Trial Outcomes & Findings for Protein Bioavailability of Wolffia Globosa (Mankai); Acute Test Meal Effects (NCT NCT03020225)

Results Overview

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

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

36 participants

Primary outcome timeframe

3 hours

Results posted on

2022-04-05

Participant Flow

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

Participant milestones

Participant milestones
Measure	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	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	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
Overall Study STARTED	12	11	13
Overall Study COMPLETED	12	11	13
Overall Study NOT COMPLETED	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	White Cheese n=12 Participants 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	Green Peas n=11 Participants 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	Mankai n=13 Participants 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	Total n=36 Participants Total of all reporting groups
Age, Continuous	48 years STANDARD_DEVIATION 8.8 • n=12 Participants	49.5 years STANDARD_DEVIATION 12.1 • n=11 Participants	48.9 years STANDARD_DEVIATION 11 • n=13 Participants	48.8 years STANDARD_DEVIATION 10.4 • n=36 Participants
Sex/Gender, Customized number of man (%)	12 Participants n=12 Participants	11 Participants n=11 Participants	13 Participants n=13 Participants	36 Participants n=36 Participants
Race and Ethnicity Not Collected	—	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment Israel	12 Participants n=12 Participants	11 Participants n=11 Participants	13 Participants n=13 Participants	36 Participants n=36 Participants
Histidine (EAA)	31.1 µmol/L STANDARD_DEVIATION 4.1 • n=12 Participants	31.3 µmol/L STANDARD_DEVIATION 4.1 • n=11 Participants	30 µmol/L STANDARD_DEVIATION 2.9 • n=13 Participants	30.7 µmol/L STANDARD_DEVIATION 3.7 • n=36 Participants
Tryptophan (EAA)	14.2 µmol/L STANDARD_DEVIATION 2.9 • n=12 Participants	13.8 µmol/L STANDARD_DEVIATION 3.5 • n=11 Participants	12.4 µmol/L STANDARD_DEVIATION 2.5 • n=13 Participants	13.4 µmol/L STANDARD_DEVIATION 3 • n=36 Participants
Phenylalanine (EAA)	67.4 µmol/L STANDARD_DEVIATION 13.5 • n=12 Participants	60.3 µmol/L STANDARD_DEVIATION 10.2 • n=11 Participants	63.4 µmol/L STANDARD_DEVIATION 8.5 • n=13 Participants	63.8 µmol/L STANDARD_DEVIATION 10.9 • n=36 Participants
Methionine (EAA)	30.3 µmol/L STANDARD_DEVIATION 7.4 • n=12 Participants	25.6 µmol/L STANDARD_DEVIATION 4.2 • n=11 Participants	28.2 µmol/L STANDARD_DEVIATION 6.1 • n=13 Participants	28.1 µmol/L STANDARD_DEVIATION 6.2 • n=36 Participants
Threonine (EAA)	31.2 µmol/L STANDARD_DEVIATION 6.7 • n=12 Participants	29.9 µmol/L STANDARD_DEVIATION 6.8 • n=11 Participants	30.2 µmol/L STANDARD_DEVIATION 5.7 • n=13 Participants	30.5 µmol/L STANDARD_DEVIATION 6.2 • n=36 Participants
Lysine (EAA)	81 µmol/L STANDARD_DEVIATION 24.9 • n=12 Participants	73.2 µmol/L STANDARD_DEVIATION 22.2 • n=11 Participants	72.7 µmol/L STANDARD_DEVIATION 19.5 • n=13 Participants	75.6 µmol/L STANDARD_DEVIATION 21.9 • n=36 Participants
Valine (EAA)	187.1 µmol/L STANDARD_DEVIATION 31.2 • n=12 Participants	179.3 µmol/L STANDARD_DEVIATION 36.3 • n=11 Participants	184.4 µmol/L STANDARD_DEVIATION 25 • n=13 Participants	183.7 µmol/L STANDARD_DEVIATION 30.2 • n=36 Participants
Isoleucine/leucine (EAA)	141.8 µmol/L STANDARD_DEVIATION 27.2 • n=12 Participants	129 µmol/L STANDARD_DEVIATION 26.6 • n=11 Participants	139.7 µmol/L STANDARD_DEVIATION 19.6 • n=13 Participants	137.1 µmol/L STANDARD_DEVIATION 24.5 • n=36 Participants

PRIMARY outcome

Timeframe: 3 hours

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

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

Outcome measures

Outcome measures
Measure	White Cheese n=12 Participants Essential amino acids (mmol/L)	Green Peas n=11 Participants Essential amino acids	Mankai n=13 Participants Essential amino acids
Amino Acid Profile (Blood Biomarkers)	31.1 mmol/L Standard Deviation 4.1	31.1 mmol/L Standard Deviation 4.1	30 mmol/L Standard Deviation 2.9

SECONDARY outcome

Timeframe: 3 hours

Population: glucose

glucose (blood biomarkers)

Outcome measures

Outcome measures
Measure	White Cheese n=12 Participants Essential amino acids (mmol/L)	Green Peas n=11 Participants Essential amino acids	Mankai n=13 Participants Essential amino acids
Glycemic Profile	97.5 mg/dL Standard Deviation 13.4	96 mg/dL Standard Deviation 9.2	96.7 mg/dL Standard Deviation 9.4

SECONDARY outcome

Timeframe: 3 hours

Population: cholesterol fractions

HDL cholesterol fractions (blood biomarkers)

Outcome measures

Outcome measures
Measure	White Cheese n=12 Participants Essential amino acids (mmol/L)	Green Peas n=11 Participants Essential amino acids	Mankai n=13 Participants Essential amino acids
Lipid Profile	45.3 mg/dL Standard Deviation 9.9	41.9 mg/dL Standard Deviation 9.3	44.4 mg/dL Standard Deviation 7.8

SECONDARY outcome

Timeframe: 3 hours

Population: ALT

ALT (blood biomarkers)

Outcome measures

Outcome measures
Measure	White Cheese n=12 Participants Essential amino acids (mmol/L)	Green Peas n=11 Participants Essential amino acids	Mankai n=13 Participants Essential amino acids
Liver Function	43.2 U/l Standard Deviation 13.2	42.3 U/l Standard Deviation 21.1	46 U/l Standard Deviation 19.5

SECONDARY outcome

Timeframe: 3 hours

Population: potassium

potassium (blood measures)

Outcome measures

Outcome measures
Measure	White Cheese n=12 Participants Essential amino acids (mmol/L)	Green Peas n=11 Participants Essential amino acids	Mankai n=13 Participants Essential amino acids
Minerals	4.5 mmol/L Standard Deviation 0.2	4.7 mmol/L Standard Deviation 0.3	4.5 mmol/L Standard Deviation 0.2

SECONDARY outcome

Timeframe: 3 hours

Population: B12

B12 (blood measures)

Outcome measures

Outcome measures
Measure	White Cheese n=12 Participants Essential amino acids (mmol/L)	Green Peas n=11 Participants Essential amino acids	Mankai n=13 Participants Essential amino acids
Vitamins	371.1 pg/mL Standard Deviation 146.4	473 pg/mL Standard Deviation 144.1	423 pg/mL Standard Deviation 220.4

SECONDARY outcome

Timeframe: 3 hours

Population: Insulin

Insulin (blood biomarker)

Outcome measures

Outcome measures
Measure	White Cheese n=12 Participants Essential amino acids (mmol/L)	Green Peas n=11 Participants Essential amino acids	Mankai n=13 Participants Essential amino acids
Glycemic Profile-Insulin	97.5 mg/dL Standard Deviation 13.4	96 mg/dL Standard Deviation 9.2	96.7 mg/dL Standard Deviation 9.4

SECONDARY outcome

Timeframe: 3 hours

Population: Triglycerides

Triglycerides levels- Lipid profile

Outcome measures

Outcome measures
Measure	White Cheese n=12 Participants Essential amino acids (mmol/L)	Green Peas n=11 Participants Essential amino acids	Mankai n=13 Participants Essential amino acids
Triglycerides	172.2 mg/dl Standard Deviation 77	198 mg/dl Standard Deviation 111.7	207.9 mg/dl Standard Deviation 83

SECONDARY outcome

Timeframe: 3 hours

Population: ASAT

ASAT - Liver enzymes

Outcome measures

Outcome measures
Measure	White Cheese n=12 Participants Essential amino acids (mmol/L)	Green Peas n=11 Participants Essential amino acids	Mankai n=13 Participants Essential amino acids
Liver Enzymes- ASAT	0.53 μKat/L Standard Deviation 0.09	0.49 μKat/L Standard Deviation 0.09	0.51 μKat/L Standard Deviation 0.18

SECONDARY outcome

Timeframe: 3 hours

Population: Magnesium levels

Magnesium levels

Outcome measures

Outcome measures
Measure	White Cheese n=12 Participants Essential amino acids (mmol/L)	Green Peas n=11 Participants Essential amino acids	Mankai n=13 Participants Essential amino acids
Magnesium	0.87 mmol/L Standard Deviation 0.072	0.95 mmol/L Standard Deviation 0.28	0.91 mmol/L Standard Deviation 0.054

Adverse Events

White Cheese

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Green Peas

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Mankai

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Prof. Iris Shai

BGU

Phone: +972 52-579-3040

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place