NCT06710340 Research on Effects of Acute Consumption of Nuts in Obese Diabetic Women
| NCT ID | NCT06710340 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Raquel Ballarin |
| Condition | Type 2 Diabetes |
| Study Type | INTERVENTIONAL |
| Enrollment | 15 participants |
| Start Date | 2025-01-15 |
| Primary Completion | 2025-04-15 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 15 participants in total. It began in 2025-01-15 with a primary completion date of 2025-04-15.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Obesity is a multifactorial disease in which excess body fat accumulation increases the risk of other chronic diseases such as type 2 diabetes. The primary cause of obesity is the energy imbalance between calories consumed and expended. A balanced diet is essential for weight control and maintaining a healthy body weight. In this context, the intake of a high saturated fat meal (HSFM) plays a detrimental role, contributing to the development of obesity, type 2 diabetes, cancer, cardiovascular diseases, and exacerbating chronic inflammation. Additionally, it may induce metabolic endotoxemia and modulate profiles of circulating microRNAs. Therefore, due to the harmful health impacts of HSFM, studies on metabolomics and circulating microRNA levels could enhance understanding of the mechanisms of walnuts (Juglans regia) in the prevention and treatment of diseases. The aim of this study is to evaluate whether acute walnut supplementation attenuates the inflammatory response, oxidative stress, glycemic response, and regulates the metabolomic and circulating microRNA responses induced by HSFM in women with obesity and type 2 diabetes. The study will be randomized and crossover, including obese, non-insulin-dependent diabetic women aged over 18, without other comorbidities. In the first phase, participants will arrive at the clinic after a 10-hour fast and will be offered HSFM with or without 30g of walnuts. In the second phase, participants who did not receive walnuts will now receive them along with the HSFM and vice versa. Blood samples will be collected, and serum insulin, glucose, serum biomarkers of inflammation and oxidative stress will be evaluated. TNF-alpha, IL-6, IL-1β, IL-1ra, IL-8, and IL-10 will be measured by ELISA, and MDA by HPLC. Additionally, metabolomic and microRNA analyses will be conducted. Data analysis will be performed using JAMOVI v 2.3.21, with a significance level of 5%.
Eligibility Criteria
Inclusion Criteria: * Women over 18 years of age * Diagnosis of obesity (body mass index \[BMI \>30 kg/m²\]) * Diagnosis of non-insulin-dependent type II diabetes Exclusion Criteria: * Use of dietary supplements or corticosteroid use in the last 3 months * Diagnosis of insulin dependent diabetes * Diagnosis of cancer * Diagnosis of heart failure * Diagnosis of kidney diseases * Diagnosis of liver diseases * Diagnosis of lung diseases * Diagnosis ofneurological diseases * Diagnosis of allergy to any component of the high saturated fat meal or walnuts
Contact & Investigator
Marcos M Ferreira, PhD
PRINCIPAL INVESTIGATOR
FMB/Unesp
Frequently Asked Questions
Who can join the NCT06710340 clinical trial?
This trial is open to female participants only, aged 18 Years or older, studying Type 2 Diabetes. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06710340 currently recruiting?
Yes, NCT06710340 is actively recruiting participants. Contact the research team at raquel.ballarin@unesp.br for enrollment information.
Where is the NCT06710340 trial being conducted?
This trial is being conducted at Botucatu, Brazil.
Who is sponsoring the NCT06710340 clinical trial?
NCT06710340 is sponsored by Raquel Ballarin. The principal investigator is Marcos M Ferreira, PhD at FMB/Unesp. The trial plans to enroll 15 participants.
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