免费获得国外相关药品，最快 1 个工作日回馈药物信息

出境医 / 临床实验 / Tree Nut Consumption to Reduce Abdominal Adiposity

Tree Nut Consumption to Reduce Abdominal Adiposity

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.

Condition or disease Intervention/treatment Phase
Millenials Risk for Metabolic Syndrome Other: High Carbohydrate or Tree Nut Food Snacks Not Applicable

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.
Study Design
Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 112 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Randomized parallel two-arm study.
Masking: Double (Investigator, Outcomes Assessor)
Masking Description: Investigator and research assistant are blinded to study intervention.
Primary Purpose: Prevention
Official Title: Tree Nut Consumption to Reduce Abdominal Adiposity and Risk for Metabolic Syndrome in Millennials
Actual Study Start Date : July 15, 2019
Estimated Primary Completion Date : January 1, 2022
Estimated Study Completion Date : May 30, 2022
Arms and Interventions
Arm Intervention/treatment
Active Comparator: Carb Snacks
Will follow study diet based on the Dietary Guidelines and consume study carbohydrate snacks between meals.
 Other: High Carbohydrate or Tree Nut Food Snacks
Snack consumption
Experimental: Tree Nut Snacks
Will follow study diet based on the Dietary Guidelines and consume study tree nut snacks between meals.
 Other: High Carbohydrate or Tree Nut Food Snacks
Snack consumption
Outcome Measures
Primary Outcome Measures :
  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 Outcome Measures :
  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)


Eligibility Criteria
Layout table for eligibility information
Ages Eligible for Study:   22 Years to 36 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Age 22-36 years
  • BMI 18.5 to 29.9
  • 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
Contacts and Locations

Contacts
Layout table for location contacts
Contact: Heidi Silver, PhD 6158759355 heidi.j.silver@vumc.org
Contact: Dianna Olson, RD 6159360365 dianna.olson@vumc.org

Locations
Layout table for location information
United States, Tennessee
Vanderbilt University Medical Center Recruiting
Nashville, Tennessee, United States, 37232
Contact: Heidi J Silver, PhD    615-875-9355    heidi.j.silver@vumc.org   
Contact       heidi.j.silver@vanderbilt.edu   
Principal Investigator: Heidi J Silver, PhD         
Sponsors and Collaborators
Vanderbilt University Medical Center
International Tree Nut Council Research and Education Foundation
Investigators
Layout table for investigator information
Principal Investigator: Heidi Silver, PhD Vanderbilt University Medical Center
Tracking Information
First Submitted Date  ICMJE May 23, 2019
First Posted Date  ICMJE May 31, 2019
Last Update Posted Date November 10, 2020
Actual Study Start Date  ICMJE July 15, 2019
Estimated Primary Completion Date January 1, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 28, 2019)
  • Waist circumference [ Time Frame: 18 weeks ]
    Change in waist circumference (in centimeters)
  • Visceral Fat [ Time Frame: 18 weeks ]
    Change in quantity of intra-abdominal fat by CT scan
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 28, 2019)
  • Gene Expression in Adipose Tissue [ Time Frame: 18 weeks ]
    Change in expression of genes involved in regulation of inflammation and insulin resistance
  • Inflammation [ Time Frame: 18 weeks ]
    Change in CRP level (mg/dl)
  • Dietary Macronutrient Intake [ Time Frame: 18 weeks ]
    Change in macronutrient composition of the diet
  • Glucose [ Time Frame: 18 weeks ]
    Change in fasting blood glucose (mg/dl)
  • Insulin [ Time Frame: 18 weeks ]
    Change in serum insulin (mg/dl)
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Tree Nut Consumption to Reduce Abdominal Adiposity
Official Title  ICMJE Tree Nut Consumption to Reduce Abdominal Adiposity and Risk for Metabolic Syndrome in Millennials
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
Randomized parallel two-arm study.
Masking: Double (Investigator, Outcomes Assessor)
Masking Description:
Investigator and research assistant are blinded to study intervention.
Primary Purpose: Prevention
Condition  ICMJE
  • Millenials
  • Risk for Metabolic Syndrome
Intervention  ICMJE Other: High Carbohydrate or Tree Nut Food Snacks
Snack consumption
Study Arms  ICMJE
  • Active Comparator: Carb Snacks
    Will follow study diet based on the Dietary Guidelines and consume study carbohydrate snacks between meals.
    Intervention: Other: High Carbohydrate or Tree Nut Food Snacks
  • Experimental: Tree Nut Snacks
    Will follow study diet based on the Dietary Guidelines and consume study tree nut snacks between meals.
    Intervention: Other: High Carbohydrate or Tree Nut Food Snacks
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: May 28, 2019) 		112
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE May 30, 2022
Estimated Primary Completion Date January 1, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Age 22-36 years
  • BMI 18.5 to 29.9
  • 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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 22 Years to 36 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Heidi Silver, PhD 6158759355 heidi.j.silver@vumc.org
Contact: Dianna Olson, RD 6159360365 dianna.olson@vumc.org
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03969264
Other Study ID Numbers  ICMJE VUMC71426
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Plan Description: No current plan to share IPD with other researchers.
Responsible Party Heidi J. Silver, Vanderbilt University Medical Center
Study Sponsor  ICMJE Vanderbilt University Medical Center
Collaborators  ICMJE International Tree Nut Council Research and Education Foundation
Investigators  ICMJE
Principal Investigator: Heidi Silver, PhD Vanderbilt University Medical Center
PRS Account Vanderbilt University Medical Center
Verification Date November 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

治疗医院

新药特效药

前沿医讯