ObesityNCT03147456
Protein Supplementation Impact On Body Muscle Mass And Fat Mass In Qataris Post Bariatric Surgery, Randomized Controlled Trials (Rct)
A study testing (Cubitan Protein, Nutricia, Netherlands). and (preOp, Nutricia, Netherlands). in people with Obesity, run by Hamad Medical Corporation at 1 site in Qatar.
Trial summary
One of the most common post-operative deficiencies or complications of bariatric surgery is protein malnutrition. It may lead to many predicaments such as malnutrition, vitamin, micro- and macronutrient deficiencies that can lead to deleterious consequences. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Obesity
- What is being tested?
- (Cubitan Protein, Nutricia, Netherlands). and (preOp, Nutricia, Netherlands).
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteQatar
- Study dates
- 8 Mar 2017to 1 Aug 2017
- 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 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Study participants must have the following criteria in order to participate in the trial:
- Qatari males or females.
- Aged between 18 and 60 year
- Based at the bariatric surgery list of HMC with their follow up scheduled be at HMC.
Who cannot join
- Patients will be excluded from participating in the trial if they have the following criteria:
- Any Renal or liver disease because that will affect protein or albumin level in body.
- Past history of bariatric surgery
- Patients will be further excluded after starting the trial if they fall into the following categories:
- Subjects who did not take at least 80% of their intervention product amount per day, or
- Subjects who did not comply with the treatment (or placebo) for more than 3 days per week.
- Also, patients who refuse to participate \& patients with baseline tests showing they are in need for protein supplements will be excluded from the study and given the needed protein supplements per the standard care.
Trial locations and contacts
1 site in 1 country.
Fahad Hanna contact
Qatar1 site, 1 recruiting
- Recruiting
sahar Dahawi Alshamari
Doha, 00974
fahad hanna, 70561906
About this study
Official title: Protein Supplementation Impact On Body Muscle Mass And Fat Mass In Qataris Post Bariatric Surgery, Randomized Controlled Trials (Rcts)
One of the most common post-operative deficiencies or complications of bariatric surgery is protein malnutrition. It may lead to many predicaments such as malnutrition, vitamin, micro- and macronutrient deficiencies that can lead to deleterious consequences. A protein-rich diet make a person feel satiety and thereby the consumption will be low in overall energy intake. The objectives of our study are. The aim of this study is to assess the effect of protein supplementation on changes in health parameters such as fat mass, muscle mass, weigh change, protein (total and albumin), Vit B12, Zinc and Magnesium, in Qatari patients post bariatric surgery. Our participants are Qatari aged 18-45 years males and females recruited from the bariatric surgery centers of 2 major HMC hospitals (HGH hospital) and will be randomized to receive either the protein supplement (treatment group) or a dietary advice (control group). All participants will be equally followed and monitored for 3 months and data on the above parameters will be collected, together with other population characteristics, at Baseline, 1 month and 3 month. Data will then be analyzed using the most up-to-date SPSS statistical package to assess the effect of protein supplementation on the parameters of interest. Statistical measures will be carefully chosen to properly assess the difference in the treatment (protein supplementation) effect compared with the control (Dietary advice). Investigators hypothesize that Patients receiving protein supplement (intervention group) Compared with patient not on protein supplement (placebo group) will maintain weight loss and other essential health parameters.
- Conditions
- Obesity
- Being tested
- (Cubitan Protein, Nutricia, Netherlands)., (preOp, Nutricia, Netherlands).
- Keywords
- bariatric, obesity, protein supplements
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
(Cubitan Protein, Nutricia, Netherlands).Dietary supplement
Supplement contains (per 200 ml can) 20 g of protein, 250Kacl plus different micronutrient and macronutrient.
(preOp, Nutricia, Netherlands).Dietary supplement
contains per can (200 ml), 0g protein, fat free, 100 kcal and enriched with electrolytes
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | Patients will receive nutritional counseling by a bariatric dietitian in a routine round, aiming that they will know the post-surgery diet stages and to not develop any nutritional deficiencies.Before discharge from the hospital, patients will receive supplement and will be advised by the dietitian regarding its use (one can per day, over 3-5 intervals). Supplement contains (per 200 ml can) 20 g of protein, 250Kacl plus different micronutrient and macronutrient (Cubitan Protein, Nutricia, Netherlands). Receives: Dietary Supplement: (Cubitan Protein, Nutricia, Netherlands). |
| Control group | Placebo comparator | Patients will receive nutritional counseling by a bariatric dietitian in a routine round, aiming that they will know the post-surgery diet stages and to not develop any nutritional deficiencies. Before discharge from the hospital, patients will receive supplement and will be advised by the dietitian regarding its use (one can per day over 3-5 intervals).Following hospital discharge, Control patients will receive supplement contains per can (200 ml), 0g protein, fat free, 100 kcal and enriched with electrolytes (preOp, Nutricia, Netherlands). Receives: Dietary Supplement: (preOp, Nutricia, Netherlands). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measurement of changes in Body Weight
Measurement of changes in Body Weight
Measured: 3 months
Measurement of changes in Muscle mass.
Measurement of changes in Muscle mass.
Measured: 3 months
Measurement of changes in Fat mass.
Measurement of changes in Muscle mass.
Measured: 3 months
Secondary outcomes (4)
To assess the measurement on Protein
To assess the measurement on Protein
Measured: 3 months
To assess the measurement on Vitamin B12
To assess the measurement on Vitamin B12
Measured: 3 months
To assess the measurement on Magnesium
To assess the measurement on Magnesium
Measured: 3 months
To assess the Zinc level measurement
To assess the Zinc level measurement
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 May 2017
- Study start8 Mar 2017
- Primary completion1 Aug 2017 (estimated)
- Study completion1 Aug 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by Hamad Medical CorporationThe 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hamad Medical Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03147456
- Sponsor's protocol ID
- 16433
- Status last verified
- Mar 2017
- First submitted
- 18 Apr 2017
- Last updated
- 10 May 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Al-Shamari SD, ElSherif MA, Hamid W, Hanna F. The effect of protein supplementation on body muscle mass and fat mass in post-bariatric surgery: a randomized controlled trial (RCT) study protocol. Arch Public Health. 2018 Jan 22;76:7. doi: 10.1186/s13690-017-0252-2. eCollection 2018.
PubMed 29423219
Study at a glance
From the registry record, last updated by the sponsor on 10 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Protein Supplementation Impact On Body Muscle Mass And Fat Mass In Qataris Post Bariatric Surgery, Randomized Controlled Trials (Rcts)
- ClinicalTrials.gov ID
- NCT03147456
- Acronym / sponsor ID
- 16433
- Conditions
- Obesity
- Keywords
- bariatric, obesity, protein supplements
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Hamad Medical CorporationIndustry (pharma, biotech, devices)
- Study start
- 8 Mar 2017 (actual)
- Primary completion
- 1 Aug 2017 (estimated)
- Study completion
- 1 Aug 2017 (estimated)
- First posted
- 10 May 2017 (actual)
- 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.
One of the most common post-operative deficiencies or complications of bariatric surgery is protein malnutrition. It may lead to many predicaments such as malnutrition, vitamin, micro- and macronutrient deficiencies that can lead to deleterious consequences. A protein-rich diet make a person feel satiety and thereby the consumption will be low in overall energy intake. The objectives of our study are. The aim of this study is to assess the effect of protein supplementation on changes in health parameters such as fat mass, muscle mass, weigh change, protein (total and albumin), Vit B12, Zinc and Magnesium, in Qatari patients post bariatric surgery. Our participants are Qatari aged 18-45 years males and females recruited from the bariatric surgery centers of 2 major HMC hospitals (HGH hospital) and will be randomized to receive either the protein supplement (treatment group) or a dietary advice (control group). All participants will be equally followed and monitored for 3 months and data on the above parameters will be collected, together with other population characteristics, at Baseline, 1 month and 3 month. Data will then be analyzed using the most up-to-date SPSS statistical package to assess the effect of protein supplementation on the parameters of interest. Statistical measures will be carefully chosen to properly assess the difference in the treatment (protein supplementation) effect compared with the control (Dietary advice). Investigators hypothesize that Patients receiving protein supplement (intervention group) Compared with patient not on protein supplement (placebo group) will maintain weight loss and other essential health parameters.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Dietary Supplement: (Cubitan Protein, Nutricia, Netherlands).Patients will receive nutritional counseling by a bariatric dietitian in a routine round, aiming that they will know the post-surgery diet stages and to not develop any nutritional deficiencies.Before discharge from the hospital, patients will receive supplement and will be advised by the dietitian regarding its use (one can per day, over 3-5 intervals). Supplement contains (per 200 ml can) 20 g of protein, 250Kacl plus different micronutrient and macronutrient (Cubitan Protein, Nutricia, Netherlands). |
| Control group | Placebo comparator | Dietary Supplement: (preOp, Nutricia, Netherlands).Patients will receive nutritional counseling by a bariatric dietitian in a routine round, aiming that they will know the post-surgery diet stages and to not develop any nutritional deficiencies. Before discharge from the hospital, patients will receive supplement and will be advised by the dietitian regarding its use (one can per day over 3-5 intervals).Following hospital discharge, Control patients will receive supplement contains per can (200 ml), 0g protein, fat free, 100 kcal and enriched with electrolytes (preOp, Nutricia, Netherlands). |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Qatari males or females.
- Aged between 18 and 60 year
- Based at the bariatric surgery list of HMC with their follow up scheduled be at HMC.
Key exclusion criteria (7 listed)
- Patients will be excluded from participating in the trial if they have the following criteria:
- Any Renal or liver disease because that will affect protein or albumin level in body.
- Past history of bariatric surgery
- Patients will be further excluded after starting the trial if they fall into the following categories:
- Also, patients who refuse to participate \& patients with baseline tests showing they are in need for protein supplements will be excluded from the study and given the needed protein supplements per the standard care.
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 |
|---|---|---|
| (Cubitan Protein, Nutricia, Netherlands).Supplement contains (per 200 ml can) 20 g of protein, 250Kacl plus different micronutrient and macronutrient. | Dietary supplement | Intervention group |
| (preOp, Nutricia, Netherlands).contains per can (200 ml), 0g protein, fat free, 100 kcal and enriched with electrolytes | Dietary supplement | Control group |
Primary outcome
Measurement of changes in Body Weight
Time frame: 3 months
Measurement of changes in Body Weight
Measurement of changes in Muscle mass.
Time frame: 3 months
Measurement of changes in Muscle mass.
Measurement of changes in Fat mass.
Time frame: 3 months
Measurement of changes in Muscle mass.
4 secondary outcomes
To assess the measurement on Protein
Time frame: 3 months
To assess the measurement on Vitamin B12
Time frame: 3 months
To assess the measurement on Magnesium
Time frame: 3 months
To assess the Zinc level measurement
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 May 2017.
- Derived from this study: PubMed 29423219Al-Shamari SD, ElSherif MA, Hamid W, Hanna F. The effect of protein supplementation on body muscle mass and fat mass in post-bariatric surgery: a randomized controlled trial (RCT) study protocol. Arch Public Health. 2018 Jan 22;76:7. doi: 10.1186/s13690-017-0252-2. eCollection 2018.
- 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.
Fahad Hanna contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing (Cubitan Protein, Nutricia, Netherlands). and (preOp, Nutricia, Netherlands). in people with Obesity, run by Hamad Medical Corporation at 1 site in Qatar.
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 7 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 10 May 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 Qatar. 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 Sahar Dahawi Alshamari (66655122, Salshamari1@hamad.qa), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measurement of changes in Body Weight (time frame: 3 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03147456, which also lists 1 linked publication.
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 10 May 2017.