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NUTritional Impact of a Hypocaloric Hyperprotein Diet Before Obesity Surgery (NUTRACOB)

Primary Purpose

Diet, Healthy, Obesity, Visceral, Bariatric Surgery Candidate

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
With low-calorie, high-protein diet
Without low-calorie, high-protein diet
Sponsored by
University Hospital, Rouen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Diet, Healthy focused on measuring diet, obesity, bariatric surgery

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patient eligible for bariatric surgery (according to HAS criteria) whose sleeve gastrectomy is scheduled
  • Patient with morbid obesity (BMI ≥ 40)
  • Age ≥ 18 years and ≤ 65 years
  • Haemoglobinemia ≥ 12 g/dL in men and ≥ 11 g/dL in women
  • Patient speaking and understanding French
  • Adult having read and understood the information letter and signed the consent form
  • Woman of childbearing age with effective / very effective contraception (Cf. CTFG) (estrogen-progestin or intrauterine device or tubal ligation) prior to surgery and a negative -HCG blood pregnancy test at inclusion, for the duration of the study
  • Postmenopausal woman: confirmatory diagnosis (non-medically induced amenorrhoea for at least 12 months prior to the inclusion visit)
  • Patient affiliated with, or beneficiary of a social security (health insurance) category

Exclusion Criteria:

  • Contraindication to bariatric surgery detected during the preoperative assessment
  • Medical contraindication to a restrictive diet
  • Type I or II insulin-requiring diabetes
  • Severe renal insufficiency defined by a blood filtration rate < 30 mL/min
  • Person wearing a pacemaker or any other implant with the same functions (cochlear implant, bladder battery, etc.)
  • Person deprived of liberty by an administrative or judicial decision or person placed under judicial protection / sub-guardianship or curatorship
  • A history of illness or psychological or sensory abnormality likely to prevent the subject from fully understanding the conditions required for participation in the protocol or to prevent him/her from giving informed consent

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Other

    Arm Label

    With diet

    Without diet

    Arm Description

    A low-calorie, high-protein diet will be prescribed to the patient for a period of 4 weeks. The diet will be done the 4 weeks before the bariatric surgery

    A low-calorie, high-protein diet will not be prescribed to the patient for a period of 4 weeks.

    Outcomes

    Primary Outcome Measures

    Poor diet tolerance
    At least one of the following biological abnormalities at the end of the diet period: Lymphopenia acquired during the diet Anemia (Hb<11g/dL for men Hb<10g/dL for women) or a decrease in hemoglobin of more than 2 g/dL Onset or worsening of vitamin B1 deficiency from baseline (Vit B1 < 78 nmol/L) OR At least one of the following clinical abnormalities: Decrease in muscle strength (difference in muscle strength measured with a HandGrip at Visit 2 and Visit 3) greater than three standard deviations from the matched Visit 3 - visit 2 differences of the control group after removal of measurement bias on a log-transformed strength variable, associated with weight loss > 5% in 1 month or a decrease in percent lean mass ≥ 1% relative to visit 2 Any permanent discontinuation

    Secondary Outcome Measures

    Weight loss
    Weight difference between Visit 3 and Visit 2
    Reduced muscle strength
    Difference in muscle strength measured with a HandGrip at Visit 2 and Visit 3)
    Comparison of the quality of life between "with diet" and "without diet" with "EQVOD" questionnaire
    Evaluated using the EQVOD questionnaire at baseline (V2), end of diet (V3) and 3 months postoperatively Score from 36 to 180
    Evolution of physical activity
    Physical activity evaluated using the Ricci et Gagnon questionnaire at baseline (V2), end of diet (V3) and 3 months postoperatively
    Digestive tolerance
    Digestive tolerance evaluated using auto-questionnaire about nausea, vomiting, diarrhoea, constipation forthe interventional group, in the month of the diet
    Compliance
    Evaluated by a food diary and the full bottles (not consumed) brought back for the intervention group, in the month of the diet
    Degree of exposure
    Assessment of the degree of exposure of the oesogastric junction and hepatomegaly on a subjective scale of 1 to 5 by the surgeon
    Operating time
    Number of hours and minuts about surgery
    Length of hospital stay
    Number of days in hospital for the surgery
    Intraoperative and postoperative complications
    Delayed healing, infection and cancellation of surgery or conversion to laparotomy) up to 3 months post-operatively

    Full Information

    First Posted
    June 11, 2021
    Last Updated
    March 9, 2023
    Sponsor
    University Hospital, Rouen
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04942093
    Brief Title
    NUTritional Impact of a Hypocaloric Hyperprotein Diet Before Obesity Surgery
    Acronym
    NUTRACOB
    Official Title
    NUTritional Impact of a Hypocaloric Hyperprotein Diet Before Obesity Surgery
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    May 1, 2023 (Anticipated)
    Primary Completion Date
    November 1, 2024 (Anticipated)
    Study Completion Date
    May 1, 2025 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    University Hospital, Rouen

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    Obesity is a major public health problem and is constantly on the rise. Therapeutic approaches based on dietary advice, physical activity and the management of psychological difficulties are not always sufficient to achieve a lasting weight reduction. Bariatric surgery (or obesity surgery), accompanied by therapeutic education and adequate medical and dietary monitoring, can lead to significant and lasting weight loss. It is indicated as a second-line treatment for patients who have failed medical treatment, whose BMI is greater than or equal to 40 or whose BMI is greater than or equal to 35 with comorbidities (type 2 diabetes, arterial hypertension, obstructive sleep apnoea-hypopnoea syndrome, severe joint disorders). The surgeon may be very bothered by the intra-abdominal fat mass and especially by steatotic hepatomegaly (increase in the size of the liver and its fat load). Faced with this problem, various preoperative strategies such as the placement of an intra gastric balloon have been tried to decrease the size of the liver but a systematic review from 2016 indicates that a low calorie diet is preferable. Preoperative weight loss can reduce fat load and liver volume very rapidly. This meta-analysis shows that all low-calorie, high-protein diets are effective and that the optimal duration (4 weeks), compliance and tolerance are important factors for success.
    Detailed Description
    Obesity is a major public health problem and is constantly on the rise. Therapeutic approaches based on dietary advice, physical activity and the management of psychological difficulties are not always sufficient to achieve a lasting weight reduction. Bariatric surgery (or obesity surgery), accompanied by therapeutic education and adequate medical and dietary monitoring, can lead to significant and lasting weight loss. It is indicated as a second-line treatment for patients who have failed medical treatment, whose BMI is greater than or equal to 40 or whose BMI is greater than or equal to 35 with comorbidities (type 2 diabetes, arterial hypertension, obstructive sleep apnoea-hypopnoea syndrome, severe joint disorders). The surgeon may be very bothered by the intra-abdominal fat mass and especially by steatotic hepatomegaly (increase in the size of the liver and its fat load). Faced with this problem, various preoperative strategies such as the placement of an intra gastric balloon have been tried to decrease the size of the liver but a systematic review from 2016 indicates that a low calorie diet is preferable. Preoperative weight loss can reduce fat load and liver volume very rapidly. This meta-analysis shows that all low-calorie, high-protein diets are effective and that the optimal duration (4 weeks), compliance and tolerance are important factors for success. However, there is no consensus on the benefit/risk balance of a preoperative diet and there is considerable variability in approach at national and international level. The present clinical study involves a triad of dietician, surgeon, physician (endocrinologist/nutritionist or internist) to secure this diet. It could provide a database to help estimate the risk of undernutrition in the obese subject. This diet, designed to facilitate the surgical procedure and potentially reduce intraoperative complications, is inexpensive, easily accessible and reproducible by other teams. This innovative management could standardise the preoperative management of patients undergoing bariatric surgery at national level. It would also improve the results of bariatric surgery both in the short term by reducing complications and in the long term by increasing weight reduction as reported in the Livhits meta-analysis. The risk of undernutrition should be reduced by this hypocaloric hyperprotein diet and consequently cancel out the increased risk of mortality, infections, delayed healing, longer hospital stay and the costs that this would entail.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Diet, Healthy, Obesity, Visceral, Bariatric Surgery Candidate
    Keywords
    diet, obesity, bariatric surgery

    7. Study Design

    Primary Purpose
    Supportive Care
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    200 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    With diet
    Arm Type
    Experimental
    Arm Description
    A low-calorie, high-protein diet will be prescribed to the patient for a period of 4 weeks. The diet will be done the 4 weeks before the bariatric surgery
    Arm Title
    Without diet
    Arm Type
    Other
    Arm Description
    A low-calorie, high-protein diet will not be prescribed to the patient for a period of 4 weeks.
    Intervention Type
    Dietary Supplement
    Intervention Name(s)
    With low-calorie, high-protein diet
    Intervention Description
    A low-calorie, high-protein diet will be prescribed to the patient for a period of 4 weeks. The diet will be done the 4 weeks before the bariatric surgery
    Intervention Type
    Dietary Supplement
    Intervention Name(s)
    Without low-calorie, high-protein diet
    Intervention Description
    A low-calorie, high-protein diet will not be prescribed to the patient for a period of 4 weeks.
    Primary Outcome Measure Information:
    Title
    Poor diet tolerance
    Description
    At least one of the following biological abnormalities at the end of the diet period: Lymphopenia acquired during the diet Anemia (Hb<11g/dL for men Hb<10g/dL for women) or a decrease in hemoglobin of more than 2 g/dL Onset or worsening of vitamin B1 deficiency from baseline (Vit B1 < 78 nmol/L) OR At least one of the following clinical abnormalities: Decrease in muscle strength (difference in muscle strength measured with a HandGrip at Visit 2 and Visit 3) greater than three standard deviations from the matched Visit 3 - visit 2 differences of the control group after removal of measurement bias on a log-transformed strength variable, associated with weight loss > 5% in 1 month or a decrease in percent lean mass ≥ 1% relative to visit 2 Any permanent discontinuation
    Time Frame
    4 weeks after the beggining of the diet
    Secondary Outcome Measure Information:
    Title
    Weight loss
    Description
    Weight difference between Visit 3 and Visit 2
    Time Frame
    4 weeks after the beggining of the diet and 3 months postoperatively
    Title
    Reduced muscle strength
    Description
    Difference in muscle strength measured with a HandGrip at Visit 2 and Visit 3)
    Time Frame
    4 weeks after the beggining of the diet
    Title
    Comparison of the quality of life between "with diet" and "without diet" with "EQVOD" questionnaire
    Description
    Evaluated using the EQVOD questionnaire at baseline (V2), end of diet (V3) and 3 months postoperatively Score from 36 to 180
    Time Frame
    Baseline, 4 weeks after the beggining of the diet and 3 months postoperatively
    Title
    Evolution of physical activity
    Description
    Physical activity evaluated using the Ricci et Gagnon questionnaire at baseline (V2), end of diet (V3) and 3 months postoperatively
    Time Frame
    Baseline, 4 weeks after the beggining of the diet and 3 months postoperatively
    Title
    Digestive tolerance
    Description
    Digestive tolerance evaluated using auto-questionnaire about nausea, vomiting, diarrhoea, constipation forthe interventional group, in the month of the diet
    Time Frame
    during the 4 weeks of the diet
    Title
    Compliance
    Description
    Evaluated by a food diary and the full bottles (not consumed) brought back for the intervention group, in the month of the diet
    Time Frame
    during the 4 weeks of the diet
    Title
    Degree of exposure
    Description
    Assessment of the degree of exposure of the oesogastric junction and hepatomegaly on a subjective scale of 1 to 5 by the surgeon
    Time Frame
    one day from surgery
    Title
    Operating time
    Description
    Number of hours and minuts about surgery
    Time Frame
    one day from surgery
    Title
    Length of hospital stay
    Description
    Number of days in hospital for the surgery
    Time Frame
    Four months from surgery
    Title
    Intraoperative and postoperative complications
    Description
    Delayed healing, infection and cancellation of surgery or conversion to laparotomy) up to 3 months post-operatively
    Time Frame
    Between surgery and 3 months postoperatively

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Patient eligible for bariatric surgery (according to HAS criteria) whose sleeve gastrectomy is scheduled Patient with morbid obesity (BMI ≥ 40) Age ≥ 18 years and ≤ 65 years Haemoglobinemia ≥ 12 g/dL in men and ≥ 11 g/dL in women Patient speaking and understanding French Adult having read and understood the information letter and signed the consent form Woman of childbearing age with effective / very effective contraception (Cf. CTFG) (estrogen-progestin or intrauterine device or tubal ligation) prior to surgery and a negative -HCG blood pregnancy test at inclusion, for the duration of the study Postmenopausal woman: confirmatory diagnosis (non-medically induced amenorrhoea for at least 12 months prior to the inclusion visit) Patient affiliated with, or beneficiary of a social security (health insurance) category Exclusion Criteria: Contraindication to bariatric surgery detected during the preoperative assessment Medical contraindication to a restrictive diet Type I or II insulin-requiring diabetes Severe renal insufficiency defined by a blood filtration rate < 30 mL/min Person wearing a pacemaker or any other implant with the same functions (cochlear implant, bladder battery, etc.) Person deprived of liberty by an administrative or judicial decision or person placed under judicial protection / sub-guardianship or curatorship A history of illness or psychological or sensory abnormality likely to prevent the subject from fully understanding the conditions required for participation in the protocol or to prevent him/her from giving informed consent
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Christèle DAVID
    Phone
    +33232888624
    Email
    christele.david@chu-rouen.fr
    First Name & Middle Initial & Last Name or Official Title & Degree
    Déborah LEBEDIEFF
    Phone
    +33232888265
    Email
    deborah.lebedieff@chu-rouen.fr

    12. IPD Sharing Statement

    Plan to Share IPD
    No

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