Efficacy of Intermittent Fasting Versus Continuous Caloric Restriction in the Treatment of Signif… (NCT06766747) | Clinical Trial Compass
CompletedNot Applicable
Efficacy of Intermittent Fasting Versus Continuous Caloric Restriction in the Treatment of Significant Weight Regain After Bariatric Surgery
Colombia16 participantsStarted 2023-12-19
Plain-language summary
Intermittent fasting has gained relevance in recent years because it allows for significant weight loss with improvement in cardiovascular risk factors similar to calorie-restricted diets without people having to track calories every day, or prohibiting people from eating certain food groups. However, there is no data about its usefulness in patients with weight gain after bariatric surgery, or its long-term effects(9).
Research question: In patients with weight gain, being followed up in the obesity clinic, is intermittent fasting for 12 weeks, compared to calorie restriction, effective in terms of weight reduction?
H0: Change in weight from baseline to 12 weeks less than 5% H1: Change in weight from baseline to 12 weeks greater than or equal to 5%
Patients meeting the inclusion criteria will be identified. Once identified, they will be asked to participate in the study and, if they accept, they will be asked to complete and sign the informed consent form. The study will consist of three phases: a selection phase, an adaptation phase (1 to 2 weeks), a weight loss phase (12 weeks) and a maintenance phase (12 weeks).
At the first visit, patients will be randomized to two types of nutritional interventions: intermittent fasting or caloric restriction. During the weight loss phase, biweekly follow-up will be performed to ensure adherence to the assigned dietary intervention. At the end of the 12 weeks, patients can decide whether to continue the assigned dietary intervention or move to a maintenance plan. Anthropometric measurements and body composition will be measured at baseline, 12 and 24 weeks.
Who can participate
Age range
18 Years – 69 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Patients between 18 and 69 years of age treated with primary and/or secondary bariatric surgery with more than 1 year of postoperative.
2.3.3 INCLUSION CRITERIA
* 10% weight gain with respect to the minimum postoperative weight and/or
* Weight gain rate ≥0.50% with respect to previous weight.
* Supplementation with ferrous sulfate, cyanocobalamin and cholecalciferol, according to clinical criteria.
* Not having modified the therapy in the last 3 months
* Access to mobile phone with data.
* Agree to participate in the study including signing informed consent.
2.3.4 EXCLUSION CRITERIA.
* Patient diagnosed with type 1 diabetes mellitus.
* Patient diagnosed with type 2 diabetes mellitus treated with insulin.
* History of an eating disorder such as anorexia or bulimia. • Untreated vitamin B12, iron, calcium, and/or vitamin D deficiency.
* History of hospitalization for cardiovascular disease (angina, myocardial infarction, or stroke) 3 months prior to the study.
* Use of antidepressant or anti-anxiety medications
* Use of medications that affect the results of the study (weight loss medications)
* Unable to keep a food diary or activity log for 7 consecutive days during screening
* Cognitive impairment that, in the opinion of the principal investigator or study physician, would result in failure to cooperate with study procedures.
* Active neoplastic disease.
* Pregnancy or breast-feeding, or planning to become pregnant during the study period
* Significant psychiatric illness…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.