Obesity PreventionNCT06766747
Efficacy of Intermittent Fasting Versus Continuous Caloric Restriction in the Treatment of Significant Weight Regain After Bariatric Surgery
A study testing Intermittent Fasting and Continuous calorie restriction in people with Obesity Prevention and Bariatric Surgery Complications, run by Hospital Universitario San Ignacio at 1 site in Colombia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 69 years
- Conditions the study is for
- Obesity Prevention, Bariatric Surgery Complications, Intermittent Fasting
- What is being tested?
- Intermittent Fasting and Continuous calorie restriction
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 16 participants
- Where
- 1 siteColombia
- Study dates
- 19 Dec 2023to 30 Jun 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 69 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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, kidney disease, severe liver disease, or other illness that affects the ability to complete the study.
Trial locations and contacts
1 site in 1 country.
Colombia1 site
Hospital Universitario San Ignacio.
Bogotá, Bogota D.C., 111021
About this study
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?
Read more
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.
Read the detailed description
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).
Selection Period (Visit 0)
The bariatric surgery, nutrition, and endocrinology consultation of the bariatric clinic will identify possible candidates. In addition, the use of dietary supplements will be reviewed according to the Obesity Clinic's Clinical Practice Guide and the labs necessary to complete the baseline cardiometabolic profile will be obtained. A 7-day food recall and a record of usual physical activity and signing of informed consent will be required. In addition, an application will be downloaded to assess the number of steps per day taken by the individual to control for the physical activity variable.
Adjustment period (visit 1)
A visit with an obesity clinic dietitian will be scheduled 7 to 14 days after selection. During this visit, the 7-day recall will be reviewed to calculate basal weekly caloric intake. Baseline clinical and anthropometric data (weight, height, body mass index, abdominal circumference, and body composition) will be collected. Randomization will then be performed using a simple computer-generated randomization code, which will be managed centrally by a person who is unaware of the clinical characteristics of each patient outside the research group. The allocation made by this mechanism cannot be changed by the treating physicians. Subjects who do not attend the second visit or who do not properly complete the 7-day food and exercise diaries will be excluded. The order for the new metabolic profile will be generated to be performed at the end of the weight loss period.
Weight Loss Period
- Intervention Group (5:2): Participants in the alternate-day fasting group will receive bi-weekly nutritional counseling via telecounseling to ensure adherence to the prescribed dietary plan and to monitor for potential adverse events. During the 12-week weight loss phase, patients will be instructed to restrict their caloric intake to 75% of their usual intake 2 days per week. A daily intake of at least 2 liters of low-energy beverages (water, caffeine- and sugar-free beverages) is generally recommended on fasting days. Usual physical activity is encouraged to continue except on fasting days.
- Control group: Participants in the continuous caloric restriction group will receive biweekly nutritional counseling via telecounseling to ensure adherence to the prescribed dietary plan. Based on the weekly caloric consumption obtained from the 7-day record, a sample menu will be prescribed with a daily caloric restriction of 25%, divided into 3 meals per day, consisting of macronutrient intake with 20% of energy as fat, 40 to 50% as carbohydrate, and 20 to 30% as protein. The patient is instructed to continue normal physical activity.
At the end of the 12-week follow-up, visit 2 (V2) will be scheduled to obtain anthropometric data, body composition, and to review the cardiometabolic profile.
Maintenance period
At visit 2, patients who wish to discontinue intermittent fasting or continuous caloric restriction will be transitioned to a weight maintenance regimen which will be prescribed by a nutritionist from the obesity clinic. In addition, they will be recommended to continue physical activity, verify adherence to dietary supplements, and a follow-up will be scheduled in 12 weeks (visit 3) for anthropometric and cardiovascular profile monitoring.
Alternatively, patients in the intervention group who wish to continue will be prescribed a modified version of fasting. Energy intake on fasting days will be increased from 1000 to 1200 kcal. Similarly, in the continuous caloric restriction group, dietary caloric intake will be increased in a similar proportion. They will be recommended to continue physical activity, verify adherence to dietary supplements, and a follow-up will be scheduled in 12 weeks (visit 3) for anthropometric and cardiovascular profile monitoring.
Final measurements will be taken at week 24, after the two follow-up periods, so that all patients have the measurement at the same intervention time.
- Being tested
- Intermittent Fasting, Continuous calorie restriction
- Keywords
- Gain Weight Following Bariatric Surgery, Intermittent Fasting
- Medical subject headings
- Intermittent Fasting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intermittent FastingOther
Participants in the alternate-day fasting group will receive biweekly telecounseling to ensure adherence to the prescribed dietary plan and to monitor for potential adverse events. During the 12-week weight loss phase, patients are instructed to restrict calories to 75% of usual intake 2 days per week. A daily intake of at least 2 liters of low-energy beverages (water, caffeine- and sugar-free beverages) is generally recommended on fasting days. Usual physical activity is encourage
Continuous calorie restrictionOther
Participants in the continuous calorie restriction group will receive biweekly nutritional counseling via Telecoaching to ensure adherence to the prescribed dietary plan. Based on weekly caloric intake obtained from the 7-day log, a model menu will be prescribed with a 25% daily calorie restriction divided among 3 meals every day consisting of macronutrient intake, with 20% of energy as fat, 40 to 50% as carbohydrate, and 20 to 30% as protein. They will be instructed to continue their usual physical activity.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Active comparator | Participants in the alternate-day fasting group will receive biweekly telecounseling to ensure adherence to the prescribed dietary plan and to monitor for potential adverse events. During the 12-week weight loss phase, patients are instructed to restrict calories to 75% of usual intake 2 days per week. A daily intake of at least 2 liters of low-energy beverages (water, caffeine- and sugar-free beverages) is generally recommended on fasting days. Usual physical activity is encouraged to continue except on fasting days. Receives: Other: Intermittent Fasting |
| Control group | Placebo comparator | Participants in the continuous calorie restriction group will receive biweekly nutritional counseling via telecoaching to ensure adherence to the prescribed dietary plan. Based on the weekly caloric intake obtained from the 7-day log, a model menu will be prescribed with 25% daily caloric restriction divided into 3 meals per day consisting of macronutrient intake with 20% of energy as fat, 40 to 50% as carbohydrate, and 20 to 30% as protein. They are instructed to continue their usual physical activity. Receives: Other: Continuous calorie restriction |
What is being measured
The primary outcome is the main question the study is designed to answer.
Weight loss (Kg)
To evaluate the efficacy of intermittent fasting (5:2 diet) for 12 weeks, compared with continuous caloric restriction, in terms of weight reduction in kilograms (Kg), in patients with weight regain.
Measured: 12 weeks
Secondary outcomes (9)
Percentage of fat mass
To describe the change in percentage of fat mass measured at baseline and at 12 weeks of follow-up using the Seca mBCA 554 Medical Body Composition Analyzer.
Measured: 12 weeks
Visceral fat
To describe the change in visceral fat (VAT) measured at baseline and at 12 weeks of follow-up using the Seca mBCA 554 Medical Body Composition Analyzer.
Measured: 12 weeks
Percentage of lean mass
To describe the change in body composition percentage of lean mass measured at baseline and at 12 weeks of follow-up using the Seca mBCA 554 Medical Body Composition Analyzer.
Measured: 12 weeks
HbA1c
Compare changes in HbA1c after 12 weeks of follow-up between the intermittent fasting group and the continuous calorie restriction group.
Measured: 12 weeks
Weight 24 weeks
Compare changes in weight in kilograms after 24 weeks of follow-up.
Measured: 24 weeks
Percentage of fat mass 24 weeks
To describe the change in percentage of fat mass measured at baseline and at 24 weeks of follow-up using the Seca mBCA 554 Medical Body Composition Analyzer.
Measured: 24 weeks
Visceral fat 24 weeks
To describe the change in visceral fat (VAT) measured at baseline and at 24 weeks of follow-up using the Seca mBCA 554 Medical Body Composition Analyzer.
Measured: 24 weeks
Percentage of lean mass 24 weeks
To describe the change in body composition percentage of lean mass measured at baseline and at 24 weeks of follow-up using the Seca mBCA 554 Medical Body Composition Analyzer.
Measured: 24 weeks
HbA1c 24 weeks
Compare changes in HbA1c after 24 weeks of follow-up between the intermittent fasting group and the continuous calorie restriction group.
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2025
- Study start19 Dec 2023
- Primary completion31 Jan 2025
- Study completion30 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obesity PreventionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital Universitario San Ignacio
- Sponsor type
- University, hospital or other
- Collaborators
- Pontificia Universidad Javeriana
- Responsible party
- Sponsor
- Investigators
- Diana C Henao, Endocrinologyst, Principal investigator, Hospital Universitario San Ignacio
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06766747
- Sponsor's protocol ID
- FM-CIE-0622-23
- Status last verified
- Sep 2025
- First submitted
- 27 Dec 2024
- Last updated
- 25 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data are available from the authors if requested by the reader for research purposes.
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Intermittent Fasting Versus Continuous Caloric Restriction in the Treatment of Significant Weight Regain After Bariatric Surgery
- ClinicalTrials.gov ID
- NCT06766747
- Acronym / sponsor ID
- FM-CIE-0622-23
- Keywords
- Gain Weight Following Bariatric Surgery, Intermittent Fasting
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Hospital Universitario San IgnacioUniversity, hospital or other
- Collaborators
- Pontificia Universidad Javeriana
- Study start
- 19 Dec 2023 (actual)
- Primary completion
- 31 Jan 2025 (actual)
- Study completion
- 30 Jun 2025 (actual)
- First posted
- 9 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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).
Selection Period (Visit 0)
The bariatric surgery, nutrition, and endocrinology consultation of the bariatric clinic will identify possible candidates. In addition, the use of dietary supplements will be reviewed according to the Obesity Clinic's Clinical Practice Guide and the labs necessary to complete the baseline cardiometabolic profile will be obtained. A 7-day food recall and a record of usual physical activity and signing of informed consent will be required. In addition, an application will be downloaded to assess the number of steps per day taken by the individual to control for the physical activity variable.
Adjustment period (visit 1)
A visit with an obesity clinic dietitian will be scheduled 7 to 14 days after selection. During this visit, the 7-day recall will be reviewed to calculate basal weekly caloric intake. Baseline clinical and anthropometric data (weight, height, body mass index, abdominal circumference, and body composition) will be collected. Randomization will then be performed using a simple computer-generated randomization code, which will be managed centrally by a person who is unaware of the clinical characteristics of each patient outside the research group. The allocation made by this mechanism cannot be changed by the treating physicians. Subjects who do not attend the second visit or who do not properly complete the 7-day food and exercise diaries will be excluded. The order for the new metabolic profile will be generated to be performed at the end of the weight loss period.
Weight Loss Period
- Intervention Group (5:2): Participants in the alternate-day fasting group will receive bi-weekly nutritional counseling via telecounseling to ensure adherence to the prescribed dietary plan and to monitor for potential adverse events. During the 12-week weight loss phase, patients will be instructed to restrict their caloric intake to 75% of their usual intake 2 days per week. A daily intake of at least 2 liters of low-energy beverages (water, caffeine- and sugar-free beverages) is generally recommended on fasting days. Usual physical activity is encouraged to continue except on fasting days.
- Control group: Participants in the continuous caloric restriction group will receive biweekly nutritional counseling via telecounseling to ensure adherence to the prescribed dietary plan. Based on the weekly caloric consumption obtained from the 7-day record, a sample menu will be prescribed with a daily caloric restriction of 25%, divided into 3 meals per day, consisting of macronutrient intake with 20% of energy as fat, 40 to 50% as carbohydrate, and 20 to 30% as protein. The patient is instructed to continue normal physical activity.
At the end of the 12-week follow-up, visit 2 (V2) will be scheduled to obtain anthropometric data, body composition, and to review the cardiometabolic profile.
Maintenance period
At visit 2, patients who wish to discontinue intermittent fasting or continuous caloric restriction will be transitioned to a weight maintenance regimen which will be prescribed by a nutritionist from the obesity clinic. In addition, they will be recommended to continue physical activity, verify adherence to dietary supplements, and a follow-up will be scheduled in 12 weeks (visit 3) for anthropometric and cardiovascular profile monitoring.
Alternatively, patients in the intervention group who wish to continue will be prescribed a modified version of fasting. Energy intake on fasting days will be increased from 1000 to 1200 kcal. Similarly, in the continuous caloric restriction group, dietary caloric intake will be increased in a similar proportion. They will be recommended to continue physical activity, verify adherence to dietary supplements, and a follow-up will be scheduled in 12 weeks (visit 3) for anthropometric and cardiovascular profile monitoring.
Final measurements will be taken at week 24, after the two follow-up periods, so that all patients have the measurement at the same intervention time.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Active comparator | Other: Intermittent FastingParticipants in the alternate-day fasting group will receive biweekly telecounseling to ensure adherence to the prescribed dietary plan and to monitor for potential adverse events. During the 12-week weight loss phase, patients are instructed to restrict calories to 75% of usual intake 2 days per week. A daily intake of at least 2 liters of low-energy beverages (water, caffeine- and sugar-free beverages) is generally recommended on fasting days. Usual physical activity is encouraged to continue except on fasting days. |
| Control group | Placebo comparator | Other: Continuous calorie restrictionParticipants in the continuous calorie restriction group will receive biweekly nutritional counseling via telecoaching to ensure adherence to the prescribed dietary plan. Based on the weekly caloric intake obtained from the 7-day log, a model menu will be prescribed with 25% daily caloric restriction divided into 3 meals per day consisting of macronutrient intake with 20% of energy as fat, 40 to 50% as carbohydrate, and 20 to 30% as protein. They are instructed to continue their usual physical activity. |
Who may qualify
- Ages
- 18 to 69 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intermittent FastingParticipants in the alternate-day fasting group will receive biweekly telecounseling to ensure adherence to the prescribed dietary plan and to monitor for potential adverse events. During the 12-week weight loss phase, patients are instructed to restrict calories to 75% of usual intake 2 days per week. A daily intake of at least 2 liters of low-energy beverages (water, caffeine- and sugar-free beverages) is generally recommended on fasting days. Usual physical activity is encourage | Other | Intervention group |
| Continuous calorie restrictionParticipants in the continuous calorie restriction group will receive biweekly nutritional counseling via Telecoaching to ensure adherence to the prescribed dietary plan. Based on weekly caloric intake obtained from the 7-day log, a model menu will be prescribed with a 25% daily calorie restriction divided among 3 meals every day consisting of macronutrient intake, with 20% of energy as fat, 40 to 50% as carbohydrate, and 20 to 30% as protein. They will be instructed to continue their usual physical activity. | Other | Control group |
Primary outcome
Weight loss (Kg)
Time frame: 12 weeks
To evaluate the efficacy of intermittent fasting (5:2 diet) for 12 weeks, compared with continuous caloric restriction, in terms of weight reduction in kilograms (Kg), in patients with weight regain.
9 secondary outcomes
Percentage of fat mass
Time frame: 12 weeks
Visceral fat
Time frame: 12 weeks
Percentage of lean mass
Time frame: 12 weeks
HbA1c
Time frame: 12 weeks
Weight 24 weeks
Time frame: 24 weeks
Percentage of fat mass 24 weeks
Time frame: 24 weeks
Visceral fat 24 weeks
Time frame: 24 weeks
Percentage of lean mass 24 weeks
Time frame: 24 weeks
HbA1c 24 weeks
Time frame: 24 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2025.
- Individual participant dataSharing planned: Yes. The data are available from the authors if requested by the reader for research purposes.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Diana C Henao, Endocrinologyst principal investigator
Hospital Universitario San Ignacio
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intermittent Fasting and Continuous calorie restriction in people with Obesity Prevention and Bariatric Surgery Complications, run by Hospital Universitario San Ignacio at 1 site in Colombia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Colombia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Weight loss (Kg) (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Sep 2025.