Men With Mild Abdominal ObesityMankaiNCT03020225
Protein Bioavailability of Wolffia Globosa (Mankai); Acute Test Meal Effects
A study testing White cheese, Green peas and Mankai in people with Men With Mild Abdominal Obesity, run by Ben-Gurion University of the Negev at 1 site in Israel.
Trial summary
The investigators aim to test the protein bioavailability of new specific developed strain of duckweed [Wolffia globose, Mankai] , an aquatic plant, which might serve as a protein source and contains all the 9 essential and the 6 conditional amino acids. Read more about this study
- Who is it for?
- Ages 30 years and older, men onlyHealthy volunteers can take part
- Conditions the study is for
- Men With Mild Abdominal Obesity
- What is being tested?
- White cheese, Green peas and Mankai
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteIsrael
- Study dates
- Dec 2016to Jul 2017
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 30 years and older
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- age >30 years; abdominal adiposity (waist circumference: men > 102 cm, women > 88 cm) or dyslipidemia
Who cannot join
- triglycerides>400 mg/dL; serum creatinine>2 mg/dL;
- disturbed liver function;
- pregnant or lactating women;
- presence of active cancer, is receiving or received chemotherapy in the last three years; participation in another trial;
- participants who are treated with Coumadin (warfarin)
Trial locations and contacts
1 site in 1 country.
About this study
The investigators aim to test the protein bioavailability of new specific developed strain of duckweed [Wolffia globose, Mankai] , an aquatic plant, which might serve as a protein source and contains all the 9 essential and the 6 conditional amino acids. The investigators will randomize 36 participants to consume equivalent protein (30gr) content of 3 whole foods items: 1. White cheese (animal protein source, as a reference); 2. Green peas, intact, cooked (plant protein source); 3. Wolffia globosa (Mankai), intact, cooked (plant protein source). The foods will be consumed in the morning, following 12h fasting. The foods will be provided with 250ml mineral water and the blood follow-up frame will be for 3 hours. Primary outcome: Blood amino acid profile.
Read the detailed description
The investigators aim to test the protein bioavailability of new specific developed strain of duckweed [Wolffia globose, Mankai], an aquatic plant, which might serve as a protein source and contains all the 9 essential and the 6 conditional amino acids. "Mankai" [(Generally recognized as safe (GRAS)] is a cultivated strain of Wolffia globosa, which is an aquatic plant, part of the family of plants known commonly as duckweeds. Duckweeds are very simple flowering aquatic plants which float on or just beneath the surface of still or slow-moving bodies of water. There is a long history of the use of Wolffia species, in particular Wolffia Globosa, as food, especially in Southeast Asia: Burma, Laos and northern Thailand, where it has been used as a vegetable for many generations. There are numerous ways of W. globosa consumption and a variety of recipes, using it either as a main ingredient (such as Wolffia crisps or "kaeng pum" - a popular vegetable dish in northeastern Thailand) or incorporating it in other foods (e.g. Wolffia-meat ball, fermented Wolffia-meat sausage, Wolffia rice noodle, Wolffia cookies, Wolffia bread, and various soups and salads). Along with its long history as a food source in Southeast Asia, it is recognized as an edible vegetable for humans in several databases, including the United States Department of Agriculture (USDA 2014) GRIN database and a database dedicated to tropical species. The nutritional composition of Mankai has been determined and found to be high in protein, containing all the essential and conditionally essential amino acids, dietary fibers and several vitamins and minerals. In a recent safety study, which aimed to test the safety of Mankai administration within and 3 times of the amount approved in the GRAS, 4 groups of female SD rats were orally administered for 4 consecutive days a daily dose of Mankai at three dose levels of 1700, 2500 and 3400mg/kg of Mankai, equivalent to 20, 40 and 60 gr/day human dose, respectively. Clinical (e.g body weight, food intake, morbidity/mortality, toxic signs), pathological (post mortem gross pathology examination) and long list of blood biochemical indicators (e.g liver status biomarkers, stress indicators, minerals) did not show any adverse effects. The results indicate that repeated four day Mankai administration did not cause adverse effects. Unexpectedly, high doses even suggested beneficial results with anti-glycemic effects. Mankai was found to have a high digestibility profile (89%) according to Protein digestibility-corrected amino acid score (PDCAAS) Eurofins tests. However, its human nutrient bioavailability has not been examined yet. For the proposed test, Mankai (grown by Hinoman Ltd., Israel) will be provided as a fresh, whole, product.
Methods: 36 men will be randomized to consume the following food items, which will be equivalent to 30gr protein, after 12h night fasting:
- Reference group: animal protein food source: White cheese, intact, plus 250ml mineral water
- Test group 1: plant food source: Green peas, intact, cooked, plus 250ml mineral water
- Test group 2: plant food source: Wolffia globosa (Mankai), intact, cooked, plus 250ml mineral water
The participants will be asked to maintain a stable diet (according to guidelines that will be provided) for 3 days prior to the test meal. Blood samples will be taken at times 0, 30, 90, and 180 minutes.
- Conditions
- Men With Mild Abdominal Obesity
- Being tested
- White cheese, Green peas, Mankai
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
White cheeseDietary supplement
animal protein food source: White cheese (contains 30g protein), intact, plus 250ml mineral water
Green peasDietary supplement
Green peas (contains 30g protein), intact, cooked, plus 250ml mineral water
MankaiDietary supplement
Wolffia globosa (Mankai, contains 30g protein), intact, cooked, plus 250ml mineral water
| Study group | Role | What they receive |
|---|---|---|
| White cheese | Active comparator | Reference group- animal protein food source: White cheese (contains 30g protein), intact, plus 250ml mineral water Receives: Dietary Supplement: White cheese |
| Green peas | Experimental | Plant food source: Green peas (contains 30g protein), intact, cooked, plus 250ml mineral water Receives: Dietary Supplement: Green peas |
| Mankai | Experimental | Plant food source: Wolffia globosa (Mankai, contains 30g protein), intact, cooked, plus 250ml mineral water Receives: Dietary Supplement: Mankai |
What is being measured
The primary outcome is the main question the study is designed to answer.
Amino Acid Profile (Blood Biomarkers)
will be analysed by metabolomic for amino acid profile (trajectory)
Measured: 3 hours
Secondary outcomes (9)
Glycemic Profile
glucose (blood biomarkers)
Measured: 3 hours
Lipid Profile
HDL cholesterol fractions (blood biomarkers)
Measured: 3 hours
Liver Function
ALT (blood biomarkers)
Measured: 3 hours
Minerals
potassium (blood measures)
Measured: 3 hours
Vitamins
B12 (blood measures)
Measured: 3 hours
Glycemic Profile-Insulin
Insulin (blood biomarker)
Measured: 3 hours
Triglycerides
Triglycerides levels- Lipid profile
Measured: 3 hours
Liver Enzymes- ASAT
ASAT - Liver enzymes
Measured: 3 hours
Magnesium
Magnesium levels
Measured: 3 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2017 (estimated)
- Study startDec 2016
- Primary completionFeb 2017
- Study completionJul 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Men With Mild Abdominal ObesityStudies 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
- Masking
- None (open label)
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ben-Gurion University of the Negev
- Sponsor type
- University, hospital or other
- Collaborators
- Harvard School of Public Health (HSPH), University of Leipzig
- Responsible party
- Principal investigator, Iris Shai, Ben-Gurion University of the Negev
- Investigators
- Shai, Principal investigator, Ben-Gurion University of the Negev
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03020225
- Sponsor's protocol ID
- BenGurionU
- Acronym
- Mankai
- Status last verified
- Jan 2022
- First submitted
- 9 Jan 2017
- Last updated
- 5 Apr 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Kaplan A, Zelicha H, Tsaban G, Yaskolka Meir A, Rinott E, Kovsan J, Novack L, Thiery J, Ceglarek U, Burkhardt R, Willenberg A, Tirosh A, Cabantchik I, Stampfer MJ, Shai I. Protein bioavailability of Wolffia globosa duckweed, a novel aquatic plant - A randomized controlled trial. Clin Nutr. 2019 Dec;38(6):2576-2582. doi: 10.1016/j.clnu.2018.12.009. Epub 2018 Dec 11.
PubMed 30591380
Study at a glance
From the registry record, last updated by the sponsor on 5 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Protein Bioavailability of Wolffia Globosa (Mankai); Acute Test Meal Effects
- ClinicalTrials.gov ID
- NCT03020225
- Acronym / sponsor ID
- Mankai / BenGurionU
- Conditions
- Men With Mild Abdominal Obesity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Ben-Gurion University of the NegevUniversity, hospital or other
- Collaborators
- Harvard School of Public Health (HSPH), University of Leipzig
- Study start
- Dec 2016
- Primary completion
- Feb 2017 (actual)
- Study completion
- Jul 2017 (actual)
- First posted
- 13 Jan 2017 (estimated)
- Results
- Posted 5 Apr 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The investigators aim to test the protein bioavailability of new specific developed strain of duckweed [Wolffia globose, Mankai] , an aquatic plant, which might serve as a protein source and contains all the 9 essential and the 6 conditional amino acids. The investigators will randomize 36 participants to consume equivalent protein (30gr) content of 3 whole foods items: 1. White cheese (animal protein source, as a reference); 2. Green peas, intact, cooked (plant protein source); 3. Wolffia globosa (Mankai), intact, cooked (plant protein source). The foods will be consumed in the morning, following 12h fasting. The foods will be provided with 250ml mineral water and the blood follow-up frame will be for 3 hours. Primary outcome: Blood amino acid profile.
Detailed description
The investigators aim to test the protein bioavailability of new specific developed strain of duckweed [Wolffia globose, Mankai], an aquatic plant, which might serve as a protein source and contains all the 9 essential and the 6 conditional amino acids. "Mankai" [(Generally recognized as safe (GRAS)] is a cultivated strain of Wolffia globosa, which is an aquatic plant, part of the family of plants known commonly as duckweeds. Duckweeds are very simple flowering aquatic plants which float on or just beneath the surface of still or slow-moving bodies of water. There is a long history of the use of Wolffia species, in particular Wolffia Globosa, as food, especially in Southeast Asia: Burma, Laos and northern Thailand, where it has been used as a vegetable for many generations. There are numerous ways of W. globosa consumption and a variety of recipes, using it either as a main ingredient (such as Wolffia crisps or "kaeng pum" - a popular vegetable dish in northeastern Thailand) or incorporating it in other foods (e.g. Wolffia-meat ball, fermented Wolffia-meat sausage, Wolffia rice noodle, Wolffia cookies, Wolffia bread, and various soups and salads). Along with its long history as a food source in Southeast Asia, it is recognized as an edible vegetable for humans in several databases, including the United States Department of Agriculture (USDA 2014) GRIN database and a database dedicated to tropical species. The nutritional composition of Mankai has been determined and found to be high in protein, containing all the essential and conditionally essential amino acids, dietary fibers and several vitamins and minerals. In a recent safety study, which aimed to test the safety of Mankai administration within and 3 times of the amount approved in the GRAS, 4 groups of female SD rats were orally administered for 4 consecutive days a daily dose of Mankai at three dose levels of 1700, 2500 and 3400mg/kg of Mankai, equivalent to 20, 40 and 60 gr/day human dose, respectively. Clinical (e.g body weight, food intake, morbidity/mortality, toxic signs), pathological (post mortem gross pathology examination) and long list of blood biochemical indicators (e.g liver status biomarkers, stress indicators, minerals) did not show any adverse effects. The results indicate that repeated four day Mankai administration did not cause adverse effects. Unexpectedly, high doses even suggested beneficial results with anti-glycemic effects. Mankai was found to have a high digestibility profile (89%) according to Protein digestibility-corrected amino acid score (PDCAAS) Eurofins tests. However, its human nutrient bioavailability has not been examined yet. For the proposed test, Mankai (grown by Hinoman Ltd., Israel) will be provided as a fresh, whole, product.
Methods: 36 men will be randomized to consume the following food items, which will be equivalent to 30gr protein, after 12h night fasting:
- Reference group: animal protein food source: White cheese, intact, plus 250ml mineral water
- Test group 1: plant food source: Green peas, intact, cooked, plus 250ml mineral water
- Test group 2: plant food source: Wolffia globosa (Mankai), intact, cooked, plus 250ml mineral water
The participants will be asked to maintain a stable diet (according to guidelines that will be provided) for 3 days prior to the test meal. Blood samples will be taken at times 0, 30, 90, and 180 minutes.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| White cheese | Active comparator | Dietary Supplement: White cheeseReference group- animal protein food source: White cheese (contains 30g protein), intact, plus 250ml mineral water |
| Green peas | Experimental | Dietary Supplement: Green peasPlant food source: Green peas (contains 30g protein), intact, cooked, plus 250ml mineral water |
| Mankai | Experimental | Dietary Supplement: MankaiPlant food source: Wolffia globosa (Mankai, contains 30g protein), intact, cooked, plus 250ml mineral water |
Who may qualify
- Ages
- 30 years and older
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- age >30 years; abdominal adiposity (waist circumference: men > 102 cm, women > 88 cm) or dyslipidemia
Key exclusion criteria (5 listed)
- triglycerides>400 mg/dL; serum creatinine>2 mg/dL;
- disturbed liver function;
- pregnant or lactating women;
- presence of active cancer, is receiving or received chemotherapy in the last three years; participation in another trial;
- participants who are treated with Coumadin (warfarin)
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 |
|---|---|---|
| White cheeseanimal protein food source: White cheese (contains 30g protein), intact, plus 250ml mineral water | Dietary supplement | White cheese |
| Green peasGreen peas (contains 30g protein), intact, cooked, plus 250ml mineral water | Dietary supplement | Green peas |
| MankaiWolffia globosa (Mankai, contains 30g protein), intact, cooked, plus 250ml mineral water | Dietary supplement | Mankai |
Primary outcome
Amino Acid Profile (Blood Biomarkers)
Time frame: 3 hours
will be analysed by metabolomic for amino acid profile (trajectory)
9 secondary outcomes
Glycemic Profile
Time frame: 3 hours
Lipid Profile
Time frame: 3 hours
Liver Function
Time frame: 3 hours
Minerals
Time frame: 3 hours
Vitamins
Time frame: 3 hours
Glycemic Profile-Insulin
Time frame: 3 hours
Triglycerides
Time frame: 3 hours
Liver Enzymes- ASAT
Time frame: 3 hours
Magnesium
Time frame: 3 hours
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Apr 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 30591380Kaplan A, Zelicha H, Tsaban G, Yaskolka Meir A, Rinott E, Kovsan J, Novack L, Thiery J, Ceglarek U, Burkhardt R, Willenberg A, Tirosh A, Cabantchik I, Stampfer MJ, Shai I. Protein bioavailability of Wolffia globosa duckweed, a novel aquatic plant - A randomized controlled trial. Clin Nutr. 2019 Dec;38(6):2576-2582. doi: 10.1016/j.clnu.2018.12.009. Epub 2018 Dec 11.
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.
Shai principal investigator
Ben-Gurion University of the Negev
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing White cheese, Green peas and Mankai in people with Men With Mild Abdominal Obesity, run by Ben-Gurion University of the Negev at 1 site in Israel.
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 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 5 Apr 2022. 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 Israel. 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?
Yes. Results are posted in the registry (first posted 5 Apr 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Amino Acid Profile (Blood Biomarkers) (time frame: 3 hours). 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 NCT03020225, 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 5 Apr 2022.