Obesity & OverweightNCT07732816
Effect of an Eight Week Dietary Intervention of Pecans on Cardiometabolic Parameters and Serum Cytokines in Individuals With Obesity or Overweight
A study testing Pecan Intervention in people with Obesity & Overweight, run by Viterbo University.
Trial summary
You are invited to participate in a research study being conducted by Karen Gibson, Maria Morgan-Bathke, Dana Swope, Grace Huebner, Rebecca Brannan, Samuel McCormick at Viterbo University. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity & Overweight
- What is being tested?
- Pecan Intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- No sites listed yet
- Study dates
- 17 Oct 2016to 17 Oct 2018
- 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 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- BMI of 25.0-40.0
Who cannot join
- BMI below 25.0 or over 40.0
- anyone who works a 3rd shift
- pregnant and breastfeeding women
- those with pre-existing chronic conditions
- those with a latex allergy
About this study
You are invited to participate in a research study being conducted by Karen Gibson, Maria Morgan-Bathke, Dana Swope, Grace Huebner, Rebecca Brannan, Samuel McCormick at Viterbo University. The purpose of this research is to determine the effectiveness of using nuts and avocados as a dietary intervention on improving fasting blood glucose, lipid profile, energy expenditure, and body composition on pre-diabetic individuals compared to a control group. We hope to learn if a dietary intervention of nuts or avocado can help improve blood sugar, lipid panel and/or body composition. You were selected as a possible participant in this study because you have been diagnosed with pre-diabetes. If you decide to participate, you will be asked to complete an initial two hour appointment, follow the protocol of one of the interventions (one avocado or 1 ½ ounce nuts) and control group with only dietary counseling provided) daily for an eight week period, weekly telephone and/or email nutrition counseling, and attend a final two hour appointment. The food for the intervention (avocados and nuts) will be provided by the researchers and will not need to be purchased by the participants. The initial and final two hour appointments will consist of the following measurements: An overnight fast, blood glucose, cytokine level, and lipid panel tests will be completed by a venous blood draw. Then Maltron scan (to measure body composition, which in non-invasive and uses electrodes on the skin), waist/hip measurements, height/weight, and VioCare food frequency questionnaire will be completed. Following these screening measurements, a COSMED test to determine resting energy expenditure (REE) will be measured.
It may take approximately 10 weeks from beginning to completion of this study.
- Conditions
- Obesity & Overweight
- Being tested
- Pecan Intervention
- Keywords
- obesity, monounsaturated fatty acids, pecans, cardiometabolic health, inflammation, dietary intake
- Medical subject headings
- Obesity, Overweight, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pecan InterventionOther
1.5 oz of pecans daily
| Study group | Role | What they receive |
|---|---|---|
| control | No intervention | control group |
| pecan group | Experimental | pecan intervention Receives: Other: Pecan Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
body composition
percentage body fat
Measured: 10 weeks
fasting blood glucose
fasting blood glucose in mg/dl
Measured: 10 weeks
weight
weight in kg
Measured: 10 weeks
height
height in meters
Measured: 10 weeks
total cholesterol
total cholesterol in mg/dl
Measured: 10 weeks
LDL cholesterol
LDL cholesterol in mg/dl
Measured: 10 weeks
HDL
HDL cholesterol in mg/dl
Measured: 10 weeks
TG
triglycerides in mg/dl
Measured: 10 weeks
Secondary outcomes (2)
inflammation
circulating inflammation via plasma TNF-alpha in pg/ml
Measured: 10 weeks
anti-inflammatory
circulating inflammation via plasma IL-10 in pg/ml
Measured: 10 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2026
- Study start17 Oct 2016
- Primary completion17 Oct 2018
- Study completion17 Oct 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obesity & OverweightStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Viterbo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Maria Morgan-Bathke, Viterbo University
- Investigators
- Maria Morgan-Bathke, PhD, Principal investigator, Viterbo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07732816
- Sponsor's protocol ID
- 1189
- Status last verified
- Jul 2026
- First submitted
- 15 Jul 2026
- Last updated
- 29 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of an Eight Week Dietary Intervention of Pecans on Cardiometabolic Parameters and Serum Cytokines in Individuals With Obesity or Overweight
- ClinicalTrials.gov ID
- NCT07732816
- Acronym / sponsor ID
- 1189
- Conditions
- Obesity & Overweight
- Keywords
- obesity, monounsaturated fatty acids, pecans, cardiometabolic health, inflammation, dietary intake
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Viterbo UniversityUniversity, hospital or other
- Study start
- 17 Oct 2016 (actual)
- Primary completion
- 17 Oct 2018 (actual)
- Study completion
- 17 Oct 2018 (actual)
- First posted
- 29 Jul 2026 (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.
You are invited to participate in a research study being conducted by Karen Gibson, Maria Morgan-Bathke, Dana Swope, Grace Huebner, Rebecca Brannan, Samuel McCormick at Viterbo University. The purpose of this research is to determine the effectiveness of using nuts and avocados as a dietary intervention on improving fasting blood glucose, lipid profile, energy expenditure, and body composition on pre-diabetic individuals compared to a control group. We hope to learn if a dietary intervention of nuts or avocado can help improve blood sugar, lipid panel and/or body composition. You were selected as a possible participant in this study because you have been diagnosed with pre-diabetes. If you decide to participate, you will be asked to complete an initial two hour appointment, follow the protocol of one of the interventions (one avocado or 1 ½ ounce nuts) and control group with only dietary counseling provided) daily for an eight week period, weekly telephone and/or email nutrition counseling, and attend a final two hour appointment. The food for the intervention (avocados and nuts) will be provided by the researchers and will not need to be purchased by the participants. The initial and final two hour appointments will consist of the following measurements: An overnight fast, blood glucose, cytokine level, and lipid panel tests will be completed by a venous blood draw. Then Maltron scan (to measure body composition, which in non-invasive and uses electrodes on the skin), waist/hip measurements, height/weight, and VioCare food frequency questionnaire will be completed. Following these screening measurements, a COSMED test to determine resting energy expenditure (REE) will be measured.
It may take approximately 10 weeks from beginning to completion of this study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| control | No intervention | –control group |
| pecan group | Experimental | Other: Pecan Interventionpecan intervention |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- BMI of 25.0-40.0
Key exclusion criteria (5 listed)
- BMI below 25.0 or over 40.0
- anyone who works a 3rd shift
- pregnant and breastfeeding women
- those with pre-existing chronic conditions
- those with a latex allergy
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 |
|---|---|---|
| Pecan Intervention1.5 oz of pecans daily | Other | pecan group |
Primary outcome
body composition
Time frame: 10 weeks
percentage body fat
fasting blood glucose
Time frame: 10 weeks
fasting blood glucose in mg/dl
weight
Time frame: 10 weeks
weight in kg
height
Time frame: 10 weeks
height in meters
total cholesterol
Time frame: 10 weeks
total cholesterol in mg/dl
LDL cholesterol
Time frame: 10 weeks
LDL cholesterol in mg/dl
HDL
Time frame: 10 weeks
HDL cholesterol in mg/dl
TG
Time frame: 10 weeks
triglycerides in mg/dl
2 secondary outcomes
inflammation
Time frame: 10 weeks
anti-inflammatory
Time frame: 10 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 29 Jul 2026.
- Individual participant dataSharing planned: No
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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.
Maria Morgan-Bathke, PhD principal investigator
Viterbo University
Questions about this trial
What is this clinical trial studying?
A study testing Pecan Intervention in people with Obesity & Overweight, run by Viterbo University.
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 1 inclusion and 5 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 29 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
body composition (time frame: 10 weeks). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 29 Jul 2026.