With low-calorie, high-protein diet
Dietary SupplementA 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
NCT Number: NCT04942093
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.
Interested in participating?
Request Info18 year–65 year
All sexes
Interventional
Not applicable
Ch Dieppe, Dieppe, France
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.
However, there is no consensus on the benefit/risk balance of a preoperative diet and there is considerable variability in approach at national and international level.
The present clinical study involves a triad of dietician, surgeon, physician (endocrinologist/nutritionist or internist) to secure this diet. It could provide a database to help estimate the risk of undernutrition in the obese subject.
This diet, designed to facilitate the surgical procedure and potentially reduce intraoperative complications, is inexpensive, easily accessible and reproducible by other teams. This innovative management could standardise the preoperative management of patients undergoing bariatric surgery at national level. It would also improve the results of bariatric surgery both in the short term by reducing complications and in the long term by increasing weight reduction as reported in the Livhits meta-analysis. The risk of undernutrition should be reduced by this hypocaloric hyperprotein diet and consequently cancel out the increased risk of mortality, infections, delayed healing, longer hospital stay and the costs that this would entail.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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
A low-calorie, high-protein diet will not be prescribed to the patient for a period of 4 weeks.
Time frame: 4 weeks after the beggining of the diet
At least one of the following biological abnormalities at the end of the diet period:
OR
At least one of the following clinical abnormalities:
Time frame: 4 weeks after the beggining of the diet and 3 months postoperatively
Weight difference between Visit 3 and Visit 2
Time frame: 4 weeks after the beggining of the diet
Difference in muscle strength measured with a HandGrip at Visit 2 and Visit 3)
Time frame: Baseline, 4 weeks after the beggining of the diet and 3 months postoperatively
Evaluated using the EQVOD questionnaire at baseline (V2), end of diet (V3) and 3 months postoperatively Score from 36 to 180
Time frame: Baseline, 4 weeks after the beggining of the diet and 3 months postoperatively
Physical activity evaluated using the Ricci et Gagnon questionnaire at baseline (V2), end of diet (V3) and 3 months postoperatively
Time frame: during the 4 weeks of the diet
Digestive tolerance evaluated using auto-questionnaire about nausea, vomiting, diarrhoea, constipation forthe interventional group, in the month of the diet
Time frame: during the 4 weeks of the diet
Evaluated by a food diary and the full bottles (not consumed) brought back for the intervention group, in the month of the diet
Time frame: one day from surgery
Assessment of the degree of exposure of the oesogastric junction and hepatomegaly on a subjective scale of 1 to 5 by the surgeon
Time frame: one day from surgery
Number of hours and minuts about surgery
Time frame: Four months from surgery
Number of days in hospital for the surgery
Time frame: Between surgery and 3 months postoperatively
Delayed healing, infection and cancellation of surgery or conversion to laparotomy) up to 3 months post-operatively
Contact information is provided by the study sponsor or research team.
Christèle DAVID
CONTACT
Déborah LEBEDIEFF
CONTACT
University Hospital, Rouen
Other
Acronym: NUTRACOB
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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