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CompletedNCT03020225MankaiUpdated Apr 5, 2022Results posted

Protein Bioavailability of Wolffia Globosa (Mankai); Acute Test Meal Effects

An interventional study of White cheese and Green peas in Men With Mild Abdominal Obesity, sponsored by Ben-Gurion University of the Negev. Completed at 1 site in Israel. Open to male participants aged 30 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-04-05.

Sponsored by Ben-Gurion University of the Negev · Not applicable, Interventional, and Other

Phase
Not applicable
Study type
Interventional
Enrollment
36
Allocation
Randomized
Ages
30 Years and older
Sex
Male
01

Study 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. 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.

02

Conditions studied

  • Men With Mild Abdominal Obesity

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03

In context

Obesity, Abdominal

274 studies on the registry are indexed under Obesity, Abdominal; 44 are open to participants now.

This study's enrollment of 36 is below the median of 60 across 216 interventional studies indexed under Obesity, Abdominal.

Browse Obesity, Abdominal studies →

Lead sponsor

Ben-Gurion University of the Negev is the lead sponsor of 17 studies on the registry; 4 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
30 Years and older
Sexes eligible
Male
Accepts healthy volunteers
Yes

Inclusion criteria

  • age >30 years; abdominal adiposity (waist circumference: men > 102 cm, women > 88 cm) or dyslipidemia

Exclusion criteria

Exclusion Criteria:

  • 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)
05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
36 participants (actual)

Study arms

  • Active comparator
    White cheese

    Reference group- animal protein food source: White cheese (contains 30g protein), intact, plus 250ml mineral water

    Dietary Supplement: White cheese

  • Experimental
    Green peas

    Plant food source: Green peas (contains 30g protein), intact, cooked, plus 250ml mineral water

    Dietary Supplement: Green peas

  • Experimental
    Mankai

    Plant food source: Wolffia globosa (Mankai, contains 30g protein), intact, cooked, plus 250ml mineral water

    Dietary Supplement: Mankai

Interventions

  • Dietary supplementWhite cheese

    animal protein food source: White cheese (contains 30g protein), intact, plus 250ml mineral water

  • Dietary supplementGreen peas

    Green peas (contains 30g protein), intact, cooked, plus 250ml mineral water

  • Dietary supplementMankai

    Wolffia globosa (Mankai, contains 30g protein), intact, cooked, plus 250ml mineral water

06

What researchers measure

Primary outcomes

  1. Amino Acid Profile (Blood Biomarkers)

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

    Time frame: 3 hours

Secondary outcomes

  1. Glycemic Profile

    glucose (blood biomarkers)

    Time frame: 3 hours

  2. Lipid Profile

    HDL cholesterol fractions (blood biomarkers)

    Time frame: 3 hours

  3. Liver Function

    ALT (blood biomarkers)

    Time frame: 3 hours

  4. Minerals

    potassium (blood measures)

    Time frame: 3 hours

  5. Vitamins

    B12 (blood measures)

    Time frame: 3 hours

  6. Glycemic Profile-Insulin

    Insulin (blood biomarker)

    Time frame: 3 hours

  7. Triglycerides

    Triglycerides levels- Lipid profile

    Time frame: 3 hours

  8. Liver Enzymes- ASAT

    ASAT - Liver enzymes

    Time frame: 3 hours

  9. Magnesium

    Magnesium levels

    Time frame: 3 hours

07

Results

Posted Apr 5, 2022

Participant flow

https://www.ncbi.nlm.nih.gov/pubmed/30591380

Participant flow — Overall Study
MilestoneWhite CheeseGreen PeasMankai
Started121113
Completed121113
Not completed000

Outcome measures

PrimaryAmino Acid Profile (Blood Biomarkers)

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

Time frame:
3 hours
Reported as:
Mean · mmol/L
Amino Acid Profile (Blood Biomarkers)
mmol/LWhite CheeseGreen PeasMankai
Amino Acid Profile (Blood Biomarkers)31.1 ± 4.131.1 ± 4.130 ± 2.9
SecondaryGlycemic Profile

glucose (blood biomarkers)

Time frame:
3 hours
Reported as:
Mean · mg/dL
Glycemic Profile
mg/dLWhite CheeseGreen PeasMankai
Glycemic Profile97.5 ± 13.496 ± 9.296.7 ± 9.4
SecondaryLipid Profile

HDL cholesterol fractions (blood biomarkers)

Time frame:
3 hours
Reported as:
Mean · mg/dL
Lipid Profile
mg/dLWhite CheeseGreen PeasMankai
Lipid Profile45.3 ± 9.941.9 ± 9.344.4 ± 7.8
SecondaryLiver Function

ALT (blood biomarkers)

Time frame:
3 hours
Reported as:
Mean · U/l
Liver Function
U/lSoft CheeseGreen PeasMankai
Liver Function43.2 ± 13.242.3 ± 21.146 ± 19.5
SecondaryMinerals

potassium (blood measures)

Time frame:
3 hours
Reported as:
Mean · mmol/L
Minerals
mmol/LWhite CheeseGreen PeasMankai
Minerals4.5 ± 0.24.7 ± 0.34.5 ± 0.2
SecondaryVitamins

B12 (blood measures)

Time frame:
3 hours
Reported as:
Mean · pg/mL
Vitamins
pg/mLWhite CheeseGreen PeasMankai
Vitamins371.1 ± 146.4473 ± 144.1423 ± 220.4
SecondaryGlycemic Profile-Insulin

Insulin (blood biomarker)

Time frame:
3 hours
Reported as:
Mean · mg/dL
Glycemic Profile-Insulin
mg/dLWhite CheeseGreen PeasMankai
Glycemic Profile-Insulin97.5 ± 13.496 ± 9.296.7 ± 9.4
SecondaryTriglycerides

Triglycerides levels- Lipid profile

Time frame:
3 hours
Reported as:
Mean · mg/dl
Triglycerides
mg/dlWhite CheeseGreen PeasMankai
Triglycerides172.2 ± 77198 ± 111.7207.9 ± 83
SecondaryLiver Enzymes- ASAT

ASAT - Liver enzymes

Time frame:
3 hours
Reported as:
Mean · μKat/L
Liver Enzymes- ASAT
μKat/LSoft CheeseGreen PeasMankai
Liver Enzymes- ASAT0.53 ± 0.090.49 ± 0.090.51 ± 0.18
SecondaryMagnesium

Magnesium levels

Time frame:
3 hours
Reported as:
Mean · mmol/L
Magnesium
mmol/LWhite CheeseGreen PeasMankai
Magnesium0.87 ± 0.0720.95 ± 0.280.91 ± 0.054

Adverse events

Collected over 3 hours. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
White Cheese0/12 (0%)0/12 (0%)0/12 (0%)
Green Peas0/11 (0%)0/11 (0%)0/11 (0%)
Mankai0/13 (0%)0/13 (0%)0/13 (0%)

Baseline characteristics

https://www.ncbi.nlm.nih.gov/pubmed/30591380

Age, Continuous
Age, Continuous(years)White CheeseGreen PeasMankaiTotal
Mean48 ± 8.849.5 ± 12.148.9 ± 1148.8 ± 10.4
Sex/Gender, Customized
Sex/Gender, Customized(Participants)White CheeseGreen PeasMankaiTotal
number of man (%)12111336
Race and Ethnicity Not Collected
Race and Ethnicity Not Collected(Participants)White CheeseGreen PeasMankaiTotal
Count of participants———0
Region of Enrollment
Region of Enrollment(Participants)White CheeseGreen PeasMankaiTotal
Israel12111336
Histidine (EAA)
Histidine (EAA)(µmol/L)White CheeseGreen PeasMankaiTotal
Mean31.1 ± 4.131.3 ± 4.130 ± 2.930.7 ± 3.7
Tryptophan (EAA)
Tryptophan (EAA)(µmol/L)White CheeseGreen PeasMankaiTotal
Mean14.2 ± 2.913.8 ± 3.512.4 ± 2.513.4 ± 3
Phenylalanine (EAA)
Phenylalanine (EAA)(µmol/L)White CheeseGreen PeasMankaiTotal
Mean67.4 ± 13.560.3 ± 10.263.4 ± 8.563.8 ± 10.9
Methionine (EAA)
Methionine (EAA)(µmol/L)White CheeseGreen PeasMankaiTotal
Mean30.3 ± 7.425.6 ± 4.228.2 ± 6.128.1 ± 6.2

4 further baseline measures are reported on the registry.

08

Study locations

1 site
  • nuclear research center Negev
    Dimona, Israel
09

References and documents

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 documents

  • Protocol and statistical analysis plan · Jan 9, 2017

Documents are hosted by the registry — open the source record to download them.

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 5, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT03020225
Lead sponsor
Ben-Gurion University of the Negev
Collaborators
Harvard School of Public Health (HSPH), University of Leipzig
Responsible party
Iris Shai (Principle investigator, Ben-Gurion University of the Negev) — Principal investigator
First posted
Jan 13, 2017
Start date
Dec 2016
Primary completion
Feb 2017
Completion
Jul 2017
Results posted
Apr 5, 2022
Last update
Apr 5, 2022

Study contacts

Shai
principal investigator · Ben-Gurion University of the Negev

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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