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
About this trial
This is an interventional prevention trial for Millenials
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
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
NCT ID
NCT03969264
First Posted
May 23, 2019
Last Updated
July 17, 2023
Sponsor
Vanderbilt University Medical Center
Collaborators
International Tree Nut Council Research and Education Foundation
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
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