Overweight (BMI > 25)NCT07497555
Anti-Inflammatory Effects of Pecan Nut Oil Supplementation in Adults With Overweight: A Randomized Controlled Parallel-Group Clinical Trial
A study testing Pecan nut oil supplementation in people with Overweight (BMI > 25), run by Universidad Autonoma de Nuevo Leon at 1 site in Mexico.
Trial summary
The goal of this clinical trial is to evaluate whether daily supplementation with cold-pressed pecan nut oil can reduce inflammation in adults with overweight. The main questions it aims to answer are: Does pecan nut oil supplementation reduce inflammatory biomarkers, including C-reactive protein (CRP), interleukin-6… Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Overweight (BMI > 25)
- What is being tested?
- Pecan nut oil supplementation
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteMexico
- Study dates
- 15 Oct 2025to 30 Jul 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Adults aged 18 to 65 years
- Body mass index (BMI) ≥25 and <30 kg/m² (overweight)
- Willingness to participate and provide written informed consent
- Ability to comply with study procedures and attend scheduled visits
- Stable dietary habits and physical activity levels during the study period
Who cannot join
- Diagnosis of chronic diseases such as diabetes mellitus, cardiovascular disease, liver disease, renal disease, or autoimmune disorders
- Use of anti-inflammatory medications, lipid-lowering drugs, or dietary supplements within the last 3 months
- Smoking or excessive alcohol consumption
- Pregnancy or lactation
- Known allergy or intolerance to nuts or nut-derived products
- Participation in another clinical trial within the last 3 months
- Any condition that, in the investigator's opinion, may interfere with study participation or outcomes
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Mexico1 site, 1 recruiting
- Recruiting
Facultad de Salud Pública y Nutrición, Universidad Autónoma de Nuevo León
Monterrey, Nuevo León, 64460
Heriberto Castro García, PhD, +52 8113404890 ext. 3081, heriberto.castrogr@uanl.edu.mx
Aurora Stephanie Hilario-Azuara, QFBT, +528146308248, auhilario_al@ciatej.edu.mx
About this study
Official title: Anti-Inflammatory Effects of Pecan Nut Oil Supplementation in Adults With Overweight: A Non-Randomized Controlled Parallel-Group Clinical Trial
The goal of this clinical trial is to evaluate whether daily supplementation with cold-pressed pecan nut oil can reduce inflammation in adults with overweight. The main questions it aims to answer are:
Does pecan nut oil supplementation reduce inflammatory biomarkers, including C-reactive protein (CRP), interleukin-6 (IL-6), and tumor necrosis factor-alpha (TNF-α)? Does pecan nut oil supplementation improve biochemical parameters such as fasting blood glucose and lipid profile? Researchers will compare an experimental group receiving pecan nut oil to a control group with no intervention to determine its effect on inflammation and metabolic parameters.
Read more
Participants will:
Consume 30 g/day of cold-pressed pecan nut oil under fasting conditions for 8 weeks (experimental group) Maintain their usual diet and physical activity throughout the study Attend two evaluation visits (baseline and Day 60) for blood sample collection and anthropometric measurements Provide dietary information using a 24-hour dietary recall
- Conditions
- Overweight (BMI > 25)
- Being tested
- Pecan nut oil supplementation
- Keywords
- pecan nut oil, overweight, controlled trial, nutraceuticals, chronic low-grade inflammation
- Medical subject headings
- Overweight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pecan nut oil supplementationDietary supplement
Pecan nut oil will be administered as a dietary supplement by oral intake in a standardized daily dose of 30 mL/day for 60 days. The oil will be obtained through cold pressing, ensuring minimal processing and preservation of its bioactive compounds, particularly unsaturated fatty acids and antioxidants constituents.
This intervention is distinguished from conventional dietary interventions by the use of a regionally sourced pecan nut oil with defined physicochemical and oxidative stability characteristics, allowing for controlled evaluation of its nutraceutical potencial. Unlike general dietary modifications, this study focuses on a single, standardized bioactive source to specifically assess its role in modulating inflammatory biomarkers and metabolic parameters in adults with overweight.
| Study group | Role | What they receive |
|---|---|---|
| Pecan nut oil supplementation | Experimental | Participants in the experimental group will receive daily supplementation with pecan nut oil. The oil will be administered orally in standardized dose of 30 mL/day for a period of 60 days. The intervention aims to evaluate the anti-inflammatory effects and impact on metabolic and biochemical parameters in adults with overweight. Receives: Dietary Supplement: Pecan nut oil supplementation |
| Control group | No intervention | Participants in the control group will not receive any supplementation and will be intructed to maintain their usual diet and lifestyle throughout the study period. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in interleukin-6 (IL-6) levels
The primary outcome will be the change in serum interleukin-6 (IL-6) levels, measured at baseline and after the intervention period, to assess the anti-inflammatory effect of pecan nut oil suplemmentation in adults with overweight.
Measured: Baseline and after 60 days of intervention
Change in tumor necrosis factor-alpha (TNF-α) levels
Changes in serum tumor necrosis factor-alpha (TNF-α) levels will be evaluated at baseline and after the intervention period as a key inflammatory marker.
Measured: Baseline and after 60 days of intervention.
Change in C-reactive protein (CRP) levels
The primary outcome will be the change in serum C-reactive protein (CRP) levels, measured at baseline and after 60 days of intervention, to evaluate the anti-inflammatory effect of pecan nut oil supplementation in adults with overweight.
Measured: Baseline and after 60 days after the start of intervention
Secondary outcomes (12)
Body weight (kg)
Body weight will be measured at baseline and after 60 days of intervention to assess changes associated with pecan nut oil supplementation.
Measured: Baseline and after 60 days of intervention
Body mass index (BMI)
Body mass index will be measured at baseline and after 60 days of intervention to assess changes associated with pecan nut oil supplementation.
Measured: Baseline and after 60 days of intervention
Body fat (%)
Body fat will be measured at baseline and after 60 days of intervention to assess changes associated with pecan nut oil supplementation.
Measured: Baseline and after 60 days of intervention
Waist circumference (cm)
Body weight will be measured at baseline and after 60 days of intervention to assess changes associated with pecan nut oil supplementation.
Measured: Baseline and after 60 days of intervention
Hip circumference (cm)
Hip circumference will be measured at baseline and after 60 days of intervention to assess changes associated with pecan nut oil supplementation.
Measured: Baseline and after 60 days of intervention
Change in fasting blood glucose
Difference in fasting blood glucose concentration between baseline (Day 0) and end of intervention (Day 60), measured in mg/dL.
Measured: Baseline and Day 60
Change in triglycerides (TG)
Difference in serum triglyceride levels between baseline (Day 0) and Day 60, measured in mg/dL.
Measured: Baseline and Day 60
Change in total cholesterol (TC)
Difference in total cholesterol levels between baseline (Day 0) and Day 60, measured in mg/dL.
Measured: Baseline and Day 60
Change in high-density lipoprotein cholesterol (HDL-c)
Difference in HDL cholesterol levels between baseline (Day 0) and Day 60, measured in mg/dL.
Measured: Baseline and Day 60
Change in low-density lipoprotein cholesterol (LDL-c)
Difference in LDL cholesterol levels between baseline (Day 0) and Day 60, measured in mg/dL.
Measured: Baseline and Day 60
Change in daily energy intake
Difference in daily energy intake between baseline (Day 0) and Day 60, estimated using 24-hour dietary recall, expressed in kcal/day.
Measured: Baseline and Day 60
Change in dietary intake assessed by 24-hour recall
Changes in dietary intake patterns assessed using a 24-hour dietary recall at baseline (Day 0) and Day 60.
Measured: Baseline and Day 60
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2026
- Study start15 Oct 2025
- Primary completion30 Jul 2026 (estimated)
- Study completion30 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Overweight (BMI > 25)Studies 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
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidad Autonoma de Nuevo Leon
- Sponsor type
- University, hospital or other
- Collaborators
- Hospital Universitario Dr. Jose E. Gonzalez, Centro de Investigación y Asistencia en Tecnología y Diseño del Estado de Jalisco
- Responsible party
- Principal investigator, Heriberto Castro Garcia, Universidad Autonoma de Nuevo Leon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07497555
- Sponsor's protocol ID
- 25-FaSPyN-SA-02
- Status last verified
- Feb 2026
- First submitted
- 23 Mar 2026
- Last updated
- 27 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Anti-Inflammatory Effects of Pecan Nut Oil Supplementation in Adults With Overweight: A Non-Randomized Controlled Parallel-Group Clinical Trial
- ClinicalTrials.gov ID
- NCT07497555
- Acronym / sponsor ID
- 25-FaSPyN-SA-02
- Conditions
- Overweight (BMI > 25)
- Keywords
- pecan nut oil, overweight, controlled trial, nutraceuticals, chronic low-grade inflammation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Universidad Autonoma de Nuevo LeonUniversity, hospital or other
- Collaborators
- Hospital Universitario Dr. Jose E. Gonzalez, Centro de Investigación y Asistencia en Tecnología y Diseño del Estado de Jalisco
- Study start
- 15 Oct 2025 (actual)
- Primary completion
- 30 Jul 2026 (estimated)
- Study completion
- 30 Jul 2026 (estimated)
- First posted
- 27 Mar 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.
The goal of this clinical trial is to evaluate whether daily supplementation with cold-pressed pecan nut oil can reduce inflammation in adults with overweight. The main questions it aims to answer are:
Does pecan nut oil supplementation reduce inflammatory biomarkers, including C-reactive protein (CRP), interleukin-6 (IL-6), and tumor necrosis factor-alpha (TNF-α)? Does pecan nut oil supplementation improve biochemical parameters such as fasting blood glucose and lipid profile? Researchers will compare an experimental group receiving pecan nut oil to a control group with no intervention to determine its effect on inflammation and metabolic parameters.
Participants will:
Consume 30 g/day of cold-pressed pecan nut oil under fasting conditions for 8 weeks (experimental group) Maintain their usual diet and physical activity throughout the study Attend two evaluation visits (baseline and Day 60) for blood sample collection and anthropometric measurements Provide dietary information using a 24-hour dietary recall
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pecan nut oil supplementation | Experimental | Dietary Supplement: Pecan nut oil supplementationParticipants in the experimental group will receive daily supplementation with pecan nut oil. The oil will be administered orally in standardized dose of 30 mL/day for a period of 60 days. The intervention aims to evaluate the anti-inflammatory effects and impact on metabolic and biochemical parameters in adults with overweight. |
| Control group | No intervention | –Participants in the control group will not receive any supplementation and will be intructed to maintain their usual diet and lifestyle throughout the study period. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Adults aged 18 to 65 years
- Body mass index (BMI) ≥25 and <30 kg/m² (overweight)
- Willingness to participate and provide written informed consent
- Ability to comply with study procedures and attend scheduled visits
- Stable dietary habits and physical activity levels during the study period
Key exclusion criteria (7 listed)
- Diagnosis of chronic diseases such as diabetes mellitus, cardiovascular disease, liver disease, renal disease, or autoimmune disorders
- Use of anti-inflammatory medications, lipid-lowering drugs, or dietary supplements within the last 3 months
- Smoking or excessive alcohol consumption
- Pregnancy or lactation
- Known allergy or intolerance to nuts or nut-derived products
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 nut oil supplementationPecan nut oil will be administered as a dietary supplement by oral intake in a standardized daily dose of 30 mL/day for 60 days. The oil will be obtained through cold pressing, ensuring minimal processing and preservation of its bioactive compounds, particularly unsaturated fatty acids and antioxidants constituents. This intervention is distinguished from conventional dietary interventions by the use of a regionally sourced pecan nut oil with defined physicochemical and oxidative stability characteristics, allowing for controlled evaluation of its nutraceutical potencial. Unlike general dietary modifications, this study focuses on a single, standardized bioactive source to specifically assess its role in modulating inflammatory biomarkers and metabolic parameters in adults with overweight. | Dietary supplement | Pecan nut oil supplementation |
Primary outcome
Change in interleukin-6 (IL-6) levels
Time frame: Baseline and after 60 days of intervention
The primary outcome will be the change in serum interleukin-6 (IL-6) levels, measured at baseline and after the intervention period, to assess the anti-inflammatory effect of pecan nut oil suplemmentation in adults with overweight.
Change in tumor necrosis factor-alpha (TNF-α) levels
Time frame: Baseline and after 60 days of intervention.
Changes in serum tumor necrosis factor-alpha (TNF-α) levels will be evaluated at baseline and after the intervention period as a key inflammatory marker.
Change in C-reactive protein (CRP) levels
Time frame: Baseline and after 60 days after the start of intervention
The primary outcome will be the change in serum C-reactive protein (CRP) levels, measured at baseline and after 60 days of intervention, to evaluate the anti-inflammatory effect of pecan nut oil supplementation in adults with overweight.
12 secondary outcomes
Body weight (kg)
Time frame: Baseline and after 60 days of intervention
Body mass index (BMI)
Time frame: Baseline and after 60 days of intervention
Body fat (%)
Time frame: Baseline and after 60 days of intervention
Waist circumference (cm)
Time frame: Baseline and after 60 days of intervention
Hip circumference (cm)
Time frame: Baseline and after 60 days of intervention
Change in fasting blood glucose
Time frame: Baseline and Day 60
Change in triglycerides (TG)
Time frame: Baseline and Day 60
Change in total cholesterol (TC)
Time frame: Baseline and Day 60
Change in high-density lipoprotein cholesterol (HDL-c)
Time frame: Baseline and Day 60
Change in low-density lipoprotein cholesterol (LDL-c)
Time frame: Baseline and Day 60
Change in daily energy intake
Time frame: Baseline and Day 60
Change in dietary intake assessed by 24-hour recall
Time frame: Baseline and Day 60
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2026.
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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.
Facultad de Salud Pública y Nutrición, Universidad Autónoma de Nuevo León
Monterrey, Mexico
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pecan nut oil supplementation in people with Overweight (BMI > 25), run by Universidad Autonoma de Nuevo Leon at 1 site in Mexico.
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 5 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: looking for participants now, as of the sponsor's last update on 27 Mar 2026. 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 Mexico. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in interleukin-6 (IL-6) levels (time frame: Baseline and after 60 days of intervention). The study lists 3 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 27 Mar 2026.