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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03020225
Acronym
Mankai
Enrollment
36
Registered
2017-01-13
Start date
2016-12-31
Completion date
2017-07-31
Last updated
2022-04-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Men With Mild Abdominal Obesity

Brief 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.

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.

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

Sponsors

Harvard School of Public Health (HSPH)
CollaboratorOTHER
University of Leipzig
CollaboratorOTHER
Ben-Gurion University of the Negev
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE

Eligibility

Sex/Gender
MALE
Age
30 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

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

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)

Design outcomes

Primary

MeasureTime frameDescription
Amino Acid Profile (Blood Biomarkers)3 hourswill be analysed by metabolomic for amino acid profile (trajectory)

Secondary

MeasureTime frameDescription
Lipid Profile3 hoursHDL cholesterol fractions (blood biomarkers)
Liver Function3 hoursALT (blood biomarkers)
Minerals3 hourspotassium (blood measures)
Vitamins3 hoursB12 (blood measures)
Glycemic Profile3 hoursglucose (blood biomarkers)
Triglycerides3 hoursTriglycerides levels- Lipid profile
Liver Enzymes- ASAT3 hoursASAT - Liver enzymes
Magnesium3 hoursMagnesium levels
Glycemic Profile-Insulin3 hoursInsulin (blood biomarker)

Countries

Israel

Participant flow

Recruitment details

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

Pre-assignment details

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

Participants by arm

ArmCount
White Cheese
Reference group- animal protein food source: White cheese (contains 30g protein), intact, plus 250ml mineral water White cheese: animal protein food source: White cheese (contains 30g protein), intact, plus 250ml mineral water
12
Green Peas
Plant food source: Green peas (contains 30g protein), intact, cooked, plus 250ml mineral water Green peas: Green peas (contains 30g protein), intact, cooked, plus 250ml mineral water
11
Mankai
Plant food source: Wolffia globosa (Mankai, contains 30g protein), intact, cooked, plus 250ml mineral water Mankai: Wolffia globosa (Mankai, contains 30g protein), intact, cooked, plus 250ml mineral water
13
Total36

Baseline characteristics

CharacteristicMankaiTotalWhite CheeseGreen Peas
Age, Continuous48.9 years
STANDARD_DEVIATION 11
48.8 years
STANDARD_DEVIATION 10.4
48 years
STANDARD_DEVIATION 8.8
49.5 years
STANDARD_DEVIATION 12.1
Histidine (EAA)30 µmol/L
STANDARD_DEVIATION 2.9
30.7 µmol/L
STANDARD_DEVIATION 3.7
31.1 µmol/L
STANDARD_DEVIATION 4.1
31.3 µmol/L
STANDARD_DEVIATION 4.1
Isoleucine/leucine (EAA)139.7 µmol/L
STANDARD_DEVIATION 19.6
137.1 µmol/L
STANDARD_DEVIATION 24.5
141.8 µmol/L
STANDARD_DEVIATION 27.2
129 µmol/L
STANDARD_DEVIATION 26.6
Lysine (EAA)72.7 µmol/L
STANDARD_DEVIATION 19.5
75.6 µmol/L
STANDARD_DEVIATION 21.9
81 µmol/L
STANDARD_DEVIATION 24.9
73.2 µmol/L
STANDARD_DEVIATION 22.2
Methionine (EAA)28.2 µmol/L
STANDARD_DEVIATION 6.1
28.1 µmol/L
STANDARD_DEVIATION 6.2
30.3 µmol/L
STANDARD_DEVIATION 7.4
25.6 µmol/L
STANDARD_DEVIATION 4.2
Phenylalanine (EAA)63.4 µmol/L
STANDARD_DEVIATION 8.5
63.8 µmol/L
STANDARD_DEVIATION 10.9
67.4 µmol/L
STANDARD_DEVIATION 13.5
60.3 µmol/L
STANDARD_DEVIATION 10.2
Race and Ethnicity Not Collected0 Participants
Region of Enrollment
Israel
13 Participants36 Participants12 Participants11 Participants
Sex/Gender, Customized
number of man (%)
13 Participants36 Participants12 Participants11 Participants
Threonine (EAA)30.2 µmol/L
STANDARD_DEVIATION 5.7
30.5 µmol/L
STANDARD_DEVIATION 6.2
31.2 µmol/L
STANDARD_DEVIATION 6.7
29.9 µmol/L
STANDARD_DEVIATION 6.8
Tryptophan (EAA)12.4 µmol/L
STANDARD_DEVIATION 2.5
13.4 µmol/L
STANDARD_DEVIATION 3
14.2 µmol/L
STANDARD_DEVIATION 2.9
13.8 µmol/L
STANDARD_DEVIATION 3.5
Valine (EAA)184.4 µmol/L
STANDARD_DEVIATION 25
183.7 µmol/L
STANDARD_DEVIATION 30.2
187.1 µmol/L
STANDARD_DEVIATION 31.2
179.3 µmol/L
STANDARD_DEVIATION 36.3

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
EG002
affected / at risk
deaths
Total, all-cause mortality
0 / 120 / 110 / 13
other
Total, other adverse events
0 / 120 / 110 / 13
serious
Total, serious adverse events
0 / 120 / 110 / 13

Outcome results

Primary

Amino Acid Profile (Blood Biomarkers)

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

Time frame: 3 hours

Population: Essential amino acids (mmol/L) for the 3 groups

ArmMeasureValue (MEAN)Dispersion
White CheeseAmino Acid Profile (Blood Biomarkers)31.1 mmol/LStandard Deviation 4.1
Green PeasAmino Acid Profile (Blood Biomarkers)31.1 mmol/LStandard Deviation 4.1
MankaiAmino Acid Profile (Blood Biomarkers)30 mmol/LStandard Deviation 2.9
Secondary

Glycemic Profile

glucose (blood biomarkers)

Time frame: 3 hours

Population: glucose

ArmMeasureValue (MEAN)Dispersion
White CheeseGlycemic Profile97.5 mg/dLStandard Deviation 13.4
Green PeasGlycemic Profile96 mg/dLStandard Deviation 9.2
MankaiGlycemic Profile96.7 mg/dLStandard Deviation 9.4
Secondary

Glycemic Profile-Insulin

Insulin (blood biomarker)

Time frame: 3 hours

Population: Insulin

ArmMeasureValue (MEAN)Dispersion
White CheeseGlycemic Profile-Insulin97.5 mg/dLStandard Deviation 13.4
Green PeasGlycemic Profile-Insulin96 mg/dLStandard Deviation 9.2
MankaiGlycemic Profile-Insulin96.7 mg/dLStandard Deviation 9.4
Secondary

Lipid Profile

HDL cholesterol fractions (blood biomarkers)

Time frame: 3 hours

Population: cholesterol fractions

ArmMeasureValue (MEAN)Dispersion
White CheeseLipid Profile45.3 mg/dLStandard Deviation 9.9
Green PeasLipid Profile41.9 mg/dLStandard Deviation 9.3
MankaiLipid Profile44.4 mg/dLStandard Deviation 7.8
Secondary

Liver Enzymes- ASAT

ASAT - Liver enzymes

Time frame: 3 hours

Population: ASAT

ArmMeasureValue (MEAN)Dispersion
White CheeseLiver Enzymes- ASAT0.53 μKat/LStandard Deviation 0.09
Green PeasLiver Enzymes- ASAT0.49 μKat/LStandard Deviation 0.09
MankaiLiver Enzymes- ASAT0.51 μKat/LStandard Deviation 0.18
Secondary

Liver Function

ALT (blood biomarkers)

Time frame: 3 hours

Population: ALT

ArmMeasureValue (MEAN)Dispersion
White CheeseLiver Function43.2 U/lStandard Deviation 13.2
Green PeasLiver Function42.3 U/lStandard Deviation 21.1
MankaiLiver Function46 U/lStandard Deviation 19.5
Secondary

Magnesium

Magnesium levels

Time frame: 3 hours

Population: Magnesium levels

ArmMeasureValue (MEAN)Dispersion
White CheeseMagnesium0.87 mmol/LStandard Deviation 0.072
Green PeasMagnesium0.95 mmol/LStandard Deviation 0.28
MankaiMagnesium0.91 mmol/LStandard Deviation 0.054
Secondary

Minerals

potassium (blood measures)

Time frame: 3 hours

Population: potassium

ArmMeasureValue (MEAN)Dispersion
White CheeseMinerals4.5 mmol/LStandard Deviation 0.2
Green PeasMinerals4.7 mmol/LStandard Deviation 0.3
MankaiMinerals4.5 mmol/LStandard Deviation 0.2
Secondary

Triglycerides

Triglycerides levels- Lipid profile

Time frame: 3 hours

Population: Triglycerides

ArmMeasureValue (MEAN)Dispersion
White CheeseTriglycerides172.2 mg/dlStandard Deviation 77
Green PeasTriglycerides198 mg/dlStandard Deviation 111.7
MankaiTriglycerides207.9 mg/dlStandard Deviation 83
Secondary

Vitamins

B12 (blood measures)

Time frame: 3 hours

Population: B12

ArmMeasureValue (MEAN)Dispersion
White CheeseVitamins371.1 pg/mLStandard Deviation 146.4
Green PeasVitamins473 pg/mLStandard Deviation 144.1
MankaiVitamins423 pg/mLStandard Deviation 220.4

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026