Ignite Creation Date:
2025-12-24 @ 2:47 PM
Ignite Modification Date:
2025-12-26 @ 1:48 PM
Study NCT ID:
NCT06735859
Status:
RECRUITING
Last Update Posted:
2025-12-16
First Post:
2024-12-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Eating Window and Sleep Disorders on Glycemic Control, Cardiovascular Risk, and Weight Loss
Sponsor:
Federal University of São Paulo
Organization:
Study Overview
Official Title:
Impact of Eating Window and Sleep Disorders on Glycemic Control, Cardiovascular Risk, and Weight Loss in Chronic Diseases
Status:
RECRUITING
Status Verified Date:
2025-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This project aims to offer a quantitative and qualitative nutritional approach, along with educational nutritional guidelines for participants with Non-Communicable Chronic Diseases. The main goals are: 1- Regularization of eating habits and windows; 2- Modulation of biochemical, anthropometric, and cardiovascular parameters; 3- Increase in knowledge about healthy eating. In this way, participants will undergo a complete nutritional assessment, comprising anthropometry, biochemistry, clinical, and dietary evaluations.
Detailed Description:
The study will be conducted at the Endocrinology and Hypertension Clinic of the São José do Rio Preto Medical School between 2026 and 2027, with the objective of collecting comprehensive data for an in-depth analysis of the participants. Eligible individuals will be randomly assigned to two intervention groups. Participants in the first group will follow a daytime eating window (7:00 a.m. to 7:00 p.m.), while those in the second group will follow a nighttime eating window (12:00 p.m. to 12:00 a.m.). Nutritional consultations will be conducted individually at five assessment points: Month 0 (baseline), Month 6 (end of first intervention phase), Month 9 (end of washout), Month 15 (end of second intervention phase), and Month 18 (follow-up). Each consultation will last approximately one hour per participant, and all participants will receive appointment reminders via phone or WhatsApp.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: