ObesityNCT03029572
Micro-nutritional Status and Gut Microbiota in Morbidly Obese Patients Before and After Gastric Bypass
A study testing Diet supplementation and Bariatric surgery in people with Obesity and Bariatric Surgery Candidate, run by University Hospital, Geneva at 1 site in Switzerland.
Trial summary
An intervention study design in 90 obese patients will be used. Nutritional, metabolic and psychological status as well as gut microbiota will be evaluated before gastric bypass and 6 months post surgery. Read more about this study
- Who is it for?
- Ages 20 to 60 years
- Conditions the study is for
- Obesity, Bariatric Surgery Candidate
- What is being tested?
- Diet supplementation and Bariatric surgery
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteSwitzerland
- Study dates
- Feb 2009to Dec 2012
- 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
- Obesity BMI>40 kg/m2
Who cannot join
- Antidepressant treatment
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Micro-nutritional Status and Gut Microbiota in Morbidly Obese Patients Before and After Gastric Bypass With and Without Micro-nutritional Supplementation
An intervention study design in 90 obese patients will be used. Nutritional, metabolic and psychological status as well as gut microbiota will be evaluated before gastric bypass and 6 months post surgery. During this period of 6 months, all patients will receive a specific diet according to recommendation with regard to bariatric surgery.
Subjects will be than randomized in 2 sub-groups:
- patients receiving a standard healthy diet without micro-nutriments' supplementation; B. patients receiving a healthy diet and probiotics, minerals, aminoacids, omega-3 acids vitamin and mineral supplementation
Read the detailed description
The primary aim of the study is to analyse the micro-nutritional status in morbidly obese patients before and 6 months after bariatric surgery (Roux-en-Y gastric bypass, RYGB). The secondary outcome will be the impact of 6 months probiotics, minerals, aminoacids, omega-3 acids and vitamin supplementation on microbiota, metabolic and psychological parameters 12 months post-RYGB.
An intervention study in 90 obese patients (BMI>40 kg/m2) will be used. Nutritional, metabolic and psychological status as well as gut microbiota will be evaluated before gastric bypass and 6 months post RYGB. During this period of 6 months, all patients will receive a specific diet according to recommendation with regard to RYGB.
Subjects will be than randomized in 2 sub-groups:
- patients receiving a standard healthy diet without micro-nutriments' supplementation; B. patients receiving a healthy diet and probiotics, minerals, aminoacids, omega-3 acids vitamin and mineral supplementation Healthy diet will be defined as follow: 9-15% of proteins, 50-55% of carbohydrates and 30-35% lipids (25% saturated fat, 50% mono-unsaturated fat and 25% poly-unsaturated fat).
The following parameters will be analysed before RYGB and 6 months and 12 months post RYGB, respectively:
- Nutritional status with oxidative stress parameters (Vitamins A and E, Selenium, Zinc, Copper, Glutathione peroxidise, Superoxide dismutase and Iron)
- Metabolic parameters (Total cholesterol, LDL-cholesterol, HDL-cholesterol, Triglycerides, fasting glucose and insulin, CRP)
- Fatty acids (linoleic acid, alpha-linoleic acid (ALA), eicosapentaenoic acid (EPA), and docosahexaenoic acid (DHA)
- Gut microbiota
- Psychological status (anxiety, depression and quality of life as evaluated by validated questionnaires).
- Conditions
- Obesity, Bariatric Surgery Candidate
- Being tested
- Diet supplementation, Bariatric surgery
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diet supplementationDrug
Micronutriment supplementation therapy
Bariatric surgeryProcedure or surgery
Roux-en-Y gastric bypass provided in both arms.
| Study group | Role | What they receive |
|---|---|---|
| Standard diet | Active comparator | Standard healthy diet after RYGB surgery Receives: Procedure: Bariatric surgery |
| Micro-nutriments' supplementation | Experimental | Healthy diet and probiotics, minerals, aminoacids, omega-3 acids vitamin and mineral supplementation after RYGB surgery Receives: Drug: Diet supplementation; Procedure: Bariatric surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Vitamins A levels
Measured: Change from Baseline at 6-months and 12-months post-RYGB
Vitamin E levels
Measured: Change from Baseline at 6-months and 12-months post-RYGB
Selenium levels
Measured: Change from Baseline at 6-months and 12-months post-RYGB
Zinc levels
Measured: Change from Baseline at 6-months and 12-months post-RYGB
Copper levels
Measured: Change from Baseline at 6-months and 12-months post-RYGB
Glutathione peroxidise
Measured: Change from Baseline at 6-months and 12-months post-RYGB
Superoxide dismutase
Measured: Change from Baseline at 6-months and 12-months post-RYGB
Iron levels
Measured: Change from Baseline at 6-months and 12-months post-RYGB
Secondary outcomes (15)
Total cholesterol
Measured: 6-months and 12-months post-RYGB
LDL-cholesterol
Measured: 6-months and 12-months post-RYGB
HDL-cholesterol
Measured: 6-months and 12-months post-RYGB
Triglycerides
Measured: 6-months and 12-months post-RYGB
Fasting glucose
Measured: 6-months and 12-months post-RYGB
Fasting insulin
Measured: 6-months and 12-months post-RYGB
C-Reactive Protein
Measured: 6-months and 12-months post-RYGB
Linoleic acid
Measured: 6-months and 12-months post-RYGB
Alpha-linoleic acid (ALA)
Measured: 6-months and 12-months post-RYGB
Eicosapentaenoic acid (EPA)
Measured: 6-months and 12-months post-RYGB
Docosahexaenoic acid (DHA)
Measured: 6-months and 12-months post-RYGB
Gut microbiota modifications (sequencing the V4 region of 16S rDNA)
Measured: 6-months and 12-months post-RYGB
Anxiety (questionnaire HAD)
Measured: 6-months and 12-months post-RYGB
Depression (questionnaire HAD)
Measured: 6-months and 12-months post-RYGB
Quality of life (questionnaire IWQOL)
Measured: 6-months and 12-months post-RYGB
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jan 2017 (estimated)
- Study startFeb 2009
- Primary completionDec 2011
- Study completionDec 2012
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.
- More trials run by University Hospital, GenevaThe sponsor's other registered studies.
- 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
- Participant
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Geneva
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zoltan Pataky, University Hospital, Geneva
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03029572
- Sponsor's protocol ID
- 08-005
- Status last verified
- Jan 2017
- First submitted
- 14 Jan 2017
- Last updated
- 24 Jan 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Micro-nutritional Status and Gut Microbiota in Morbidly Obese Patients Before and After Gastric Bypass With and Without Micro-nutritional Supplementation
- ClinicalTrials.gov ID
- NCT03029572
- Acronym / sponsor ID
- 08-005
- Conditions
- Obesity, Bariatric Surgery Candidate
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- University Hospital, GenevaUniversity, hospital or other
- Study start
- Feb 2009
- Primary completion
- Dec 2011 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 24 Jan 2017 (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.
An intervention study design in 90 obese patients will be used. Nutritional, metabolic and psychological status as well as gut microbiota will be evaluated before gastric bypass and 6 months post surgery. During this period of 6 months, all patients will receive a specific diet according to recommendation with regard to bariatric surgery.
Subjects will be than randomized in 2 sub-groups:
- patients receiving a standard healthy diet without micro-nutriments' supplementation; B. patients receiving a healthy diet and probiotics, minerals, aminoacids, omega-3 acids vitamin and mineral supplementation
Detailed description
The primary aim of the study is to analyse the micro-nutritional status in morbidly obese patients before and 6 months after bariatric surgery (Roux-en-Y gastric bypass, RYGB). The secondary outcome will be the impact of 6 months probiotics, minerals, aminoacids, omega-3 acids and vitamin supplementation on microbiota, metabolic and psychological parameters 12 months post-RYGB.
An intervention study in 90 obese patients (BMI>40 kg/m2) will be used. Nutritional, metabolic and psychological status as well as gut microbiota will be evaluated before gastric bypass and 6 months post RYGB. During this period of 6 months, all patients will receive a specific diet according to recommendation with regard to RYGB.
Subjects will be than randomized in 2 sub-groups:
- patients receiving a standard healthy diet without micro-nutriments' supplementation; B. patients receiving a healthy diet and probiotics, minerals, aminoacids, omega-3 acids vitamin and mineral supplementation Healthy diet will be defined as follow: 9-15% of proteins, 50-55% of carbohydrates and 30-35% lipids (25% saturated fat, 50% mono-unsaturated fat and 25% poly-unsaturated fat).
The following parameters will be analysed before RYGB and 6 months and 12 months post RYGB, respectively:
- Nutritional status with oxidative stress parameters (Vitamins A and E, Selenium, Zinc, Copper, Glutathione peroxidise, Superoxide dismutase and Iron)
- Metabolic parameters (Total cholesterol, LDL-cholesterol, HDL-cholesterol, Triglycerides, fasting glucose and insulin, CRP)
- Fatty acids (linoleic acid, alpha-linoleic acid (ALA), eicosapentaenoic acid (EPA), and docosahexaenoic acid (DHA)
- Gut microbiota
- Psychological status (anxiety, depression and quality of life as evaluated by validated questionnaires).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard diet | Active comparator | Procedure: Bariatric surgeryStandard healthy diet after RYGB surgery |
| Micro-nutriments' supplementation | Experimental | Drug: Diet supplementation, Procedure: Bariatric surgeryHealthy diet and probiotics, minerals, aminoacids, omega-3 acids vitamin and mineral supplementation after RYGB surgery |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Obesity BMI>40 kg/m2
Key exclusion criteria (1 listed)
- Antidepressant treatment
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 |
|---|---|---|
| Diet supplementationMicronutriment supplementation therapy | Drug | Micro-nutriments' supplementation |
| Bariatric surgeryRoux-en-Y gastric bypass provided in both arms. | Procedure or surgery | Micro-nutriments' supplementation, Standard diet |
Primary outcome
Vitamins A levels
Time frame: Change from Baseline at 6-months and 12-months post-RYGB
Vitamin E levels
Time frame: Change from Baseline at 6-months and 12-months post-RYGB
Selenium levels
Time frame: Change from Baseline at 6-months and 12-months post-RYGB
Zinc levels
Time frame: Change from Baseline at 6-months and 12-months post-RYGB
Copper levels
Time frame: Change from Baseline at 6-months and 12-months post-RYGB
Glutathione peroxidise
Time frame: Change from Baseline at 6-months and 12-months post-RYGB
Superoxide dismutase
Time frame: Change from Baseline at 6-months and 12-months post-RYGB
Iron levels
Time frame: Change from Baseline at 6-months and 12-months post-RYGB
15 secondary outcomes
Total cholesterol
Time frame: 6-months and 12-months post-RYGB
LDL-cholesterol
Time frame: 6-months and 12-months post-RYGB
HDL-cholesterol
Time frame: 6-months and 12-months post-RYGB
Triglycerides
Time frame: 6-months and 12-months post-RYGB
Fasting glucose
Time frame: 6-months and 12-months post-RYGB
Fasting insulin
Time frame: 6-months and 12-months post-RYGB
C-Reactive Protein
Time frame: 6-months and 12-months post-RYGB
Linoleic acid
Time frame: 6-months and 12-months post-RYGB
Alpha-linoleic acid (ALA)
Time frame: 6-months and 12-months post-RYGB
Eicosapentaenoic acid (EPA)
Time frame: 6-months and 12-months post-RYGB
Docosahexaenoic acid (DHA)
Time frame: 6-months and 12-months post-RYGB
Gut microbiota modifications (sequencing the V4 region of 16S rDNA)
Time frame: 6-months and 12-months post-RYGB
Anxiety (questionnaire HAD)
Time frame: 6-months and 12-months post-RYGB
Depression (questionnaire HAD)
Time frame: 6-months and 12-months post-RYGB
Quality of life (questionnaire IWQOL)
Time frame: 6-months and 12-months post-RYGB
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jan 2017.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Diet supplementation and Bariatric surgery in people with Obesity and Bariatric Surgery Candidate, run by University Hospital, Geneva at 1 site in Switzerland.
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 1 inclusion and 1 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: finished, as of the sponsor's last update on 24 Jan 2017. 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 Switzerland. 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. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Vitamins A levels (time frame: Change from Baseline at 6-months and 12-months post-RYGB). The study lists 8 primary outcomes in all. 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 24 Jan 2017.