Bariatric SurgeryNCT04510389
Impact of Whey Protein Supplementation on Body Weight and Metabolic Parameters of Bariatric Patients
A study testing Maltodextrin and Whey in people with Bariatric Surgery and Sarcopenia, run by Federal University of Minas Gerais at 1 site in Brazil.
Trial summary
Obesity is a metabolic disorder, characterized by an increase in the body's fat mass, which will reflect an increase in total body weight. In Brazil, overweight accounts for 53.8% of the population, and of these 18.9% are obese. Read more about this study
- Who is it for?
- Ages 20 to 60 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Bariatric Surgery, Sarcopenia
- What is being tested?
- Maltodextrin and Whey
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteBrazil
- Study dates
- 1 Mar 2019to 14 Feb 2023
- 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
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Patients of both sexes over 20 years of age
- Patients with regular follow-up in the postoperative period.
Who cannot join
- Patients with debilitating chronic diseases
- Severe vomiting
- Submitted to other surgical procedures before 18 months of surgery
- Patient with prostheses
- Use or introduction of drugs immunosuppressants or affecting metabolism
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Laboratório de Aterosclerose e Bioquimica Nutricional
Belo Horizonte, Minas Gerais, 30161-970
About this study
Official title: Impact of Whey Protein Supplementation on Body Composition, Energy Expenditure and Biochemical Parameters of Patients Submitted to Bariatric Surgery
Obesity is a metabolic disorder, characterized by an increase in the body's fat mass, which will reflect an increase in total body weight. In Brazil, overweight accounts for 53.8% of the population, and of these 18.9% are obese. Surgical treatment is currently the most successful method for weight loss in patients with Grade III obesity and reduced associated morbidities. The general objective is to evaluate genetic, inflammatory, and dietary factors that would influence weight loss and the appearance of protein deficiency or sarcopenia in patients undergoing bariatric surgery and to evaluate the effects of protein supplementation for 8 weeks after the 18th postoperative month in the parameters evaluated. The study has a randomized, placebo-controlled, double-masked model. The patients will be selected in two bariatric surgery services accredited by the Brazilian Health Unic System (SUS) in the city of Belo Horizonte, Brazil.
The project has already been approved by the Brazilian Ethics committee CONEP/UFMG by nº. 75415317.8.0000.5149. Patients of both sexes over 20 years of age will be included, attending the hospitals of the project with regular follow-up in the postoperative period. Data on anthropometry, body composition, muscle strength, energy expenditure, and inflammatory profile will be collected. The data will be correlated with the evaluation of the presence of genetic polymorphisms.
Read the detailed description
Specific objectives:
It is also objective to evaluate:
- To observe the food consumption between 18 and 24 months of surgery with respect to protein and caloric intake;
- Evolution of weight loss, lean mass, fat mass and metabolic rate before and after supplementation with WP or placebo;
- Changes in protein status (assessed by muscle strength and serum levels of total protein, albumin, prealbumin, ferritin, hemoglobin) before and after supplementation with WP or placebo
- The inflammatory blood profile (assessed by cytokine levels and before and after supplementation with WP or placebo).
- The influence of the rS9939609 polymorphism of the FTO gene on the nutritional status, biochemical and inflammatory parameters in the postoperative (after 18 months) of surgery;
- Conditions
- Bariatric Surgery, Sarcopenia
- Being tested
- Maltodextrin, Whey
- Keywords
- obesity, sarcopenia, bariatric surgery, protein
- Medical subject headings
- Sarcopenia, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MaltodextrinDietary supplement
Bariatric patients with or without sarcopenia receiving maltodextrin
WheyDietary supplement
Bariatric patients with or without sarcopenia receiving whey protein
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | volunteers will receive 28 sachets containing 30g of maltodextrin to be consumed daily for 4 weeks. After that they will return to the 4-week visit and assessment when they will receive 28 sachets for the next 28 days when will return for the final vist and assessment. Receives: Dietary Supplement: Maltodextrin |
| Whey | Experimental | volunteers will receive 28 sachets containing 30g of whey protein to be consumed daily for 4 weeks. After that they will return to the 4-week visit and assessment when they will receive 28 sachets for the next 28 days when will return for the final vist and assessment. Receives: Dietary Supplement: Whey |
What is being measured
The primary outcome is the main question the study is designed to answer.
Body Weight variation
measured in scale presented in kg
Measured: 8th week
Muscle mass
measure by portable US
Measured: 8th week
Secondary outcomes (6)
Body Weight variation
measured in scale presented in kg
Measured: 4th week
Resting metabolic rate
measured by indirect calorimetry in kcal/kg/day
Measured: 4th week
Muscle mass
measure by portable US
Measured: 4th week
SNP (FTO) detection
measure by polymerase chain reaction (PCR) in present or absence of A and T allele
Measured: 1st week
Serum albumin
measured in serum in g/dL
Measured: 4th week
Serum albumin
measured in serum in g/dL
Measured: 8th week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2020
- Study start1 Mar 2019
- Primary completion1 Feb 2023
- Study completion14 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bariatric SurgeryStudies 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
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- randomized
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Federal University of Minas Gerais
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jacqueline Isaura Alvarez Leite, Federal University of Minas Gerais
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04510389
- Sponsor's protocol ID
- JLeite
- Status last verified
- Feb 2023
- First submitted
- 18 Jan 2019
- Last updated
- 16 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Whey Protein Supplementation on Body Composition, Energy Expenditure and Biochemical Parameters of Patients Submitted to Bariatric Surgery
- ClinicalTrials.gov ID
- NCT04510389
- Acronym / sponsor ID
- JLeite
- Conditions
- Bariatric Surgery, Sarcopenia
- Keywords
- obesity, sarcopenia, bariatric surgery, protein
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Federal University of Minas GeraisUniversity, hospital or other
- Study start
- 1 Mar 2019 (actual)
- Primary completion
- 1 Feb 2023 (actual)
- Study completion
- 14 Feb 2023 (actual)
- First posted
- 12 Aug 2020 (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.
Obesity is a metabolic disorder, characterized by an increase in the body's fat mass, which will reflect an increase in total body weight. In Brazil, overweight accounts for 53.8% of the population, and of these 18.9% are obese. Surgical treatment is currently the most successful method for weight loss in patients with Grade III obesity and reduced associated morbidities. The general objective is to evaluate genetic, inflammatory, and dietary factors that would influence weight loss and the appearance of protein deficiency or sarcopenia in patients undergoing bariatric surgery and to evaluate the effects of protein supplementation for 8 weeks after the 18th postoperative month in the parameters evaluated. The study has a randomized, placebo-controlled, double-masked model. The patients will be selected in two bariatric surgery services accredited by the Brazilian Health Unic System (SUS) in the city of Belo Horizonte, Brazil.
The project has already been approved by the Brazilian Ethics committee CONEP/UFMG by nº. 75415317.8.0000.5149. Patients of both sexes over 20 years of age will be included, attending the hospitals of the project with regular follow-up in the postoperative period. Data on anthropometry, body composition, muscle strength, energy expenditure, and inflammatory profile will be collected. The data will be correlated with the evaluation of the presence of genetic polymorphisms.
Detailed description
Specific objectives:
It is also objective to evaluate:
- To observe the food consumption between 18 and 24 months of surgery with respect to protein and caloric intake;
- Evolution of weight loss, lean mass, fat mass and metabolic rate before and after supplementation with WP or placebo;
- Changes in protein status (assessed by muscle strength and serum levels of total protein, albumin, prealbumin, ferritin, hemoglobin) before and after supplementation with WP or placebo
- The inflammatory blood profile (assessed by cytokine levels and before and after supplementation with WP or placebo).
- The influence of the rS9939609 polymorphism of the FTO gene on the nutritional status, biochemical and inflammatory parameters in the postoperative (after 18 months) of surgery;
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- randomized
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Dietary Supplement: Maltodextrinvolunteers will receive 28 sachets containing 30g of maltodextrin to be consumed daily for 4 weeks. After that they will return to the 4-week visit and assessment when they will receive 28 sachets for the next 28 days when will return for the final vist and assessment. |
| Whey | Experimental | Dietary Supplement: Wheyvolunteers will receive 28 sachets containing 30g of whey protein to be consumed daily for 4 weeks. After that they will return to the 4-week visit and assessment when they will receive 28 sachets for the next 28 days when will return for the final vist and assessment. |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Patients of both sexes over 20 years of age
- Patients with regular follow-up in the postoperative period.
Key exclusion criteria (5 listed)
- Patients with debilitating chronic diseases
- Severe vomiting
- Submitted to other surgical procedures before 18 months of surgery
- Patient with prostheses
- Use or introduction of drugs immunosuppressants or affecting metabolism
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 |
|---|---|---|
| MaltodextrinBariatric patients with or without sarcopenia receiving maltodextrin | Dietary supplement | Placebo |
| WheyBariatric patients with or without sarcopenia receiving whey protein | Dietary supplement | Whey |
Primary outcome
Body Weight variation
Time frame: 8th week
measured in scale presented in kg
Muscle mass
Time frame: 8th week
measure by portable US
6 secondary outcomes
Body Weight variation
Time frame: 4th week
Resting metabolic rate
Time frame: 4th week
Muscle mass
Time frame: 4th week
SNP (FTO) detection
Time frame: 1st week
Serum albumin
Time frame: 4th week
Serum albumin
Time frame: 8th week
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 16 Feb 2023.
- 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 Maltodextrin and Whey in people with Bariatric Surgery and Sarcopenia, run by Federal University of Minas Gerais at 1 site in Brazil.
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 2 inclusion and 5 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 16 Feb 2023. 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 Brazil. 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?
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?
Body Weight variation (time frame: 8th week). The study lists 2 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 16 Feb 2023.