Actively Recruiting

Phase Not Applicable
Age: 18Years - 65Years
All Genders
NCT04942093

NUTritional Impact of a Hypocaloric Hyperprotein Diet Before Obesity Surgery

Led by University Hospital, Rouen · Updated on 2025-09-22

200

Participants Needed

3

Research Sites

179 weeks

Total Duration

On this page

AI-Summary

What this Trial 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.

CONDITIONS

Official Title

NUTritional Impact of a Hypocaloric Hyperprotein Diet Before Obesity Surgery

Who Can Participate

Age: 18Years - 65Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patient eligible for bariatric surgery with scheduled sleeve gastrectomy
  • Morbid obesity with BMI greater than or equal to 40
  • Age between 18 and 65 years
  • Hemoglobinemia at least 12 g/dL for men and at least 11 g/dL for women
  • Ability to speak and understand French
  • Adult who has read, understood, and signed the consent form
  • Women of childbearing age using effective contraception and negative pregnancy test at inclusion
  • Postmenopausal women with confirmed diagnosis of amenorrhea for at least 12 months
  • Affiliated with or beneficiary of social security health insurance
Not Eligible

You will not qualify if you...

  • Contraindications to bariatric surgery found during preoperative assessment
  • Medical contraindications to a restrictive diet
  • Type I or II diabetes requiring insulin
  • Severe kidney failure with filtration rate below 30 mL/min
  • Having a pacemaker or similar implant (e.g., cochlear implant, bladder battery)
  • Being deprived of liberty by legal decision or under judicial protection, guardianship, or curatorship
  • History of illness or psychological or sensory issues preventing understanding of the study or informed consent

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 3 locations

1

Ch Dieppe

Dieppe, France

Actively Recruiting

2

HPE

Le Havre, France

Actively Recruiting

3

CHU de ROUEN

Rouen, France, 76 000

Actively Recruiting

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Research Team

C

Christèle DAVID

CONTACT

D

Déborah LEBEDIEFF

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

SUPPORTIVE_CARE

Number of Arms

2

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