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

Qualifiers

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

Treatments tested in this trial

  • With low-calorie, high-protein diet
  • Without low-calorie, high-protein diet

Treatment groups

200 Participants
are divided into 2 treatment groups

Sponsors and collaborators