Clinical trial

Chrono-ALIGN: A Chronotype-Based Chrono-Nutrition Intervention in Post-Bariatric Patients

Opening soon · Not applicable · 1 countries · Registry ID NCT07324044

Opening soonNot applicableInterventional

What this study is about

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.

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age18 Years to 50 Years
SexAll
Healthy volunteersAccepted
ConditionObesity (Disorder), Morbid Obesity, Bariatric Sleeve Gastrectomy, Meal Time, Chronotype, Circadian Rhythm

Full registry criteria

Inclusion Criteria: * 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. Exclusion Criteria: * • 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.

Treatments and study arms

Standard Post-Bariatric Care (Control)

Behavioral

Participants receive routine post-bariatric nutritional care with no prescribed meal-timing window. Dietitians provide standard guidance on protein adequacy (\~60-80 g/day unless otherwise indicated), hydration, and routine micronutrient supplementation per clinic practice. Follow-ups occur at 3, 6, and 12 months; outcomes include body weight, metabolic markers, appetite-related hormones, questionnaires, wearables, and stool samples. This arm controls for the effects of usual care and non-timing dietary counseling.

Early Time-Restricted Eating (eTRE)

Behavioral

Participants consume all caloric intake within a fixed daytime 10-hour window (08:00-18:00) on ≥6 days/week. Water/unsweetened tea/black coffee are allowed outside the window. Diet composition follows bariatric guidelines (protein \~60-80 g/day, hydration, routine micronutrients). Dietitians provide structured meal-timing plans and problem-solving support; timing logs and wearables document adherence. Assessments at 3, 6, and 12 months mirror the control arm.

Chronotype-Based Chrono-Nutrition (CB-CN)

Behavioral

Meal timing is personalized to chronotype (morning/intermediate/evening) determined with the Munich Chronotype Questionnaire (MCTQ). Plans target an earlier first meal and completion of the last meal ≥3-4 h before habitual bedtime, with an eating window of \~10 h/day on ≥6 days/week, adjusted to chronotype using stepwise phase-advance strategies where needed. Diet composition follows bariatric guidelines (protein, hydration, micronutrients). Timing logs and wearables track adherence; visits at 3, 6, and 12 months.

Primary outcomes

Change in weight maintenance and insulin sensitivityBaseline, 3 months, 6 months, and 12 months

Evaluate the effect of personalized chrono-nutrition interventions (early time-restricted eating and chronotype-based nutrition) on weight loss maintenance and insulin sensitivity in post-bariatric patients.

Study locations

1 locations were listed when this page was built. The first 40 are shown.

King Saud Medical City🌐 Riyadh, Saudi Arabia
Amani Alfarraj, MasterContact
Amani Al-Farraj, MasterPrincipal Investigator
Alanoud Aladel, PhdPrincipal Investigator