Bariatric SurgeryAFMS_FOODNCT06205017
Post-bariatric Surgery Weaning With Food for Special Medical Purposes to Increase Patient Compliance.
A study testing Foods for Special Medical Purposes in people with Bariatric Surgery, run by I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio.
Trial summary
Due to the reduced volume and postoperative gastric edema, ingestion of solid foods in the first few days after surgery is very difficult or impossible; following bariatric surgery there are anatomical changes in the vagus that may contribute to the alteration of taste perception. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Bariatric Surgery
- What is being tested?
- Foods for Special Medical Purposes
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- No sites listed yet
- Study dates
- 9 Jan 2024to 9 Aug 2024
- 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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Age ≥18 and ≤ of 60
- Subjects with severe or morbid obesity (BMI ≥ 35 kg/m2 in the presence of comorbidities and BMI ≥ 40 kg/m2)
- Absence of diagnosis of primary obesity
- Absence of medical/psychiatric contraindications
- Signature of informed consent for the study
- Patients who are candidates by clinical practice for bariatric surgery (Sleeve Gastrectomy and Roux-en-Y Gastric Bypass).
Who cannot join
- Presence of chronic diseases of the digestive system, such as chronic diseases intestinal, malabsorption syndrome, diverticulosis of the colon
- Current pregnancy (verified by self-declaration) and/or lactation
- Subjects with endocrine disorders (e.g., Cushing's m., thyroid disease uncontrolled)
- Presence of known renal insufficiency or creatinine levels greater than 1.8 mg/dl and eGFR < 60 ml/min
- Presence of malignant pathology
- Alcohol or drug abuse
- Severe psychological/psychiatric disorders
- Difficulty adhering to the protocol due to language barriers or other reasons.
About this study
Official title: Use of New Food Products (Food for Special Medical Purposes) in the Period Post-bariatric Surgery Weaning to Increase Patient Compliance Diet and Avoid Nutritional Deficiencies.
Due to the reduced volume and postoperative gastric edema, ingestion of solid foods in the first few days after surgery is very difficult or impossible; following bariatric surgery there are anatomical changes in the vagus that may contribute to the alteration of taste perception. In order to facilitate patient weaning and improve the liking of the foods used in this semi-liquid phase, our Center intends to test some "Foods for Special Medical Purposes" (AFMS), in order to ensure a better intake of nutrition, including in terms of vitamin D3 and calcium, good palatability and thus a better adherence to the recommended nutritional indications in the immediate postoperative period than the homogenized foods used in the standard diet.
Read the detailed description
Primary goal: Patient compliance throughout the weaning period (4 weeks postintervention), assessed through product liking measurable by Sensory Questionnaire.
Secondary objective:
- Patient compliance throughout the weaning period (4 weeks postintervention), assessed through product liking measurable with test comparative
- Taste perception, liking, palatability and food preferences among the different products (Special Medical Purpose Foods-AFMS vs homogenized foods) and between pre and post bariatric surgery.
- Nutritional efficacy (assessment of blood levels of micronutrients such as. iron, ferritin, transferrin , calcium, vit D3, folic ac, vit B12 and of macronutrients such as total protein and protein electrophoresis; bioimpedance analysis for body composition assessment). 32 subjects with severe or morbid obesity ( BMI ≥ 35 kg/m2 in the presence of comorbidities and BMI ≥ 40 kg/m2 , respectively), male and female, candidates for bariatric surgery (Sleeve Gastrectomy and Roux-en-Y Gastric Bypass).
Two timepoints: T0 (pre-rev) and T1 (follow-up 1 month +/-7 days). Planned assessments at T0 and T1.
- Administration of the sensory questionnaire.
- Comparative test
- Hematochemical tests: iron, ferritin, transferrin, , vit D3, ac. Folic, vit B12 and macronutrients such as total protein + general hematochemicals (complete blood count complete, protein electrophoresis, AST, ALT, gamma GT, creatininemia, azotemia, col tot, HDL, LDL, triglycerides, blood glucose).
- Analysis of taste perception and variation by Taste Strips.
- Bioimpedance analysis (BIA)
- Anthropometric evaluations
- Conditions
- Bariatric Surgery
- Being tested
- Foods for Special Medical Purposes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Foods for Special Medical PurposesDietary supplement
In order to facilitate patient weaning and to improve the enjoyment of foods used in this semi-liquid phase, our Center intends to test "Foods for Special Medical Purposes" (AFMS) to ensure better nutritional intake, including vitamin D3 and calcium, good palatability, and thus better adherence to the recommended nutritional indications in the immediate postoperative period than the homogenized foods used in the standard diet.
| Study group | Role | What they receive |
|---|---|---|
| Group A (AFSM) | Experimental | 16 subjects (Group A: intervention group) will take AFSMs in the immediate postoperative period (Appendix A). A weaning period with AFSM nutritional protocol of 4 weeks is planned, the weaning will cover the entire observation period T0 → T1. Receives: Dietary Supplement: Foods for Special Medical Purposes |
| Group B (protocol in use with homogenized) | No intervention | 16 subjects (Group B: control group) will follow the standard weaning protocol i.e. with homogenized food (Appendix B). A weaning period with nutritional protocol, as per clinical protocol, of 4 weeks is planned, weaning will cover the entire observation period T0 → T1. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient compliance throughout the weaning period
Patient compliance throughout the weaning period (4 weeks post-intervention), assessed through satisfaction with the products measurable with a questionnaire sensory.
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2024
- Study start9 Jan 2024 (estimated)
- Primary completion9 Jul 2024 (estimated)
- Study completion9 Aug 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bariatric SurgeryStudies of the same condition, open and under way.
- More trials run by I.R.C.C.S Ospedale Galeazzi-Sant'AmbrogioThe sponsor's other registered studies.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The sample size was calculated in order to identify differences significant in the increase of liking in the study group compared with the control. According to the PI's experience, the frequency of liking in the group control is 5% and this is expected to increase to 70% in the study group. Considering using a Fisher's exact test with alpha level=0.05, to obtain a power of 95%, 14 patients per group are needed. This number is increased by 10% in case of possible dropouts, for a total of 16 subjects per group and 32 total.
- Masking
- None (open label)
- Enrolment
- 32 participants (estimated)
Sponsor and investigators
- Lead sponsor
- I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06205017
- Sponsor's protocol ID
- AFMS_FOOD (L4190)
- Acronym
- AFMS_FOOD
- Status last verified
- Dec 2023
- First submitted
- 18 Dec 2023
- Last updated
- 12 Jan 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of New Food Products (Food for Special Medical Purposes) in the Period Post-bariatric Surgery Weaning to Increase Patient Compliance Diet and Avoid Nutritional Deficiencies.
- ClinicalTrials.gov ID
- NCT06205017
- Acronym / sponsor ID
- AFMS_FOOD / AFMS_FOOD (L4190)
- Conditions
- Bariatric Surgery
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 32 participants (estimated)
- Lead sponsor
- I.R.C.C.S Ospedale Galeazzi-Sant'AmbrogioUniversity, hospital or other
- Study start
- 9 Jan 2024 (estimated)
- Primary completion
- 9 Jul 2024 (estimated)
- Study completion
- 9 Aug 2024 (estimated)
- First posted
- 12 Jan 2024 (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.
Due to the reduced volume and postoperative gastric edema, ingestion of solid foods in the first few days after surgery is very difficult or impossible; following bariatric surgery there are anatomical changes in the vagus that may contribute to the alteration of taste perception. In order to facilitate patient weaning and improve the liking of the foods used in this semi-liquid phase, our Center intends to test some "Foods for Special Medical Purposes" (AFMS), in order to ensure a better intake of nutrition, including in terms of vitamin D3 and calcium, good palatability and thus a better adherence to the recommended nutritional indications in the immediate postoperative period than the homogenized foods used in the standard diet.
Detailed description
Primary goal: Patient compliance throughout the weaning period (4 weeks postintervention), assessed through product liking measurable by Sensory Questionnaire.
Secondary objective:
- Patient compliance throughout the weaning period (4 weeks postintervention), assessed through product liking measurable with test comparative
- Taste perception, liking, palatability and food preferences among the different products (Special Medical Purpose Foods-AFMS vs homogenized foods) and between pre and post bariatric surgery.
- Nutritional efficacy (assessment of blood levels of micronutrients such as. iron, ferritin, transferrin , calcium, vit D3, folic ac, vit B12 and of macronutrients such as total protein and protein electrophoresis; bioimpedance analysis for body composition assessment). 32 subjects with severe or morbid obesity ( BMI ≥ 35 kg/m2 in the presence of comorbidities and BMI ≥ 40 kg/m2 , respectively), male and female, candidates for bariatric surgery (Sleeve Gastrectomy and Roux-en-Y Gastric Bypass).
Two timepoints: T0 (pre-rev) and T1 (follow-up 1 month +/-7 days). Planned assessments at T0 and T1.
- Administration of the sensory questionnaire.
- Comparative test
- Hematochemical tests: iron, ferritin, transferrin, , vit D3, ac. Folic, vit B12 and macronutrients such as total protein + general hematochemicals (complete blood count complete, protein electrophoresis, AST, ALT, gamma GT, creatininemia, azotemia, col tot, HDL, LDL, triglycerides, blood glucose).
- Analysis of taste perception and variation by Taste Strips.
- Bioimpedance analysis (BIA)
- Anthropometric evaluations
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The sample size was calculated in order to identify differences significant in the increase of liking in the study group compared with the control. According to the PI's experience, the frequency of liking in the group control is 5% and this is expected to increase to 70% in the study group. Considering using a Fisher's exact test with alpha level=0.05, to obtain a power of 95%, 14 patients per group are needed. This number is increased by 10% in case of possible dropouts, for a total of 16 subjects per group and 32 total.
| Arm | Type | Receives |
|---|---|---|
| Group A (AFSM) | Experimental | Dietary Supplement: Foods for Special Medical Purposes16 subjects (Group A: intervention group) will take AFSMs in the immediate postoperative period (Appendix A). A weaning period with AFSM nutritional protocol of 4 weeks is planned, the weaning will cover the entire observation period T0 → T1. |
| Group B (protocol in use with homogenized) | No intervention | –16 subjects (Group B: control group) will follow the standard weaning protocol i.e. with homogenized food (Appendix B). A weaning period with nutritional protocol, as per clinical protocol, of 4 weeks is planned, weaning will cover the entire observation period T0 → T1. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Age ≥18 and ≤ of 60
- Subjects with severe or morbid obesity (BMI ≥ 35 kg/m2 in the presence of comorbidities and BMI ≥ 40 kg/m2)
- Absence of diagnosis of primary obesity
- Absence of medical/psychiatric contraindications
- Signature of informed consent for the study
Key exclusion criteria (8 listed)
- Presence of chronic diseases of the digestive system, such as chronic diseases intestinal, malabsorption syndrome, diverticulosis of the colon
- Current pregnancy (verified by self-declaration) and/or lactation
- Subjects with endocrine disorders (e.g., Cushing's m., thyroid disease uncontrolled)
- Presence of known renal insufficiency or creatinine levels greater than 1.8 mg/dl and eGFR < 60 ml/min
- Presence of malignant pathology
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 |
|---|---|---|
| Foods for Special Medical PurposesIn order to facilitate patient weaning and to improve the enjoyment of foods used in this semi-liquid phase, our Center intends to test "Foods for Special Medical Purposes" (AFMS) to ensure better nutritional intake, including vitamin D3 and calcium, good palatability, and thus better adherence to the recommended nutritional indications in the immediate postoperative period than the homogenized foods used in the standard diet. | Dietary supplement | Group A (AFSM) |
Primary outcome
Patient compliance throughout the weaning period
Time frame: 1 month
Patient compliance throughout the weaning period (4 weeks post-intervention), assessed through satisfaction with the products measurable with a questionnaire sensory.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jan 2024.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Foods for Special Medical Purposes in people with Bariatric Surgery, run by I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. 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: status not confirmed, as of the sponsor's last update on 12 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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?
Results are not available in the source record.
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?
Patient compliance throughout the weaning period (time frame: 1 month). 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 12 Jan 2024.