NCT07324044Not yet recruiting
Chrono-ALIGN: A Chronotype-Based Chrono-Nutrition Intervention in Post-Bariatric Patients
Chrono-ALIGN Trial: The Impact of Chronotype-Based Chrono-Nutrition on Metabolic Health, Gut Microbiota, Appetite, and Circadian Alignment in Post-Bariatric Surgery Patients: A Randomized Controlled Trial
Source: ClinicalTrials.gov · Last updated 7 Jan 2026
Brief summary (registry, in English)
This randomized controlled trial will evaluate the impact of chrono-nutrition, a dietary approach that aligns meal timing with the body's circadian rhythms, on weight change, metabolic outcomes, appetite, and gut microbiota in post-bariatric surgery patients. A total of 246 adults who underwent sleeve gastrectomy at least six months earlier will be enrolled at King Saud Medical City. Participants will be randomized to receive either standard post-bariatric nutritional care or personalized chrono-nutrition based on individual chronotype. Outcomes include weight change, metabolic biomarkers, dietary behaviors, sleep patterns, and gut microbiota composition. The study aims to determine whether integrating chrono-nutrition into post-bariatric follow-up can enhance metabolic health and improve long-term health.
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 246 (estimated)
- First submitted
- 23 Dec 2025
- Start date
- 1 Jan 2026
- Primary completion date
- 1 Dec 2027
- Lead sponsor
- King Saud University
- Diseases
- Obesity
- NCT number
- NCT07324044
What you commit to
- Study type: Interventional
- Planned participants: 246
- From 1 Jan 2026 to the primary completion date, 1 Dec 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- • Pregnancy or planned pregnancy during the study period, and post menopaused females
- Current diagnosis of severe psychiatric illness that may interfere with adherence (e.g., untreated major depression, psychosis, severe eating disorders).
- Active malignancy or serious chronic disease unrelated to obesity that may confound outcomes (e.g., advanced renal failure, uncontrolled liver disease).
- Use of medications known to significantly alter circadian rhythm or metabolism (e.g., corticosteroids, melatonin therapy) within the last 3 months.
- Inability to comply with study requirements (dietary interventions, sample collection, or follow-up visits).Participants who have previously undergone revision bariatric surgery.
- Individuals following intermittent fasting regimens prior to the study.
Who the study is looking for
- Adults aged 18-50 years who underwent Sleeve Gastrectomy (SG) 6 Months prior to enrollment.
- Have achieved ≥50% of excess weight loss post-surgery (to ensure initial success).
- Current BMI between 25-40 kg/m².
- No major postoperative complications and cleared for a regular diet by their healthcare provider.
- Participants must be able to align their eating schedule within a daytime window (morning to evening), ensuring that the first meal is consumed in the early part of the day and the last meal is completed before late evening, in accordance with chrono-nutrition guidelines.
Age in the registry: 18 years to 50 years · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| King Saud Medical City Coordinator of this site? Confirm its status | Riyadh | Saudi Arabia | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.