Clinical trial

Research on Effects of Acute Consumption of Nuts in Obese Diabetic Women

Recruiting now · Not applicable · 1 countries · Registry ID NCT06710340

Recruiting nowNot applicableInterventional

What this study is about

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%.

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age18 Years to Not listed

SexFemale

Healthy volunteersNot accepted

ConditionType 2 Diabetes, Obesity

Full registry 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

Treatments and study arms

Nuts in the first meeting

Dietary Supplement

30g of walnuts

Nuts in the second meeting

Other

30g of walnuts

Primary outcomes

Oxidative stress assessment6 weeks

The cytokines TNF-alpha, IL-6, IL-1β, IL-1ra, IL-8, and IL-10 will be measured by ELISA following the manufacturer's instructions for the kits in pg/mL.

Metabolomic profile assessment6 weeks

Serum concentrations of malondialdehyde (MDA) will be measured by high-performance liquid chromatography (HPLC) based on the reaction with thiobarbituric acid in µmol/L.

Study locations

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São Paulo State University (UNESP), Medical School, Botucatu🇧🇷 Botucatu, São Paulo, Brazil

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Raquel S Ballarin, M.D.Contact

Email · Call 14997864806

Nayane M Vieira, MasterPrincipal Investigator

Taline Lazzarin, M.D.Principal Investigator