Bariatric Surgery CandidatePROMISENCT05570474
Effect of Protein Supplementation on Fat Free Mass Preservation After Bariatric Surgery
A study testing Protein drink supplementation in people with Bariatric Surgery Candidate and Protein Deficiency, run by Maasstad Hospital at 1 site in Netherlands.
Trial summary
This double blind randomized placebo controlled trial investigates the effect of protein supplementation on fat free mass loss in patients who underwent a Roux-en-Y gastric bypass. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Bariatric Surgery Candidate, Protein Deficiency, Muscle Loss
- What is being tested?
- Protein drink supplementation
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 266 participants
- Where
- 1 siteNetherlands
- Study dates
- 1 Sep 2022to 1 Dec 2024
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- - Scheduled for a laparoscopic Roux-en-Y Gastric Bypass
- Age 18 - 65 years
- Body Mass Index ≥ 35 with the presence of severe comorbidity related to morbid obesity (diabetes mellitus type 2, obstructive sleep apnoea syndrome (OSAS), hypertension, etc.) or a BMI ≥ 40 with or without the presence of severe comorbidity related to morbid obesity
- Written informed consent
Who cannot join
- - Revisional bariatric surgery
- A protein-restricted diet for medical reasons
- Diagnosis of a (neuro-) muscular disease
- Inability to undergo MF-BIA (i.e. pregnancy, pacemaker)
- Allergy to any of the ingredients of either the protein or the placebo shake
Trial locations and contacts
1 site in 1 country.
Netherlands1 site, 1 recruiting
- Recruiting
Maasstad Hospital
Rotterdam, South Holland, 3079DZ
Taselaar, MD
Rene Klaassen, MD
About this study
Official title: Effect of Protein Supplementation on Fat Free Mass Preservation After Bariatric Surgery, a Randomized Double-blind Placebo-controlled Trial.
This double blind randomized placebo controlled trial investigates the effect of protein supplementation on fat free mass loss in patients who underwent a Roux-en-Y gastric bypass.
Read the detailed description
Rationale: Protein malnutrition is a severe complication of bariatric surgery and leads to increased morbidity. Previous studies have shown that protein intake and physical activity are the most important factors in the preservation of fat free mass during weight loss. Low protein intake is very common in patients undergoing bariatric surgery despite dietary counselling. Protein powder supplements might help patients to achieve the protein intake recommendations after bariatric surgery and could therefore contribute to preserve fat free mass.
Objective: The main aim of this study is to assess the effect of a daily consumed clear protein powder shake during the first six months after bariatric surgery on fat free mass loss in the first twelve months after laparoscopic Roux-en-Y gastric bypass (LRYGB).
Study design: Double-blind randomized placebo-controlled intervention study
Study population: Patients undergoing LRYGB at the bariatric expertise center for obesity of the Maasstad Hospital Rotterdam.
Intervention and procedure: Inclusion will take place at the outpatient clinic of the bariatric expertise center for obesity of the Maasstad Hospital. Patients will be randomly assigned to either the intervention or control group before surgery. The intervention group will receive a clear protein powder shake of 200 ml containing 20 grams of whey protein which should be taken daily during the first six months after LRYGB. The control group will receive an isocaloric, clear, placebo shake containing maltodextrine.
Main study parameters/endpoints: The main study parameter is the percentage fat free mass loss six months after surgery, calculated as fat free mass loss (kg) divided by total weight loss (kg) x 100%. Fat free mass will be assessed by multi-frequency bioelectrical impedance analysis (MF-BIA). Secondary parameters are percentage fat free mass loss, total weight loss, fat mass loss, BMI, hand grip strength, total protein intake and its progression over time, measured at baseline, 3, 6 and 12 months of follow-up.
Nature and extent of the burden and risks associated with participation, benefit and group relatedness: No additional outpatient visits will be required for study participants. A three day food diary and physical activity questionnaire must be filled out by all study participants at five regular follow-up moments. Body composition and handgrip strength will be assessed during these visits. All study participants will be asked to drink a daily shake, either protein or placebo, integrated in their postoperative diet. Study participants will receive information about the changes in body composition after surgery which is considered to be a significant benefit for patients participating in this study. The risk of participation is considered low. The risk consists of a possible allergic reaction to either the protein shake or the placebo.
- Conditions
- Bariatric Surgery Candidate, Protein Deficiency, Muscle Loss
- Being tested
- Protein drink supplementation, Placebo
- Keywords
- bariatric surgery, RYGB, Roux-en-Y gastric bypass, protein supplementation, fat free mass, muscle mass
- Medical subject headings
- Protein Deficiency, Muscular Atrophy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Protein drink supplementationDietary supplement
Daily drink containing 20 grams of whey protein, dissolved in 200mL water.
PlaceboDietary supplement
Daily placebo drink
| Study group | Role | What they receive |
|---|---|---|
| Protein | Experimental | Daily protein shake during 6 months after surgery Receives: Dietary Supplement: Protein drink supplementation |
| Control | Placebo comparator | Daily placebo shake during 6 months after surgery Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fat Free mass loss
Main study endpoint is percentage fat free mass loss at 6 months defined as fat free mass loss (kg) divided by total weight loss (kg) x 100%. Fat free mass will be assessed using the Seca® MBCA 515, which is a multi-frequency bio-electrical impedance analysis (MF-BIA). MF-BIA is an easy and non-invasive measurement tool and has been validated in morbid obese patients (13, 14). BIA measurements will be conducted under standardized circumstances. Patients can wear light clothes, have to empty their pockets and have to have an empty bladder. Patients will be asked to have no intensive physical activity and to have no food and fluid intake two hours prior to the measurements to minimalize bias.
Measured: Change of fat free mass at 6 months post surgery compared to pre surgery
Secondary outcomes (6)
percentage of fat free mass loss,
measured by BIA
Measured: Change of percentage fat free mass at 6 months post surgery compared to pre surgery
total weight loss,
measured by BIA
Measured: pre surgery, 1 month after surgery, 3 months after surgery, 6 months after surgery, 12 months after surgery
fat mass loss,
measured by BIA
Measured: Change of fat mass at 6 months post surgery compared to pre surgery
BMI
measured by BIA
Measured: Change of BMI at 6 months post surgery compared to pre surgery
hand grip strength,
measured by hand grip strength device
Measured: Change of hand grip strength at 6 months post surgery compared to pre surgery
total protein intake
measured by 3 day food diary
Measured: Change of total protein intake at 6 months post surgery compared to pre surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2022
- Study start1 Sep 2022
- Primary completion1 Apr 2024 (estimated)
- Study completion1 Dec 2024 (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 Bariatric Surgery CandidateStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants are randomly allocated to either protein group or placebo group.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 266 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Maasstad Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Klaassen, MD, Principal investigator, Maasstad Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05570474
- Sponsor's protocol ID
- L2022059
- Acronym
- PROMISE
- Status last verified
- Mar 2024
- First submitted
- 26 Sep 2022
- Last updated
- 13 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Taselaar AE, Boes AJ, de Bruin RWF, Kuijper TM, Van Lancker K, van der Harst E, Klaassen RA. PROMISE: effect of protein supplementation on fat-free mass preservation after bariatric surgery, a randomized double-blind placebo-controlled trial. Trials. 2023 Nov 9;24(1):717. doi: 10.1186/s13063-023-07654-w.
PubMed 37946272
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Protein Supplementation on Fat Free Mass Preservation After Bariatric Surgery, a Randomized Double-blind Placebo-controlled Trial.
- ClinicalTrials.gov ID
- NCT05570474
- Acronym / sponsor ID
- PROMISE / L2022059
- Conditions
- Bariatric Surgery Candidate, Protein Deficiency, Muscle Loss
- Keywords
- bariatric surgery, RYGB, Roux-en-Y gastric bypass, protein supplementation, fat free mass, muscle mass
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 266 participants (estimated)
- Lead sponsor
- Maasstad HospitalUniversity, hospital or other
- Study start
- 1 Sep 2022 (actual)
- Primary completion
- 1 Apr 2024 (estimated)
- Study completion
- 1 Dec 2024 (estimated)
- First posted
- 6 Oct 2022 (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.
This double blind randomized placebo controlled trial investigates the effect of protein supplementation on fat free mass loss in patients who underwent a Roux-en-Y gastric bypass.
Detailed description
Rationale: Protein malnutrition is a severe complication of bariatric surgery and leads to increased morbidity. Previous studies have shown that protein intake and physical activity are the most important factors in the preservation of fat free mass during weight loss. Low protein intake is very common in patients undergoing bariatric surgery despite dietary counselling. Protein powder supplements might help patients to achieve the protein intake recommendations after bariatric surgery and could therefore contribute to preserve fat free mass.
Objective: The main aim of this study is to assess the effect of a daily consumed clear protein powder shake during the first six months after bariatric surgery on fat free mass loss in the first twelve months after laparoscopic Roux-en-Y gastric bypass (LRYGB).
Study design: Double-blind randomized placebo-controlled intervention study
Study population: Patients undergoing LRYGB at the bariatric expertise center for obesity of the Maasstad Hospital Rotterdam.
Intervention and procedure: Inclusion will take place at the outpatient clinic of the bariatric expertise center for obesity of the Maasstad Hospital. Patients will be randomly assigned to either the intervention or control group before surgery. The intervention group will receive a clear protein powder shake of 200 ml containing 20 grams of whey protein which should be taken daily during the first six months after LRYGB. The control group will receive an isocaloric, clear, placebo shake containing maltodextrine.
Main study parameters/endpoints: The main study parameter is the percentage fat free mass loss six months after surgery, calculated as fat free mass loss (kg) divided by total weight loss (kg) x 100%. Fat free mass will be assessed by multi-frequency bioelectrical impedance analysis (MF-BIA). Secondary parameters are percentage fat free mass loss, total weight loss, fat mass loss, BMI, hand grip strength, total protein intake and its progression over time, measured at baseline, 3, 6 and 12 months of follow-up.
Nature and extent of the burden and risks associated with participation, benefit and group relatedness: No additional outpatient visits will be required for study participants. A three day food diary and physical activity questionnaire must be filled out by all study participants at five regular follow-up moments. Body composition and handgrip strength will be assessed during these visits. All study participants will be asked to drink a daily shake, either protein or placebo, integrated in their postoperative diet. Study participants will receive information about the changes in body composition after surgery which is considered to be a significant benefit for patients participating in this study. The risk of participation is considered low. The risk consists of a possible allergic reaction to either the protein shake or the placebo.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- Model description
- Participants are randomly allocated to either protein group or placebo group.
| Arm | Type | Receives |
|---|---|---|
| Protein | Experimental | Dietary Supplement: Protein drink supplementationDaily protein shake during 6 months after surgery |
| Control | Placebo comparator | Dietary Supplement: PlaceboDaily placebo shake during 6 months after surgery |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- - Scheduled for a laparoscopic Roux-en-Y Gastric Bypass
- Age 18 - 65 years
- Body Mass Index ≥ 35 with the presence of severe comorbidity related to morbid obesity (diabetes mellitus type 2, obstructive sleep apnoea syndrome (OSAS), hypertension, etc.) or a BMI ≥ 40 with or without the presence of severe comorbidity related to morbid obesity
- Written informed consent
Key exclusion criteria (5 listed)
- - Revisional bariatric surgery
- A protein-restricted diet for medical reasons
- Diagnosis of a (neuro-) muscular disease
- Inability to undergo MF-BIA (i.e. pregnancy, pacemaker)
- Allergy to any of the ingredients of either the protein or the placebo shake
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 |
|---|---|---|
| Protein drink supplementationDaily drink containing 20 grams of whey protein, dissolved in 200mL water. | Dietary supplement | Protein |
| PlaceboDaily placebo drink | Dietary supplement | Control |
Primary outcome
Fat Free mass loss
Time frame: Change of fat free mass at 6 months post surgery compared to pre surgery
Main study endpoint is percentage fat free mass loss at 6 months defined as fat free mass loss (kg) divided by total weight loss (kg) x 100%. Fat free mass will be assessed using the Seca® MBCA 515, which is a multi-frequency bio-electrical impedance analysis (MF-BIA). MF-BIA is an easy and non-invasive measurement tool and has been validated in morbid obese patients (13, 14). BIA measurements will be conducted under standardized circumstances. Patients can wear light clothes, have to empty their pockets and have to have an empty bladder. Patients will be asked to have no intensive physical activity and to have no food and fluid intake two hours prior to the measurements to minimalize bias.
6 secondary outcomes
percentage of fat free mass loss,
Time frame: Change of percentage fat free mass at 6 months post surgery compared to pre surgery
total weight loss,
Time frame: pre surgery, 1 month after surgery, 3 months after surgery, 6 months after surgery, 12 months after surgery
fat mass loss,
Time frame: Change of fat mass at 6 months post surgery compared to pre surgery
BMI
Time frame: Change of BMI at 6 months post surgery compared to pre surgery
hand grip strength,
Time frame: Change of hand grip strength at 6 months post surgery compared to pre surgery
total protein intake
Time frame: Change of total protein intake at 6 months post surgery compared to pre surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2024.
- Derived from this study: PubMed 37946272Taselaar AE, Boes AJ, de Bruin RWF, Kuijper TM, Van Lancker K, van der Harst E, Klaassen RA. PROMISE: effect of protein supplementation on fat-free mass preservation after bariatric surgery, a randomized double-blind placebo-controlled trial. Trials. 2023 Nov 9;24(1):717. doi: 10.1186/s13063-023-07654-w.
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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.
Klaassen, MD principal investigator
Maasstad Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Protein drink supplementation in people with Bariatric Surgery Candidate and Protein Deficiency, run by Maasstad Hospital at 1 site in Netherlands.
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 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: status not confirmed, as of the sponsor's last update on 13 Mar 2024. 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 Netherlands. 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 Taselaar, MD (0102912246 ext. 0031, secretariaatbariatrie@maasstadziekenhuis.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fat Free mass loss (time frame: Change of fat free mass at 6 months post surgery compared to pre surgery). 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 NCT05570474, 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 13 Mar 2024.