Research on Effects of Acute Consumption of Nuts in Obese Diabetic Women
REACT-NUT
Influence of Acute Nut Intake on the Effects of High Saturated Fat Meals in Obese Diabetic Women
1 other identifier
interventional
15
1 country
1
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%.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable type-2-diabetes
Started Jan 2025
Shorter than P25 for not_applicable type-2-diabetes
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 12, 2024
CompletedFirst Posted
Study publicly available on registry
November 29, 2024
CompletedStudy Start
First participant enrolled
January 15, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 15, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
July 15, 2025
CompletedApril 6, 2025
April 1, 2025
3 months
November 12, 2024
April 4, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Oxidative stress assessment
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.
6 weeks
Metabolomic profile assessment
Serum concentrations of malondialdehyde (MDA) will be measured by high-performance liquid chromatography (HPLC) based on the reaction with thiobarbituric acid in µmol/L.
6 weeks
Study Arms (2)
Nuts in the first meeting
OTHERIn 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.
Nuts in the second meeting
PLACEBO COMPARATORIn 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.
Interventions
Eligibility Criteria
You may qualify if:
- Women over 18 years of age
- Diagnosis of obesity (body mass index \[BMI \>30 kg/m²\])
- Diagnosis of non-insulin-dependent type II diabetes
You may not qualify if:
- 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 the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
São Paulo State University (UNESP), Medical School, Botucatu
Botucatu, São Paulo, 18.618-970, Brazil
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Marcos M Ferreira, PhD
FMB/Unesp
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
November 12, 2024
First Posted
November 29, 2024
Study Start
January 15, 2025
Primary Completion
April 15, 2025
Study Completion
July 15, 2025
Last Updated
April 6, 2025
Record last verified: 2025-04
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
- Time Frame
- At the end of the study, data will be permanently placed in the institutional repository and made available. Blood samples will be stored in the biorepository for up to five years.
- Access Criteria
- The data will be available in the institutional repository to anyone upon request.
Collected data will be stored in Excel format on specific folders and backed up on external (USB drive) and cloud storage under the researcher's care. Metadata will include file title, researcher's ORCID, file summary, collection date and project number (if available). The project was approved by the Botucatu School of Medicine's Ethics Committee, and informed consent will be obtained from participants or guardians. Data will be analyzed in SigmaPlot 12.0, and files will be accessible via standard software. Tabulated data will be preserved indefinitely, with access limited to the research team, and clinical trial data will be anonymized. Tissue samples will be stored at -80°C for up to five years. Partial data may be presented at scientific events, and final data will be published as a scientific article. Raw data will be indefinitely retained by the researcher, available upon request, and shared in the institutional repository under anonymization.