Actively Recruiting

Phase Not Applicable
Age: 18Years +
FEMALE
NCT06710340

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

Led by Raquel Ballarin · Updated on 2025-04-06

15

Participants Needed

1

Research Sites

25 weeks

Total Duration

On this page

Sponsors

R

Raquel Ballarin

Lead Sponsor

F

Faculdade de Medicina de Botucatu, UNESP, Botucatu, Brasil

Collaborating Sponsor

AI-Summary

What this Trial 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%.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Women over 18 years of age
  • Diagnosis of obesity (body mass index [BMI >30 kg/m²])
  • Diagnosis of non-insulin-dependent type II diabetes
Not Eligible

You will not qualify if you...

  • 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 of neurological diseases
  • Diagnosis of allergy to any component of the high saturated fat meal or walnuts

AI-Screening

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Trial Site Locations

Total: 1 location

1

São Paulo State University (UNESP), Medical School, Botucatu

Botucatu, São Paulo, Brazil, 18.618-970

Actively Recruiting

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Research Team

R

Raquel S Ballarin, M.D.

CONTACT

N

Nayane M Vieira, Master

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

CROSSOVER

Primary Purpose

PREVENTION

Number of Arms

2

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