Tests a low-calorie, high-protein diet before obesity surgery
Tests a low-calorie, high-protein diet before surgery in adults with obesity.
Plain-language title generated from the registry record
Registry title: NUTritional Impact of a Hypocaloric Hyperprotein Diet Before Obesity Surgery
Key facts
- Where
- Dieppe, Le Havre, and Rouen, FranceSee the 3 sites
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 65 years old?
Source: NCT04942093, who can take part
Where in France
- Ch DieppeDieppe, FranceTaking people
- HPELe Havre, FranceTaking people
- CHU de RouenRouen, FranceTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- University Hospital, Rouen
- Trial code
- NCT04942093
- Record updated
- 22 September 2025
- Original description
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.Read full original descriptionShow less
NUTritional Impact of a Hypocaloric Hyperprotein Diet Before Obesity Surgery
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.
Inclusion: 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: Contraindication to bariatric surgery detected during the preoperative assessment; Person wearing a pacemaker or any other implant with the same functions (cochlear implant, bladder battery, etc.); Type I or II insulin-requiring diabetes; Severe renal insufficiency defined by a blood filtration rate < 30 mL/min; 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; Medical contraindication to a restrictive diet; Person deprived of liberty by an administrative or judicial decision or person placed under judicial protection / sub-guardianship or curatorship.