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OpenTrials
Completed

NCT Number: NCT03969264

Tree Nut Consumption to Reduce Abdominal Adiposity

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.

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Key information

Age range

22 year–36 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Vanderbilt University Medical Center

Nashville, Tennessee, 37232, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

High Carbohydrate or Tree Nut Food Snacks

Other

Snack consumption

Primary outcomes

  1. Waist circumference

    Time frame: 18 weeks

    Change in waist circumference (in centimeters)

  2. Visceral Fat

    Time frame: 18 weeks

    Change in quantity of intra-abdominal fat by CT scan

Secondary outcomes

  1. Gene Expression in Adipose Tissue

    Time frame: 18 weeks

    Change in expression of genes involved in regulation of inflammation and insulin resistance

  2. Inflammation

    Time frame: 18 weeks

    Change in CRP level (mg/dl)

  3. Dietary Macronutrient Intake

    Time frame: 18 weeks

    Change in macronutrient composition of the diet

  4. Glucose

    Time frame: 18 weeks

    Change in fasting blood glucose (mg/dl)

  5. Insulin

    Time frame: 18 weeks

    Change in serum insulin (mg/dl)

Sponsors and collaborators

Lead sponsor

Vanderbilt University Medical Center

Other

Collaborators

  • International Tree Nut Council Research and Education Foundation

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2023
Study completion
2023
First posted
May 31, 2019
Registry last updated
Dec 5, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.