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

Condition(s) studied

Investigational drug(s) / intervention(s)

Nuts in the first meeting: 30g of walnuts

Nuts in the second meeting: 30g of walnuts

Study 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

Primary outcome measure(s)

• Oxidative stress assessment — 6 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 assessment — 6 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.

Trial sites (1)

Other trials for the same condition