NUTritional Impact of a Hypocaloric Hyperprotein Diet Before Obesity Surgery

NCT04942093 | Recruiting

• 1 other identifier: 2019/0414/HP
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 3

Brief Summary

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

Diet, Healthy; Obesity, Visceral; Bariatric Surgery Candidate

Keywords

diet; obesity; bariatric surgery

Outcome Measures

Primary Outcomes (1)

• Poor diet tolerance

  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

  4 weeks after the beggining of the diet

Secondary Outcomes (10)

• Weight loss

  4 weeks after the beggining of the diet and 3 months postoperatively

• Reduced muscle strength

  4 weeks after the beggining of the diet

• Comparison of the quality of life between "with diet" and "without diet" with "EQVOD" questionnaire

  Baseline, 4 weeks after the beggining of the diet and 3 months postoperatively

• Evolution of physical activity

  Baseline, 4 weeks after the beggining of the diet and 3 months postoperatively

• Digestive tolerance

  during the 4 weeks of the diet

Study Arms (2)

With diet

EXPERIMENTAL

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

Dietary Supplement: With low-calorie, high-protein diet

Without diet

OTHER

A low-calorie, high-protein diet will not be prescribed to the patient for a period of 4 weeks.

Dietary Supplement: Without low-calorie, high-protein diet

Interventions

With low-calorie, high-protein diet DIETARY_SUPPLEMENT

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

With diet

Without low-calorie, high-protein diet DIETARY_SUPPLEMENT

A low-calorie, high-protein diet will not be prescribed to the patient for a period of 4 weeks.

Without diet

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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
• 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

Sponsors & Collaborators

• University Hospital, Rouen: lead

Study Sites (3)

Ch Dieppe

Dieppe, France

RECRUITING

HPE

Le Havre, France

RECRUITING

CHU de ROUEN

Rouen, 76 000, France

RECRUITING

MeSH Terms

Conditions

Obesity, Abdominal; Obesity

Interventions

Diet, High-Protein

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Diet Therapy; Nutrition Therapy; Therapeutics; Diet; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Central Study Contacts

Christèle DAVID

CONTACT

+33232888624; christele.david@chu-rouen.fr

Déborah LEBEDIEFF

CONTACT

+33232888265; deborah.lebedieff@chu-rouen.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 11, 2021
• First Posted: June 28, 2021
• Study Start: October 9, 2023
• Primary Completion (Estimated): November 20, 2026
• Study Completion (Estimated): March 20, 2027
• Last Updated: September 22, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

FR (3)