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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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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.

Israel1 site
  • nuclear research center Negev

    Dimona

Other trials in Israel

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:

  1. Reference group: animal protein food source: White cheese, intact, plus 250ml mineral water
  2. Test group 1: plant food source: Green peas, intact, cooked, plus 250ml mineral water
  3. 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.

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 groups in NCT03020225
Study groupRoleWhat they receive
White cheeseActive comparatorReference group- animal protein food source: White cheese (contains 30g protein), intact, plus 250ml mineral water
Receives: Dietary Supplement: White cheese
Green peasExperimentalPlant food source: Green peas (contains 30g protein), intact, cooked, plus 250ml mineral water
Receives: Dietary Supplement: Green peas
MankaiExperimentalPlant 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.

  1. Amino Acid Profile (Blood Biomarkers)

    will be analysed by metabolomic for amino acid profile (trajectory)

    Measured: 3 hours

Secondary outcomes (9)
  1. Glycemic Profile

    glucose (blood biomarkers)

    Measured: 3 hours

  2. Lipid Profile

    HDL cholesterol fractions (blood biomarkers)

    Measured: 3 hours

  3. Liver Function

    ALT (blood biomarkers)

    Measured: 3 hours

  4. Minerals

    potassium (blood measures)

    Measured: 3 hours

  5. Vitamins

    B12 (blood measures)

    Measured: 3 hours

  6. Glycemic Profile-Insulin

    Insulin (blood biomarker)

    Measured: 3 hours

  7. Triglycerides

    Triglycerides levels- Lipid profile

    Measured: 3 hours

  8. Liver Enzymes- ASAT

    ASAT - Liver enzymes

    Measured: 3 hours

  9. 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.

  1. First posted13 Jan 2017 (estimated)
  2. Study startDec 2016
  3. Primary completionFeb 2017
  4. Study completionJul 2017

Resources

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)
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
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

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.

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