Ignite Creation Date:
2025-12-18 @ 9:30 AM
Ignite Modification Date:
2025-12-23 @ 8:39 PM
Study NCT ID:
NCT06766747
Status:
None
Last Update Posted:
2025-09-25 00:00:00
First Post:
2024-12-27 00:00:00
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Efficacy of Intermittent Fasting Versus Continuous Caloric Restriction in the Treatment of Significant Weight Regain After Bariatric Surgery
Sponsor:
None
Organization:
Study Overview
Official Title:
Efficacy of Intermittent Fasting Versus Continuous Caloric Restriction in the Treatment of Significant Weight Regain After Bariatric Surgery
Status:
None
Status Verified Date:
2025-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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.
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.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: