MillenialsNCT03969264
Tree Nut Consumption to Reduce Abdominal Adiposity
A study testing High Carbohydrate or Tree Nut Food Snacks in people with Millenials and Risk for Metabolic Syndrome, run by Vanderbilt University Medical Center at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 22 to 36 yearsHealthy volunteers can take part
- Conditions the study is for
- Millenials, Risk for Metabolic Syndrome
- What is being tested?
- High Carbohydrate or Tree Nut Food Snacks
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 84 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Jul 2019to 30 Jun 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 22 to 36 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Vanderbilt University Medical Center
Nashville, Tennessee, 37232
About this study
Official title: Tree Nut Consumption to Reduce Abdominal Adiposity and Risk for Metabolic Syndrome in Millennials
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.
Read the 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.
- Conditions
- Millenials, Risk for Metabolic Syndrome
- Being tested
- High Carbohydrate or Tree Nut Food Snacks
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High Carbohydrate or Tree Nut Food SnacksOther
Snack consumption
| Study group | Role | What they receive |
|---|---|---|
| Carb Snacks | Active comparator | Will follow study diet based on the Dietary Guidelines and consume study carbohydrate snacks between meals. Receives: Other: High Carbohydrate or Tree Nut Food Snacks |
| Tree Nut Snacks | Experimental | Will follow study diet based on the Dietary Guidelines and consume study tree nut snacks between meals. Receives: Other: High Carbohydrate or Tree Nut Food Snacks |
What is being measured
The primary outcome is the main question the study is designed to answer.
Waist circumference
Change in waist circumference (in centimeters)
Measured: 18 weeks
Visceral Fat
Change in quantity of intra-abdominal fat by CT scan
Measured: 18 weeks
Secondary outcomes (5)
Gene Expression in Adipose Tissue
Change in expression of genes involved in regulation of inflammation and insulin resistance
Measured: 18 weeks
Inflammation
Change in CRP level (mg/dl)
Measured: 18 weeks
Dietary Macronutrient Intake
Change in macronutrient composition of the diet
Measured: 18 weeks
Glucose
Change in fasting blood glucose (mg/dl)
Measured: 18 weeks
Insulin
Change in serum insulin (mg/dl)
Measured: 18 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2019
- Study start15 Jul 2019
- Primary completion30 Jun 2023
- Study completion30 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for MillenialsStudies of the same condition, open and under way.
- More trials run by Vanderbilt University Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized parallel two-arm study.
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 84 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vanderbilt University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- International Tree Nut Council Research and Education Foundation
- Responsible party
- Principal investigator, Heidi J. Silver, Vanderbilt University Medical Center
- Investigators
- Heidi Silver, PhD, Principal investigator, Vanderbilt University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03969264
- Sponsor's protocol ID
- VUMC71426
- Status last verified
- Dec 2023
- First submitted
- 23 May 2019
- Last updated
- 5 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No current plan to share IPD with other researchers.
Publications
Widmer A, Lillegard K, Wood K, Robles M, Fan R, Ye F, Koethe JR, Silver HJ. Consumption of tree nuts as snacks stimulates changes in plasma fatty acid profiles and adipose tissue gene expression in young adults at risk for metabolic syndrome. Clin Nutr. 2025 May;48:25-34. doi: 10.1016/j.clnu.2025.03.002. Epub 2025 Mar 8.
PubMed 40117963
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tree Nut Consumption to Reduce Abdominal Adiposity and Risk for Metabolic Syndrome in Millennials
- ClinicalTrials.gov ID
- NCT03969264
- Acronym / sponsor ID
- VUMC71426
- Conditions
- Millenials, Risk for Metabolic Syndrome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 84 participants (actual)
- Lead sponsor
- Vanderbilt University Medical CenterUniversity, hospital or other
- Collaborators
- International Tree Nut Council Research and Education Foundation
- Study start
- 15 Jul 2019 (actual)
- Primary completion
- 30 Jun 2023 (actual)
- Study completion
- 30 Jun 2023 (actual)
- First posted
- 31 May 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized parallel two-arm study.
| Arm | Type | Receives |
|---|---|---|
| Carb Snacks | Active comparator | Other: High Carbohydrate or Tree Nut Food SnacksWill follow study diet based on the Dietary Guidelines and consume study carbohydrate snacks between meals. |
| Tree Nut Snacks | Experimental | Other: High Carbohydrate or Tree Nut Food SnacksWill follow study diet based on the Dietary Guidelines and consume study tree nut snacks between meals. |
Who may qualify
- Ages
- 22 to 36 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (7 listed)
- Tree nut allergy
- Diagnosed chronic disease
- Medication for dyslipidemia or hypertension
- Smoke
- Weight loss medication
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| High Carbohydrate or Tree Nut Food SnacksSnack consumption | Other | Carb Snacks, Tree Nut Snacks |
Primary outcome
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
5 secondary outcomes
Gene Expression in Adipose Tissue
Time frame: 18 weeks
Inflammation
Time frame: 18 weeks
Dietary Macronutrient Intake
Time frame: 18 weeks
Glucose
Time frame: 18 weeks
Insulin
Time frame: 18 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Dec 2023.
- Derived from this study: PubMed 40117963Widmer A, Lillegard K, Wood K, Robles M, Fan R, Ye F, Koethe JR, Silver HJ. Consumption of tree nuts as snacks stimulates changes in plasma fatty acid profiles and adipose tissue gene expression in young adults at risk for metabolic syndrome. Clin Nutr. 2025 May;48:25-34. doi: 10.1016/j.clnu.2025.03.002. Epub 2025 Mar 8.
- Individual participant dataSharing planned: No. No current plan to share IPD with other researchers.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Heidi Silver, PhD principal investigator
Vanderbilt University Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High Carbohydrate or Tree Nut Food Snacks in people with Millenials and Risk for Metabolic Syndrome, run by Vanderbilt University Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Waist circumference (time frame: 18 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03969264, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Dec 2023.