and insulin resistance, and thus, reduces risk for MetS in millennial-generation age individuals. The hypothesis will be tested by determining: 1) the effect of consuming mixed tree nuts as daily snacks for 16 weeks on waist circumference and the quantity of abdominal fat (subcutaneous and visceral fat); 2) the effect of consuming mixed tree nuts as daily snacks for 16 weeks on circulating fatty acid profiles, glucose tolerance and insulin resistance, circulating lipids and lipoproteins, and circulating markers of inflammation; and 3) the effect of consuming mixed tree nuts as daily snacks for 16 weeks on abdominal tissue expression of genes that regulate inflammation, insulin resistance, and cardiometabolic mediators of MetS risk.

Conditions

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Millenials Risk for Metabolic Syndrome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Randomized parallel two-arm study.
Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Investigators Outcome Assessors
Investigator and research assistant are blinded to study intervention.

Study Groups

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Carb Snacks

Will follow study diet based on the Dietary Guidelines and consume study carbohydrate snacks between meals.

Group Type ACTIVE_COMPARATOR

High Carbohydrate or Tree Nut Food Snacks

Intervention Type OTHER

Snack consumption

Tree Nut Snacks

Will follow study diet based on the Dietary Guidelines and consume study tree nut snacks between meals.

Group Type EXPERIMENTAL

High Carbohydrate or Tree Nut Food Snacks

Intervention Type OTHER

Snack consumption

Interventions

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High Carbohydrate or Tree Nut Food Snacks

Snack consumption

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Age 22-36 years
* BMI 18.5 to 34.9
* At least one risk factor for metabolic syndrome based on waist circumference, HDL level or triglyceride level

Exclusion Criteria

* Tree nut allergy
* Diagnosed chronic disease
* Medication for dyslipidemia or hypertension
* Smoke
* Weight loss medication
* Narcotic medication or illicit drug use
* Pregnancy or lactation or postmenopausal
Minimum Eligible Age

22 Years

Maximum Eligible Age

36 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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International Tree Nut Council Research and Education Foundation

UNKNOWN

Sponsor Role collaborator

Vanderbilt University Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Heidi J. Silver

Research Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Heidi Silver, PhD

Role: PRINCIPAL_INVESTIGATOR

Vanderbilt University Medical Center

Locations

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Vanderbilt University Medical Center

Nashville, Tennessee, United States

Site Status

Countries

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United States

References

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Widmer A, Lillegard K, Wood K, Robles M, Fan R, Ye F, Koethe JR, Silver HJ. Consumption of tree nuts as snacks stimulates changes in plasma fatty acid profiles and adipose tissue gene expression in young adults at risk for metabolic syndrome. Clin Nutr. 2025 May;48:25-34. doi: 10.1016/j.clnu.2025.03.002. Epub 2025 Mar 8.

Reference Type DERIVED
PMID: 40117963 (View on PubMed)

Other Identifiers

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VUMC71426

Identifier Type: -

Identifier Source: org_study_id