Clinical trial

NUTritional Impact of a Hypocaloric Hyperprotein Diet Before Obesity Surgery

Recruiting now · Not applicable · 1 countries · Registry ID NCT04942093

Recruiting nowNot applicableInterventional

What this study is about

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.

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age18 Years to 65 Years
SexAll
Healthy volunteersNot accepted
ConditionDiet, Healthy, Obesity, Visceral, Bariatric Surgery Candidate

Full registry 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

Treatments and study arms

With low-calorie, high-protein diet

Dietary Supplement

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

Without low-calorie, high-protein diet

Dietary Supplement

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

Primary outcomes

Poor diet tolerance4 weeks after the beggining of the diet

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

Study locations

3 locations were listed when this page was built. The first 40 are shown.

Ch Dieppe🇫🇷 Dieppe, France
Annabelle FERONContact
HPE🇫🇷 Le Havre, France
Emeline RIGAUDIEREContact
CHU de ROUEN🇫🇷 Rouen, France
Christèle DAVIDContact