NCT06766747Befejeződött
Efficacy of Intermittent Fasting Versus Continuous Caloric Restriction in the Treatment of Significant Weight Regain After Bariatric Surgery
Forrás: ClinicalTrials.gov · Utoljára frissítve: 2025. szept. 25.
Rövid összefoglaló (regiszter, angolul)
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.
- Állapot (regiszter)
- Befejeződött
- Vizsgálattípus
- Beavatkozással járó
- Résztvevők száma
- 16 (tényleges)
- Első benyújtás
- 2024. dec. 27.
- Kezdés
- 2023. dec. 19.
- Elsődleges befejezés
- 2025. jan. 31.
- Fő szponzor
- Hospital Universitario San Ignacio
- Betegségek
- Elhízás
- NCT-szám
- NCT06766747
Mit vállalsz
- Vizsgálat típusa: Beavatkozással járó
- Bevont résztvevők: 16
- 2023. dec. 19. és az elsődleges befejezés (2025. jan. 31.) között
- 1 helyszín, 1 országban
- Vizitek és vizsgálatok: kérdezd a vizsgálat csapatát, a regiszter nem sorolja fel őket
A(z) ClinicalTrials.gov regisztermezőiből összeállítva. A vizsgálat felépítését írja le.
Ki nem vehet részt
Szó szerint a(z) ClinicalTrials.gov forrásból, témák szerint csoportosítva. Hogy ki vehet részt, azt csak a vizsgálat csapata dönti el.
A regiszterben nem jelölt feltételek
- 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.
Életkor a regiszterben: 18 év – 69 év · Nem: nők és férfiak · Egészséges önkénteseket nem fogad
Helyszínek (1)
Helyszínek a regiszter sorrendjében. Ha a profilodba mented a városodat, távolság szerint rendeződnek.
| Helyszín | Város | Ország | Helyszín állapota |
|---|---|---|---|
| Hospital Universitario San Ignacio | Bogotá | Kolumbia | Ismeretlen állapot |
Ez az oldal tájékoztatás, nem orvosi tanács. Bármely vizsgálatról az orvosoddal beszélj.