Clinical trial
NUTritional Impact of a Hypocaloric Hyperprotein Diet Before Obesity Surgery
Recruiting now · Not applicable · 1 countries · Registry ID NCT04942093
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.
Basic eligibility
Full registry criteria
Treatments and study arms
With low-calorie, high-protein diet
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
A low-calorie, high-protein diet will not be prescribed to the patient for a period of 4 weeks.
Primary outcomes
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