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
About this trial
This is an interventional supportive care trial for Diet, Healthy focused on measuring diet, obesity, bariatric surgery
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
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
NCT ID
NCT04942093
First Posted
June 11, 2021
Last Updated
March 9, 2023
Sponsor
University Hospital, Rouen
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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NUTritional Impact of a Hypocaloric Hyperprotein Diet Before Obesity Surgery
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