Last reviewed · How we verify
NCT04942093: NUTRACOB
NUTritional Impact of a Hypocaloric Hyperprotein Diet Before Obesity Surgery
NA trial testing With low-calorie, high-protein diet in Diet, Healthy in 200 participants. Currently enrolling.
20 November 2026
Quick facts
| Lead sponsor | University Hospital, Rouen |
|---|---|
| Phase | NA |
| Status | Recruiting now |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | supportive care |
| Enrollment | 200 |
| Start date | 9 October 2023 |
| Primary completion | 20 November 2026 |
| Estimated completion | 20 March 2027 |
| Sites | 3 locations across France |
Drugs / interventions tested
- With low-calorie, high-protein diet
- Without low-calorie, high-protein diet
Conditions studied
- Diet, Healthy — all drugs for Diet, Healthy →
- Obesity, Visceral — all drugs for Obesity, Visceral →
- Bariatric Surgery Candidate — all drugs for Bariatric Surgery Candidate →
Sponsor
University Hospital, Rouen
Who can join
Adults 18 to 65, any sex, with Diet, Healthy or Obesity, Visceral. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own 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. 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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT04942093
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Other University Hospital, Rouen trials
Trials by the same sponsor.
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT04942093 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by University Hospital, Rouen
- Last refreshed: 22 September 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04942093.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing