NUTritional Impact of a Hypocaloric Hyperprotein Diet Before Obesity Surgery
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorUniversity Hospital, Rouen
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
With low-calorie, high-protein diet
Dietary supplementA 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
Without low-calorie, high-protein diet
Dietary supplementA low-calorie, high-protein diet will not be prescribed to the patient for a period of 4 weeks.
Treatment groups
200 Participants
are divided into 2 treatment groupsGroup A: With dietExperimental treatment 1 intervention
Group B: Without dietOther 1 intervention
Trial outcomes
Primary outcomes
1
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
Time frame
4 weeks after the beggining of the dietSecondary outcomes
1
Weight loss
Weight difference between Visit 3 and Visit 2
Time frame
4 weeks after the beggining of the diet and 3 months postoperatively2
Reduced muscle strength
Difference in muscle strength measured with a HandGrip at Visit 2 and Visit 3)
Time frame
4 weeks after the beggining of the diet3
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
Time frame
Baseline, 4 weeks after the beggining of the diet and 3 months postoperatively4
Evolution of physical activity
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 postoperativelySponsors and contacts
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Source ClinicalTrials.gov