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
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 246
- 试验地点
- 1
- 主要终点
- Change in weight maintenance and insulin sensitivity
研究概览
简要总结
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.
详细描述
Bariatric surgery is the most effective treatment for severe obesity and often induces remission of comorbidities. However, up to 50-70% of patients experience weight recurrence and metabolic relapse within four years, suggesting that there must be adjunct strategies to sustain benefits. Circadian biology, the alignment of internal rhythms with behaviors such as eating and sleep, has emerged as a modifiable determinant of weight regulation, glycemic control, appetite, and inflammation. Chrononutrition, characterized by the deliberate scheduling of meals to correspond with circadian physiology, may present an innovative approach for long-term post-bariatric management. Early time-restricted eating (eTRE) has improved weight and metabolic outcomes in non-surgical populations. Post-bariatric patients may additionally benefit through improved hunger/satiety signaling, circadian alignment, favorable microbiota shifts, and possible epigenetic regulation. Despite this promise, randomized controlled evidence in post-bariatric cohorts is lacking.
Rationale and Significance This study addresses a major gap by evaluating whether chrononutrition tailored to chronotype improves long-term metabolic, microbial, and behavioral outcomes after bariatric surgery. Findings may reduce weight regain, enhance glycemic control, optimize gut microbiota composition, and offer information about circadian-epigenetic mechanisms. Results could inform future clinical practice guidelines and integrate precision nutrition into bariatric care.
Study Aim and Objectives The primary aim is to evaluate the effect of chronotype-based chrononutrition on metabolic, microbial, epigenetic, and behavioral outcomes in post-bariatric patients.
Primary Objective: Assess whether chronotype-based meal timing improves weight maintenance, insulin sensitivity, and gut microbiota diversity compared with standard care and generic eTRE.
Secondary Objectives: Examine effects on circadian gene expression, DNA methylation and histone modifications, gut hormones (GLP-1, PYY, ghrelin), eating behavior, sleep, mood, and physical activity. Explore microbiota and epigenetic mediation of outcomes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
Due to the behavioral nature of the dietary interventions, participants and care providers cannot be blinded. However, outcome assessors, including laboratory personnel and data analysts, will remain blinded to group allocation to minimize detection and analysis bias.
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •• 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.
研究组 & 干预措施
Standard Post-Bariatric Care
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.
干预措施: Standard Post-Bariatric Care (Control) (Behavioral)
Early Time-Restricted Eating (eTRE)
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.
干预措施: Early Time-Restricted Eating (eTRE) (Behavioral)
Chronotype-Based Chrono-Nutrition (CB-CN)
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.
干预措施: Chronotype-Based Chrono-Nutrition (CB-CN) (Behavioral)
结局指标
主要结局
Change in weight maintenance and insulin sensitivity
时间窗: Baseline, 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.
次要结局
- Change in gut microbiota diversity and composition(Baseline, 6, 12 months)
- Change in inflammatory markers and lipid profile(Baseline, 6, 12 months)
- Change in circadian gene expression and epigenetic markers(Baseline, 3, 6, 12 months)
- Change in gut-derived hormones(Baseline and 12 months)
研究者
Amani Al-Farraj
Ms.
King Saud University