NUTritional Impact of a Hypocaloric Hyperprotein Diet Before Obesity Surgery

Recruiting now · Not applicable

Conditions studied: Diet, Healthy, Obesity, Visceral, Bariatric Surgery Candidate

In brief

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.

Key facts

Study ID: NCT04942093
Run by: University Hospital, Rouen
People needed: 200
Starts: 2023-10-09
Expected to finish: 2027-03-20
Last updated by the study team: 2025-09-22

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

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

Where it is running

Ch Dieppe — Dieppe, France (enrolling)
HPE — Le Havre, France (enrolling)
CHU de ROUEN — Rouen, France (enrolling)

Full record on ClinicalTrials.gov

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