Influence of Acute Nut Intake on the Effects of High Saturated Fat Meals in Obese Diabetic Women

Status: Recruiting
Location: See location...
Intervention Type: Other, Dietary supplement
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: Female
Minimum Age: 18
Healthy Volunteers: f
View:

• Women over 18 years of age

• Diagnosis of obesity (body mass index \[BMI \>30 kg/m²\])

• Diagnosis of non-insulin-dependent type II diabetes

Locations
Other Locations
Brazil
São Paulo State University (UNESP), Medical School, Botucatu
RECRUITING
Botucatu
Contact Information
Primary
Raquel S Ballarin, M.D.
raquel.ballarin@unesp.br
5514997864806
Backup
Nayane M Vieira, Master
n.vieira@unesp.br
5514996536445
Time Frame
Start Date: 2025-01-15
Estimated Completion Date: 2025-07-15
Participants
Target number of participants: 15
Treatments
Other: Nuts in the first meeting
In the first session, after a 10-hour fasting, a high saturated fat meal with 30g of nuts will be offered.~In the second session, after a 10-hour fasting, a high saturated fat meal without 30g of nuts will be offered.
Placebo_comparator: Nuts in the second meeting
In the first session, after a 10-hour fasting, a high saturated fat meal without 30g of nuts will be offered.~In the second session, after a 10-hour fasting, a high saturated fat meal with 30g of nuts will be offered.
Related Therapeutic Areas
Sponsors
Collaborators: Faculdade de Medicina de Botucatu, UNESP, Botucatu, Brasil
Leads: Raquel Ballarin

This content was sourced from clinicaltrials.gov