Bariatric Surgery CandidateNCT03999632
Effects of Wolffia Globosa (Mankai) in Patients Undergoing Bariatric Surgery.
A study testing Dietary modification with introduction of Mankai in people with Bariatric Surgery Candidate and Diet Modification, run by Cleveland Clinic Florida at 1 site in United States.
Trial summary
Candidates to bariatric surgery at The Bariatric and Metabolic Institute at Cleveland Clinic Florida are prescribed a high protein liquid diet for two weeks preoperatively and 2 weeks postoperatively. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bariatric Surgery Candidate, Diet Modification
- What is being tested?
- Dietary modification with introduction of Mankai
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Aug 2019to 1 Dec 2020
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients that will undergo sleeve gastrectomy.
Who cannot join
- Age below 18 years
- American Society of Anesthesiologist (ASA) class IV or V
- Patients using Vitamin-K antagonists
- Patients with documented coagulopathies.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Aquatic Plant Protein Source Wolffia Globosa (Mankai) on Weight Loss, Cardiometabolic State, and Patient's Satisfaction During the Preoperative Dietary Intervention Period in Patients Undergoing Bariatric Surgery.
Candidates to bariatric surgery at The Bariatric and Metabolic Institute at Cleveland Clinic Florida are prescribed a high protein liquid diet for two weeks preoperatively and 2 weeks postoperatively. Whether Wolffia Globosa (Mankai), a plant based wholesome food, can serve as a natural alternative to liquid diet during the 2 week pre-operation and 2 weeks postoperation liquid based diet, is unknown.
The investigators aim to address the effect of daily Wolffia Globosa (Mankai) administration on morbid/severely-obese patients during the 2 week pre-operative period and 2 weeks postoperatively as compared to iso protein-iso caloric shake source on the following parameters
Read the detailed description
This study is a prospective study involving patients selected for elective surgery. Patients undergoing bariatric surgery will be enrolled in this study and have several parameters checked as explained below. Patients selected and consented for elective bariatric surgery will be recruited in the Bariatric and Metabolic Institute to participate in this study and will undergo standard of care. The investigators will enroll approximately 120 candidates during a 6 months (~5 a week) period. Patients will be randomized to the A. control group: 3 traditional shakes or B. intervention group: 2 traditional shakes and 1 daily administration of substituting iso-protein green Wolffia Globosa (Mankai) Shake (4 frozen cubes of Wolffia Globosa (Mankai) equal to 20 grams of dry Wolffia Globosa (Mankai). Each shake will provide equivalent carbohydrate, calories and protein levels from the respective source. As part of our routine pre and postoperative screening and follow up protocol, the investigators will collect anthropometric and clinical data on all patients, including standard of care blood samples collected at 2 weeks pre operatively, surgery day and at 2 months postoperatively
- Conditions
- Bariatric Surgery Candidate, Diet Modification
- Being tested
- Dietary modification with introduction of Mankai
- Keywords
- Bariatric surgery, Sleeve gastrectomy, Preoperative diet, Hepatic steatosis, Wolffia Globosa, Hyperglycemia
- Medical subject headings
- Fatty Liver, Hyperglycemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dietary modification with introduction of MankaiOther
Substituting the standard high protein, low carbohydrate preoperative shake during the preoperative liquid diet with Wolffia Globosa (Mankai) shake consisting of 16 oz of skim milk + 1 frozen cube of Wolffia Globosa (Mankai) +/- sugar substitute.
| Study group | Role | What they receive |
|---|---|---|
| Mankai Group | Experimental | The pre-operative liquid diet will be started two weeks before surgery date for both groups. During the first week patients in group A (Wolffia Globosa) will be allowed to have two meals a day and one protein shake (Wolffia Globosa) of 16 oz. Each meal will consist of 3-5 oz of lean protein (Chicken, turkey or fish) and one cup of vegetables or salad. During the second week, patients will drink one protein shake of 16 oz (Wolffia Globosa) as a meal replacement, three times per day and will not be allowed to eat solid food. Patients will also be allowed to Drink clear liquids in between protein shakes. Receives: Other: Dietary modification with introduction of Mankai |
| Control Group | No intervention | The pre-operative liquid diet will be started two weeks before surgery date for both groups. During the first week patients in group B (Control) will be allowed to have two meals a day and one protein shake (Control) of 16 oz. Each meal will consist of 3-5 oz of lean protein (Chicken, turkey or fish) and one cup of vegetables or salad. During the second week, patients will drink one protein shake of 16 oz (Control) as a meal replacement, three times per day and will not be allowed to eat solid food. Patients will also be allowed to Drink clear liquids in between protein shakes. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient's Satiety with Wolffia Globosa (Mankai) shake measured with a QUALITY OF ALIMENTATION QUESTIONNAIRE
QUALITY OF ALIMENTATION QUESTIONNAIRE is a questionnaire with 1 open ended question, 4 yes/no questions, and three 0-5 questions with 5 being the highest level
Measured: 2 weeks
Glucose control in patients with previous Type 2 Diabetes Mellitus diagnosis by fasting glucose and Hgb A1c
Glucose control in patients with previous Type 2 Diabetes Mellitus diagnosis (T2DM). measure by fasting glucose and Hgb A1c
Measured: 2 weeks
Patient's liking with Wolffia Globosa (Mankai) shake measured with a questionnaire
Patient's liking with Wolffia Globosa (Mankai) shake. measured with a questionnaire
Measured: 2 weeks
Patient's tolerance with Wolffia Globosa (Mankai) shake. measured with a questionnaire
QUALITY OF ALIMENTATION QUESTIONNAIRE is a questionnaire with 1 open ended question, 4 yes/no questions, and three 0-5 questions with 5 being the highest level
Measured: 2 weeks
Patient's compliance with Wolffia Globosa (Mankai) shake. measured with a questionnaire
QUALITY OF ALIMENTATION QUESTIONNAIRE is a questionnaire with 1 open ended question, 4 yes/no questions, and three 0-5 questions with 5 being the highest level
Measured: 2 weeks
Secondary outcomes (7)
Metabolic and nutritional effects of Wolffia Globosa (Mankai) in patients undergoing bariatric surgery by serum measurements
Serum levels of the common nutritional parameters will be checked before and after the intervention
Measured: 2.5 months
Adverse effect by patient report and clinical follow up
Adverse effect patient report and clinical follow up
Measured: 2.5 months
Fat% (via Bioelectrical Impedance)
Fat% (via Bioelectrical Impedance)
Measured: 2.5 months
Fatty liver infiltration by Ultrasound
Fatty liver infiltration by Ultrasound
Measured: 2.5 months
Patient's adherence by food diary
Patient's adherence by food diary
Measured: 2.5 months
Satisfaction of Patients by specific questionnaire
Satisfaction of Patients. by specific questionnaire
Measured: 2.5 months
Free Fat Mass (via Bioelectrical Impedance)
Free Fat Mass (via Bioelectrical Impedance)
Measured: 2.5 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2019
- Study start1 Aug 2019
- Primary completion1 Oct 2020
- Study completion1 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized controlled trial
- Masking
- None (open label)
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cleveland Clinic Florida
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Emanuele LoMenzo, Cleveland Clinic Florida
- Investigators
- Emanuele Lo Menzo, MD, Principal investigator, Cleveland Clinic Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03999632
- Sponsor's protocol ID
- FLA 18-070
- Status last verified
- Feb 2021
- First submitted
- 17 Apr 2019
- Last updated
- 4 Feb 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Confidentiality and Privacy: Information about study subjects will be kept confidential and managed according to the Health Insurance Portability and Accountability Act of 1996 (HIPAA). Source Documents: Source data will include the electronic health record for patient demographics, vitals, and basic laboratory results. Dictated operative notes will be maintained within the EHR as well. Lab results of inflammatory markers will be kept out of the EHR and kept in a secure file on the Cleveland Clinic server. Records Retention: The investigators will retain study essential documents for at least six years after completion of the research and are accessible for inspection by authorized representatives at reasonable times and in a reasonable manner.
Publications
Gilani GS, Cockell KA, Sepehr E. Effects of antinutritional factors on protein digestibility and amino acid availability in foods. J AOAC Int. 2005 May-Jun;88(3):967-87.
PubMed 16001874Sarwar Gilani G, Wu Xiao C, Cockell KA. Impact of antinutritional factors in food proteins on the digestibility of protein and the bioavailability of amino acids and on protein quality. Br J Nutr. 2012 Aug;108 Suppl 2:S315-32. doi: 10.1017/S0007114512002371.
PubMed 23107545Pan A, Sun Q, Bernstein AM, Schulze MB, Manson JE, Stampfer MJ, Willett WC, Hu FB. Red meat consumption and mortality: results from 2 prospective cohort studies. Arch Intern Med. 2012 Apr 9;172(7):555-63. doi: 10.1001/archinternmed.2011.2287. Epub 2012 Mar 12.
PubMed 22412075Chalvon-Demersay T, Azzout-Marniche D, Arfsten J, Egli L, Gaudichon C, Karagounis LG, Tome D. A Systematic Review of the Effects of Plant Compared with Animal Protein Sources on Features of Metabolic Syndrome. J Nutr. 2017 Mar;147(3):281-292. doi: 10.3945/jn.116.239574. Epub 2017 Jan 25.
PubMed 28122929Micha R, Wallace SK, Mozaffarian D. Red and processed meat consumption and risk of incident coronary heart disease, stroke, and diabetes mellitus: a systematic review and meta-analysis. Circulation. 2010 Jun 1;121(21):2271-83. doi: 10.1161/CIRCULATIONAHA.109.924977. Epub 2010 May 17.
PubMed 20479151Wang X, Lin X, Ouyang YY, Liu J, Zhao G, Pan A, Hu FB. Red and processed meat consumption and mortality: dose-response meta-analysis of prospective cohort studies. Public Health Nutr. 2016 Apr;19(5):893-905. doi: 10.1017/S1368980015002062. Epub 2015 Jul 6.
PubMed 26143683Pan A, Sun Q, Bernstein AM, Schulze MB, Manson JE, Willett WC, Hu FB. Red meat consumption and risk of type 2 diabetes: 3 cohorts of US adults and an updated meta-analysis. Am J Clin Nutr. 2011 Oct;94(4):1088-96. doi: 10.3945/ajcn.111.018978. Epub 2011 Aug 10.
PubMed 21831992Malik VS, Li Y, Tobias DK, Pan A, Hu FB. Dietary Protein Intake and Risk of Type 2 Diabetes in US Men and Women. Am J Epidemiol. 2016 Apr 15;183(8):715-28. doi: 10.1093/aje/kwv268. Epub 2016 Mar 28.
PubMed 27022032Song M, Fung TT, Hu FB, Willett WC, Longo VD, Chan AT, Giovannucci EL. Association of Animal and Plant Protein Intake With All-Cause and Cause-Specific Mortality. JAMA Intern Med. 2016 Oct 1;176(10):1453-1463. doi: 10.1001/jamainternmed.2016.4182.
PubMed 27479196Derbyshire EJ. Flexitarian Diets and Health: A Review of the Evidence-Based Literature. Front Nutr. 2017 Jan 6;3:55. doi: 10.3389/fnut.2016.00055. eCollection 2016.
PubMed 28111625Edelman M, Colt M. Nutrient Value of Leaf vs. Seed. Front Chem. 2016 Jul 21;4:32. doi: 10.3389/fchem.2016.00032. eCollection 2016.
PubMed 27493937Rizzo G, Lagana AS, Rapisarda AM, La Ferrera GM, Buscema M, Rossetti P, Nigro A, Muscia V, Valenti G, Sapia F, Sarpietro G, Zigarelli M, Vitale SG. Vitamin B12 among Vegetarians: Status, Assessment and Supplementation. Nutrients. 2016 Nov 29;8(12):767. doi: 10.3390/nu8120767.
PubMed 27916823
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Aquatic Plant Protein Source Wolffia Globosa (Mankai) on Weight Loss, Cardiometabolic State, and Patient's Satisfaction During the Preoperative Dietary Intervention Period in Patients Undergoing Bariatric Surgery.
- ClinicalTrials.gov ID
- NCT03999632
- Acronym / sponsor ID
- FLA 18-070
- Conditions
- Bariatric Surgery Candidate, Diet Modification
- Keywords
- Bariatric surgery, Sleeve gastrectomy, Preoperative diet, Hepatic steatosis, Wolffia Globosa, Hyperglycemia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 3 participants (actual)
- Lead sponsor
- Cleveland Clinic FloridaUniversity, hospital or other
- Study start
- 1 Aug 2019 (actual)
- Primary completion
- 1 Oct 2020 (actual)
- Study completion
- 1 Dec 2020 (actual)
- First posted
- 27 Jun 2019 (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.
Candidates to bariatric surgery at The Bariatric and Metabolic Institute at Cleveland Clinic Florida are prescribed a high protein liquid diet for two weeks preoperatively and 2 weeks postoperatively. Whether Wolffia Globosa (Mankai), a plant based wholesome food, can serve as a natural alternative to liquid diet during the 2 week pre-operation and 2 weeks postoperation liquid based diet, is unknown.
The investigators aim to address the effect of daily Wolffia Globosa (Mankai) administration on morbid/severely-obese patients during the 2 week pre-operative period and 2 weeks postoperatively as compared to iso protein-iso caloric shake source on the following parameters
Detailed description
This study is a prospective study involving patients selected for elective surgery. Patients undergoing bariatric surgery will be enrolled in this study and have several parameters checked as explained below. Patients selected and consented for elective bariatric surgery will be recruited in the Bariatric and Metabolic Institute to participate in this study and will undergo standard of care. The investigators will enroll approximately 120 candidates during a 6 months (~5 a week) period. Patients will be randomized to the A. control group: 3 traditional shakes or B. intervention group: 2 traditional shakes and 1 daily administration of substituting iso-protein green Wolffia Globosa (Mankai) Shake (4 frozen cubes of Wolffia Globosa (Mankai) equal to 20 grams of dry Wolffia Globosa (Mankai). Each shake will provide equivalent carbohydrate, calories and protein levels from the respective source. As part of our routine pre and postoperative screening and follow up protocol, the investigators will collect anthropometric and clinical data on all patients, including standard of care blood samples collected at 2 weeks pre operatively, surgery day and at 2 months postoperatively
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| Mankai Group | Experimental | Other: Dietary modification with introduction of MankaiThe pre-operative liquid diet will be started two weeks before surgery date for both groups. During the first week patients in group A (Wolffia Globosa) will be allowed to have two meals a day and one protein shake (Wolffia Globosa) of 16 oz. Each meal will consist of 3-5 oz of lean protein (Chicken, turkey or fish) and one cup of vegetables or salad. During the second week, patients will drink one protein shake of 16 oz (Wolffia Globosa) as a meal replacement, three times per day and will not be allowed to eat solid food. Patients will also be allowed to Drink clear liquids in between protein shakes. |
| Control Group | No intervention | –The pre-operative liquid diet will be started two weeks before surgery date for both groups. During the first week patients in group B (Control) will be allowed to have two meals a day and one protein shake (Control) of 16 oz. Each meal will consist of 3-5 oz of lean protein (Chicken, turkey or fish) and one cup of vegetables or salad. During the second week, patients will drink one protein shake of 16 oz (Control) as a meal replacement, three times per day and will not be allowed to eat solid food. Patients will also be allowed to Drink clear liquids in between protein shakes. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients that will undergo sleeve gastrectomy.
Key exclusion criteria (4 listed)
- Age below 18 years
- American Society of Anesthesiologist (ASA) class IV or V
- Patients using Vitamin-K antagonists
- Patients with documented coagulopathies.
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 |
|---|---|---|
| Dietary modification with introduction of MankaiSubstituting the standard high protein, low carbohydrate preoperative shake during the preoperative liquid diet with Wolffia Globosa (Mankai) shake consisting of 16 oz of skim milk + 1 frozen cube of Wolffia Globosa (Mankai) +/- sugar substitute. | Other | Mankai Group |
Primary outcome
Patient's Satiety with Wolffia Globosa (Mankai) shake measured with a QUALITY OF ALIMENTATION QUESTIONNAIRE
Time frame: 2 weeks
QUALITY OF ALIMENTATION QUESTIONNAIRE is a questionnaire with 1 open ended question, 4 yes/no questions, and three 0-5 questions with 5 being the highest level
Glucose control in patients with previous Type 2 Diabetes Mellitus diagnosis by fasting glucose and Hgb A1c
Time frame: 2 weeks
Glucose control in patients with previous Type 2 Diabetes Mellitus diagnosis (T2DM). measure by fasting glucose and Hgb A1c
Patient's liking with Wolffia Globosa (Mankai) shake measured with a questionnaire
Time frame: 2 weeks
Patient's liking with Wolffia Globosa (Mankai) shake. measured with a questionnaire
Patient's tolerance with Wolffia Globosa (Mankai) shake. measured with a questionnaire
Time frame: 2 weeks
QUALITY OF ALIMENTATION QUESTIONNAIRE is a questionnaire with 1 open ended question, 4 yes/no questions, and three 0-5 questions with 5 being the highest level
Patient's compliance with Wolffia Globosa (Mankai) shake. measured with a questionnaire
Time frame: 2 weeks
QUALITY OF ALIMENTATION QUESTIONNAIRE is a questionnaire with 1 open ended question, 4 yes/no questions, and three 0-5 questions with 5 being the highest level
7 secondary outcomes
Metabolic and nutritional effects of Wolffia Globosa (Mankai) in patients undergoing bariatric surgery by serum measurements
Time frame: 2.5 months
Adverse effect by patient report and clinical follow up
Time frame: 2.5 months
Fat% (via Bioelectrical Impedance)
Time frame: 2.5 months
Fatty liver infiltration by Ultrasound
Time frame: 2.5 months
Patient's adherence by food diary
Time frame: 2.5 months
Satisfaction of Patients by specific questionnaire
Time frame: 2.5 months
Free Fat Mass (via Bioelectrical Impedance)
Time frame: 2.5 months
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 4 Feb 2021.
- Background: PubMed 16001874Gilani GS, Cockell KA, Sepehr E. Effects of antinutritional factors on protein digestibility and amino acid availability in foods. J AOAC Int. 2005 May-Jun;88(3):967-87.
- Background: PubMed 23107545Sarwar Gilani G, Wu Xiao C, Cockell KA. Impact of antinutritional factors in food proteins on the digestibility of protein and the bioavailability of amino acids and on protein quality. Br J Nutr. 2012 Aug;108 Suppl 2:S315-32. doi: 10.1017/S0007114512002371.
- Background: PubMed 22412075Pan A, Sun Q, Bernstein AM, Schulze MB, Manson JE, Stampfer MJ, Willett WC, Hu FB. Red meat consumption and mortality: results from 2 prospective cohort studies. Arch Intern Med. 2012 Apr 9;172(7):555-63. doi: 10.1001/archinternmed.2011.2287. Epub 2012 Mar 12.
- Background: PubMed 28122929Chalvon-Demersay T, Azzout-Marniche D, Arfsten J, Egli L, Gaudichon C, Karagounis LG, Tome D. A Systematic Review of the Effects of Plant Compared with Animal Protein Sources on Features of Metabolic Syndrome. J Nutr. 2017 Mar;147(3):281-292. doi: 10.3945/jn.116.239574. Epub 2017 Jan 25.
- Background: PubMed 20479151Micha R, Wallace SK, Mozaffarian D. Red and processed meat consumption and risk of incident coronary heart disease, stroke, and diabetes mellitus: a systematic review and meta-analysis. Circulation. 2010 Jun 1;121(21):2271-83. doi: 10.1161/CIRCULATIONAHA.109.924977. Epub 2010 May 17.
- Background: PubMed 26143683Wang X, Lin X, Ouyang YY, Liu J, Zhao G, Pan A, Hu FB. Red and processed meat consumption and mortality: dose-response meta-analysis of prospective cohort studies. Public Health Nutr. 2016 Apr;19(5):893-905. doi: 10.1017/S1368980015002062. Epub 2015 Jul 6.
- Background: PubMed 21831992Pan A, Sun Q, Bernstein AM, Schulze MB, Manson JE, Willett WC, Hu FB. Red meat consumption and risk of type 2 diabetes: 3 cohorts of US adults and an updated meta-analysis. Am J Clin Nutr. 2011 Oct;94(4):1088-96. doi: 10.3945/ajcn.111.018978. Epub 2011 Aug 10.
- Background: PubMed 27022032Malik VS, Li Y, Tobias DK, Pan A, Hu FB. Dietary Protein Intake and Risk of Type 2 Diabetes in US Men and Women. Am J Epidemiol. 2016 Apr 15;183(8):715-28. doi: 10.1093/aje/kwv268. Epub 2016 Mar 28.
- Background: PubMed 27479196Song M, Fung TT, Hu FB, Willett WC, Longo VD, Chan AT, Giovannucci EL. Association of Animal and Plant Protein Intake With All-Cause and Cause-Specific Mortality. JAMA Intern Med. 2016 Oct 1;176(10):1453-1463. doi: 10.1001/jamainternmed.2016.4182.
- Background: PubMed 28111625Derbyshire EJ. Flexitarian Diets and Health: A Review of the Evidence-Based Literature. Front Nutr. 2017 Jan 6;3:55. doi: 10.3389/fnut.2016.00055. eCollection 2016.
- Background: PubMed 27493937Edelman M, Colt M. Nutrient Value of Leaf vs. Seed. Front Chem. 2016 Jul 21;4:32. doi: 10.3389/fchem.2016.00032. eCollection 2016.
- Background: PubMed 27916823Rizzo G, Lagana AS, Rapisarda AM, La Ferrera GM, Buscema M, Rossetti P, Nigro A, Muscia V, Valenti G, Sapia F, Sarpietro G, Zigarelli M, Vitale SG. Vitamin B12 among Vegetarians: Status, Assessment and Supplementation. Nutrients. 2016 Nov 29;8(12):767. doi: 10.3390/nu8120767.
- Individual participant dataSharing planned: No. Confidentiality and Privacy: Information about study subjects will be kept confidential and managed according to the Health Insurance Portability and Accountability Act of 1996 (HIPAA). Source Documents: Source data will include the electronic health record for patient demographics, vitals, and basic laboratory results. Dictated operative notes will be maintained within the EHR as well. Lab results of inflammatory markers will be kept out of the EHR and kept in a secure file on the Cleveland Clinic server. Records Retention: The investigators will retain study essential documents for at least six years after completion of the research and are accessible for inspection by authorized representatives at reasonable times and in a reasonable manner.
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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.
Emanuele Lo Menzo, MD principal investigator
Cleveland Clinic Florida
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dietary modification with introduction of Mankai in people with Bariatric Surgery Candidate and Diet Modification, run by Cleveland Clinic Florida at 1 site in United States.
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 4 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 4 Feb 2021. 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 United States. 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?
Patient's Satiety with Wolffia Globosa (Mankai) shake measured with a QUALITY OF ALIMENTATION QUESTIONNAIRE (time frame: 2 weeks). The study lists 5 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 NCT03999632, which also lists 12 linked publications.
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 4 Feb 2021.