Skip to content

Tree Nut Consumption to Reduce Abdominal Adiposity

Tree Nut Consumption to Reduce Abdominal Adiposity and Risk for Metabolic Syndrome in Millennials

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03969264
Enrollment
84
Registered
2019-05-31
Start date
2019-07-15
Completion date
2023-06-30
Last updated
2023-12-05

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

Conditions

Millenials, Risk for Metabolic Syndrome

Brief summary

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

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.

Interventions

OTHERHigh Carbohydrate or Tree Nut Food Snacks

Snack consumption

Sponsors

International Tree Nut Council Research and Education Foundation
CollaboratorUNKNOWN
Vanderbilt University Medical Center
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Investigator, Outcomes Assessor)

Masking description

Investigator and research assistant are blinded to study intervention.

Intervention model description

Randomized parallel two-arm study.

Eligibility

Sex/Gender
ALL
Age
22 Years to 36 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Waist circumference18 weeksChange in waist circumference (in centimeters)
Visceral Fat18 weeksChange in quantity of intra-abdominal fat by CT scan

Secondary

MeasureTime frameDescription
Dietary Macronutrient Intake18 weeksChange in macronutrient composition of the diet
Gene Expression in Adipose Tissue18 weeksChange in expression of genes involved in regulation of inflammation and insulin resistance
Insulin18 weeksChange in serum insulin (mg/dl)
Glucose18 weeksChange in fasting blood glucose (mg/dl)
Inflammation18 weeksChange in CRP level (mg/dl)

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 5, 2026