ObesityNCT02400099
Protein-rich Diet and NAFLD in Bariatric Surgery
A study testing High-protein low calorie diet, Anthropometrical measurements and Body composition in people with Obesity and Non-alcoholic Fatty Liver Disease, run by Catholic University of the Sacred Heart at 1 site in Italy.
Trial summary
Randomized, single-blind, trial to determine whether a high-protein, low calorie diet is more effective than a control low calorie diet in improving the metabolic and histologic abnormalities in patients with Non-alcoholic Fatty Liver Disease undergoing bariatric surgery. Read more about this study
- Who is it for?
- Ages 20 to 60 years
- Conditions the study is for
- Obesity, Non-alcoholic Fatty Liver Disease
- What is being tested?
- High-protein low calorie diet, Anthropometrical measurements and Body composition
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteItaly
- Study dates
- Jun 2015to Jun 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Morbidly obese subjects with a BMI >40 kg/m2 who are eligible for bariatric surgery and have accepted to undergo RYGB
- Weight stable for at least 6 months before the study (+/- 5 kg within the previous 6 months)
- Stable medication
- Provision of informed consent
Who cannot join
- Patients not eligible for laparoscopic RYGB
- Incapacity to give a valid informed consent or unwilling to give the consent
- Pregnancy or lactating
- Type 2-diabetes mellitus
- Significant illness within the two weeks preceding surgery, as judged by the physician.
- Obvious infection (bacteria, virus etc)
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- Major cardiovascular disease
- Major gastrointestinal, respiratory, or any hormonal disorders
- History of drug addiction and/or alcohol use
- Suspected or confirmed poor compliance
- Alcohol consumption of > 20 g per day in the case of women and > 30 g per day in the case of men for at least 3 consecutive months during the previous 5 years
- Presence of hepatitis C or frank cirrhosis.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Protein-rich Diet and Non-Alcoholic Fatty Liver Disease in Bariatric Surgery
Randomized, single-blind, trial to determine whether a high-protein, low calorie diet is more effective than a control low calorie diet in improving the metabolic and histologic abnormalities in patients with Non-alcoholic Fatty Liver Disease undergoing bariatric surgery.
- Conditions
- Obesity, Non-alcoholic Fatty Liver Disease
- Being tested
- High-protein low calorie diet, Control low calorie diet, Anthropometrical measurements, Body composition, 8-h metabolic profile
- Medical subject headings
- Obesity, Non-alcoholic Fatty Liver Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High-protein low calorie dietDietary supplement
Control low calorie dietDietary supplement
Anthropometrical measurementsOther
Body compositionOther
8-h metabolic profileOther
Liver biopsyOther
| Study group | Role | What they receive |
|---|---|---|
| High-protein low calorie diet (HPLC) | Active comparator | 900 Kcal; Protein 90 g (39%); CHO 75 g (30%); Lipid 32 g (31%) Receives: Dietary Supplement: High-protein low calorie diet; Other: Anthropometrical measurements; Other: Body composition; Other: 8-h metabolic profile; Other: Liver biopsy |
| Control low calorie diet (CLC) | Placebo comparator | 900 Kcal; Protein. 50 g (22%); CHO 119 g (48%); Lipid 31 g (30%) Receives: Dietary Supplement: Control low calorie diet; Other: Anthropometrical measurements; Other: Body composition; Other: 8-h metabolic profile; Other: Liver biopsy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Liver fat content assessment
Measured: 1 year
Secondary outcomes (2)
Insulin sensitivity assessment
Measured: 1 year
fat free mass assessment
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2015 (estimated)
- Study startJun 2015
- Primary completionJun 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Catholic University of the Sacred Heart
- Sponsor type
- University, hospital or other
- Collaborators
- Federico II University
- Responsible party
- Principal investigator, Geltrude Mingrone, Catholic University of the Sacred Heart
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02400099
- Sponsor's protocol ID
- UCSC-2015
- Status last verified
- Mar 2015
- First submitted
- 23 Mar 2015
- Last updated
- 26 Mar 2015
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Protein-rich Diet and Non-Alcoholic Fatty Liver Disease in Bariatric Surgery
- ClinicalTrials.gov ID
- NCT02400099
- Acronym / sponsor ID
- UCSC-2015
- Conditions
- Obesity, Non-alcoholic Fatty Liver Disease
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Catholic University of the Sacred HeartUniversity, hospital or other
- Collaborators
- Federico II University
- Study start
- Jun 2015
- Primary completion
- Jun 2016 (estimated)
- First posted
- 26 Mar 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Randomized, single-blind, trial to determine whether a high-protein, low calorie diet is more effective than a control low calorie diet in improving the metabolic and histologic abnormalities in patients with Non-alcoholic Fatty Liver Disease undergoing bariatric surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| High-protein low calorie diet (HPLC) | Active comparator | Dietary Supplement: High-protein low calorie diet, Other: Anthropometrical measurements, Other: Body composition, Other: 8-h metabolic profile, Other: Liver biopsy900 Kcal; Protein 90 g (39%); CHO 75 g (30%); Lipid 32 g (31%) |
| Control low calorie diet (CLC) | Placebo comparator | Dietary Supplement: Control low calorie diet, Other: Anthropometrical measurements, Other: Body composition, Other: 8-h metabolic profile, Other: Liver biopsy900 Kcal; Protein. 50 g (22%); CHO 119 g (48%); Lipid 31 g (30%) |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Morbidly obese subjects with a BMI >40 kg/m2 who are eligible for bariatric surgery and have accepted to undergo RYGB
- Weight stable for at least 6 months before the study (+/- 5 kg within the previous 6 months)
- Stable medication
- Provision of informed consent
Key exclusion criteria (12 listed)
- Patients not eligible for laparoscopic RYGB
- Incapacity to give a valid informed consent or unwilling to give the consent
- Pregnancy or lactating
- Type 2-diabetes mellitus
- Significant illness within the two weeks preceding surgery, as judged by the physician.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| High-protein low calorie diet | Dietary supplement | High-protein low calorie diet (HPLC) |
| Control low calorie diet | Dietary supplement | Control low calorie diet (CLC) |
| Anthropometrical measurements | Other | Control low calorie diet (CLC), High-protein low calorie diet (HPLC) |
| Body composition | Other | Control low calorie diet (CLC), High-protein low calorie diet (HPLC) |
| 8-h metabolic profile | Other | Control low calorie diet (CLC), High-protein low calorie diet (HPLC) |
| Liver biopsy | Other | Control low calorie diet (CLC), High-protein low calorie diet (HPLC) |
Primary outcome
Liver fat content assessment
Time frame: 1 year
2 secondary outcomes
Insulin sensitivity assessment
Time frame: 1 year
fat free mass assessment
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Mar 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High-protein low calorie diet, Anthropometrical measurements and Body composition in people with Obesity and Non-alcoholic Fatty Liver Disease, run by Catholic University of the Sacred Heart at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Geltrude Mingrone, Professor (0630154395 ext. 0039, gmingrone@rm.unicatt.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Liver fat content assessment (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Mar 2015.