search
Back to results

Tree Nut Consumption to Reduce Abdominal Adiposity

Primary Purpose

Millenials, Risk for Metabolic Syndrome

Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
High Carbohydrate or Tree Nut Food Snacks
Sponsored by
Vanderbilt University Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Millenials

Eligibility Criteria

22 Years - 36 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Vanderbilt University Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Carb Snacks

Tree Nut Snacks

Arm Description

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

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

Outcomes

Primary Outcome Measures

Waist circumference
Change in waist circumference (in centimeters)
Visceral Fat
Change in quantity of intra-abdominal fat by CT scan

Secondary Outcome Measures

Gene Expression in Adipose Tissue
Change in expression of genes involved in regulation of inflammation and insulin resistance
Inflammation
Change in CRP level (mg/dl)
Dietary Macronutrient Intake
Change in macronutrient composition of the diet
Glucose
Change in fasting blood glucose (mg/dl)
Insulin
Change in serum insulin (mg/dl)

Full Information

First Posted
May 23, 2019
Last Updated
July 17, 2023
Sponsor
Vanderbilt University Medical Center
Collaborators
International Tree Nut Council Research and Education Foundation
search

1. Study Identification

Unique Protocol Identification Number
NCT03969264
Brief Title
Tree Nut Consumption to Reduce Abdominal Adiposity
Official Title
Tree Nut Consumption to Reduce Abdominal Adiposity and Risk for Metabolic Syndrome in Millennials
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
July 15, 2019 (Actual)
Primary Completion Date
December 30, 2023 (Anticipated)
Study Completion Date
December 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Vanderbilt University Medical Center
Collaborators
International Tree Nut Council Research and Education Foundation

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Millenials, Risk for Metabolic Syndrome

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomized parallel two-arm study.
Masking
InvestigatorOutcomes Assessor
Masking Description
Investigator and research assistant are blinded to study intervention.
Allocation
Randomized
Enrollment
112 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Carb Snacks
Arm Type
Active Comparator
Arm Description
Will follow study diet based on the Dietary Guidelines and consume study carbohydrate snacks between meals.
Arm Title
Tree Nut Snacks
Arm Type
Experimental
Arm Description
Will follow study diet based on the Dietary Guidelines and consume study tree nut snacks between meals.
Intervention Type
Other
Intervention Name(s)
High Carbohydrate or Tree Nut Food Snacks
Intervention Description
Snack consumption
Primary Outcome Measure Information:
Title
Waist circumference
Description
Change in waist circumference (in centimeters)
Time Frame
18 weeks
Title
Visceral Fat
Description
Change in quantity of intra-abdominal fat by CT scan
Time Frame
18 weeks
Secondary Outcome Measure Information:
Title
Gene Expression in Adipose Tissue
Description
Change in expression of genes involved in regulation of inflammation and insulin resistance
Time Frame
18 weeks
Title
Inflammation
Description
Change in CRP level (mg/dl)
Time Frame
18 weeks
Title
Dietary Macronutrient Intake
Description
Change in macronutrient composition of the diet
Time Frame
18 weeks
Title
Glucose
Description
Change in fasting blood glucose (mg/dl)
Time Frame
18 weeks
Title
Insulin
Description
Change in serum insulin (mg/dl)
Time Frame
18 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
22 Years
Maximum Age & Unit of Time
36 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Heidi Silver, PhD
Organizational Affiliation
Vanderbilt University Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Vanderbilt University Medical Center
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
No current plan to share IPD with other researchers.

Learn more about this trial

Tree Nut Consumption to Reduce Abdominal Adiposity

We'll reach out to this number within 24 hrs