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

• Sponsor: Ben-Gurion University of the Negev (Other)
• Overall Status: Completed
• CT.gov ID: NCT03020225
• Collaborator: Harvard School of Public Health (HSPH) (Other), University of Leipzig (Other)
• Enrollment: 36
• Location: 1
• Arms: 3
• Duration (Months): 7
• Patients Per Site Per Month: 5.2

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Men With Mild Abdominal Obesity	Dietary Supplement: White cheese; Dietary Supplement: Green peas; Dietary Supplement: Mankai	N/A

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 36 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Other
• Official Title: Protein Bioavailability of Wolffia Globosa (Mankai); Acute Test Meal Effects
• Study Start Date: Dec 1, 2016
• Actual Primary Completion Date: Feb 1, 2017
• Actual Study Completion Date: Jul 1, 2017

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: White cheese Reference group- animal protein food source: White cheese (contains 30g protein), intact, plus 250ml mineral water	Dietary Supplement: White cheese; animal protein food source: White cheese (contains 30g protein), intact, plus 250ml mineral water
Experimental: Green peas Plant food source: Green peas (contains 30g protein), intact, cooked, plus 250ml mineral water	Dietary Supplement: Green peas; Green peas (contains 30g protein), intact, cooked, plus 250ml mineral water
Experimental: Mankai Plant food source: Wolffia globosa (Mankai, contains 30g protein), intact, cooked, plus 250ml mineral water	Dietary Supplement: Mankai; Wolffia globosa (Mankai, contains 30g protein), intact, cooked, plus 250ml mineral water

Outcome Measures

Primary Outcome Measures

1. Amino Acid Profile (Blood Biomarkers) [3 hours]

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

Secondary Outcome Measures

1. Glycemic Profile [3 hours]

   glucose (blood biomarkers)

2. Lipid Profile [3 hours]

   HDL cholesterol fractions (blood biomarkers)

3. Liver Function [3 hours]

   ALT (blood biomarkers)

4. Minerals [3 hours]

   potassium (blood measures)

5. Vitamins [3 hours]

   B12 (blood measures)

6. Glycemic Profile-Insulin [3 hours]

   Insulin (blood biomarker)

7. Triglycerides [3 hours]

   Triglycerides levels- Lipid profile

8. Liver Enzymes- ASAT [3 hours]

   ASAT - Liver enzymes

9. Magnesium [3 hours]

   Magnesium levels

Eligibility Criteria

Criteria

• Ages Eligible for Study: 30 Years and Older
• Sexes Eligible for Study: Male
• Accepts 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)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	nuclear research center Negev	Dimona		Israel

Sponsors and Collaborators

• Ben-Gurion University of the Negev
• Harvard School of Public Health (HSPH)
• University of Leipzig

Investigators

• Principal Investigator: Shai, Ben-Gurion University of the Negev

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Jan 9, 2017

More Information

Publications

None provided.

• Responsible Party: Iris Shai, Principle investigator, Ben-Gurion University of the Negev
• ClinicalTrials.gov Identifier: NCT03020225
• Other Study ID Numbers: BenGurionU
• First Posted: Jan 13, 2017
• Last Update Posted: Apr 5, 2022
• Last Verified: Jan 1, 2022

• Additional relevant MeSH terms: Obesity, Abdominal

Study Results

Participant Flow

Recruitment Details	https://www.ncbi.nlm.nih.gov/pubmed/30591380
Pre-assignment Detail	https://www.ncbi.nlm.nih.gov/pubmed/30591380

Arm/Group Title	White Cheese	Green Peas	Mankai
Arm/Group Description	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	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	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
Period Title: Overall Study
STARTED	12	11	13
COMPLETED	12	11	13
NOT COMPLETED	0	0	0

Baseline Characteristics

Arm/Group Title	White Cheese	Green Peas	Mankai	Total
Arm/Group Description	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	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	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 of all reporting groups
Overall Participants	12	11	13	36
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	48 (8.8)	49.5 (12.1)	48.9 (11)	48.8 (10.4)
Sex/Gender, Customized (Count of Participants)
number of man (%)	12 100%	11 100%	13 100%	36 100%
Race and Ethnicity Not Collected (Count of Participants)
Count of Participants [Participants]	0 0%
Region of Enrollment (Count of Participants)
Israel	12 100%	11 100%	13 100%	36 100%
Histidine (EAA) (µmol/L) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [µmol/L]	31.1 (4.1)	31.3 (4.1)	30 (2.9)	30.7 (3.7)
Tryptophan (EAA) (µmol/L) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [µmol/L]	14.2 (2.9)	13.8 (3.5)	12.4 (2.5)	13.4 (3)
Phenylalanine (EAA) (µmol/L) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [µmol/L]	67.4 (13.5)	60.3 (10.2)	63.4 (8.5)	63.8 (10.9)
Methionine (EAA) (µmol/L) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [µmol/L]	30.3 (7.4)	25.6 (4.2)	28.2 (6.1)	28.1 (6.2)
Threonine (EAA) (µmol/L) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [µmol/L]	31.2 (6.7)	29.9 (6.8)	30.2 (5.7)	30.5 (6.2)
Lysine (EAA) (µmol/L) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [µmol/L]	81 (24.9)	73.2 (22.2)	72.7 (19.5)	75.6 (21.9)
Valine (EAA) (µmol/L) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [µmol/L]	187.1 (31.2)	179.3 (36.3)	184.4 (25)	183.7 (30.2)
Isoleucine/leucine (EAA) (µmol/L) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [µmol/L]	141.8 (27.2)	129 (26.6)	139.7 (19.6)	137.1 (24.5)

Outcome Measures

1. Primary Outcome

Title	Amino Acid Profile (Blood Biomarkers)
Description	will be analysed by metabolomic for amino acid profile (trajectory)
Time Frame	3 hours

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	White Cheese	Green Peas	Mankai
Arm/Group Description	Essential amino acids (mmol/L)	Essential amino acids	Essential amino acids
Measure Participants	12	11	13
Mean (Standard Deviation) [mmol/L]	31.1 (4.1)	31.1 (4.1)	30 (2.9)

2. Secondary Outcome

Title	Glycemic Profile
Description	glucose (blood biomarkers)
Time Frame	3 hours

Outcome Measure Data

Analysis Population Description

glucose

Arm/Group Title	White Cheese	Green Peas	Mankai
Arm/Group Description	blood biomarkers of glycemia	blood biomarkers of glycemia	blood biomarkers of glycemia
Measure Participants	12	11	13
Mean (Standard Deviation) [mg/dL]	97.5 (13.4)	96 (9.2)	96.7 (9.4)

3. Secondary Outcome

Title	Lipid Profile
Description	HDL cholesterol fractions (blood biomarkers)
Time Frame	3 hours

Outcome Measure Data

Analysis Population Description

cholesterol fractions

Arm/Group Title	White Cheese	Green Peas	Mankai
Arm/Group Description	cholesterol fractions	cholesterol fractions	cholesterol fractions
Measure Participants	12	11	13
Mean (Standard Deviation) [mg/dL]	45.3 (9.9)	41.9 (9.3)	44.4 (7.8)

4. Secondary Outcome

Title	Liver Function
Description	ALT (blood biomarkers)
Time Frame	3 hours

Outcome Measure Data

Analysis Population Description

ALT

Arm/Group Title	Soft Cheese	Green Peas	Mankai
Arm/Group Description	ALT measured in blood	ALT measured in blood	ALT measured in blood
Measure Participants	12	11	13
Mean (Standard Deviation) [U/l]	43.2 (13.2)	42.3 (21.1)	46 (19.5)

5. Secondary Outcome

Title	Minerals
Description	potassium (blood measures)
Time Frame	3 hours

Outcome Measure Data

Analysis Population Description

potassium

Arm/Group Title	White Cheese	Green Peas	Mankai
Arm/Group Description	potassium levels	potassium levels	potassium levels
Measure Participants	12	11	13
Mean (Standard Deviation) [mmol/L]	4.5 (0.2)	4.7 (0.3)	4.5 (0.2)

6. Secondary Outcome

Title	Vitamins
Description	B12 (blood measures)
Time Frame	3 hours

Outcome Measure Data

Analysis Population Description

B12

Arm/Group Title	White Cheese	Green Peas	Mankai
Arm/Group Description	Vitamin B12 (blood measures)	Vitamin B12 (blood measures)	Vitamin B12 (blood measures)
Measure Participants	12	11	13
Mean (Standard Deviation) [pg/mL]	371.1 (146.4)	473 (144.1)	423 (220.4)

7. Secondary Outcome

Title	Glycemic Profile-Insulin
Description	Insulin (blood biomarker)
Time Frame	3 hours

Outcome Measure Data

Analysis Population Description

Insulin

Arm/Group Title	White Cheese	Green Peas	Mankai
Arm/Group Description	blood biomarkers of glycemia	blood biomarkers of glycemia	blood biomarkers of glycemia
Measure Participants	12	11	13
Mean (Standard Deviation) [mg/dL]	97.5 (13.4)	96 (9.2)	96.7 (9.4)

8. Secondary Outcome

Title	Triglycerides
Description	Triglycerides levels- Lipid profile
Time Frame	3 hours

Outcome Measure Data

Analysis Population Description

Triglycerides

Arm/Group Title	White Cheese	Green Peas	Mankai
Arm/Group Description	Triglycerides	Triglycerides	Triglycerides
Measure Participants	12	11	13
Mean (Standard Deviation) [mg/dl]	172.2 (77)	198 (111.7)	207.9 (83)

9. Secondary Outcome

Title	Liver Enzymes- ASAT
Description	ASAT - Liver enzymes
Time Frame	3 hours

Outcome Measure Data

Analysis Population Description

ASAT

Arm/Group Title	Soft Cheese	Green Peas	Mankai
Arm/Group Description	ASATmeasured in blood	ASATmeasured in blood	ASAT measured in blood
Measure Participants	12	11	13
Mean (Standard Deviation) [μKat/L]	0.53 (0.09)	0.49 (0.09)	0.51 (0.18)

10. Secondary Outcome

Title	Magnesium
Description	Magnesium levels
Time Frame	3 hours

Outcome Measure Data

Analysis Population Description

Magnesium levels

Arm/Group Title	White Cheese	Green Peas	Mankai
Arm/Group Description	Magnesium levels	Magnesium levels	Magnesium levels
Measure Participants	12	11	13
Mean (Standard Deviation) [mmol/L]	0.87 (0.072)	0.95 (0.28)	0.91 (0.054)

Adverse Events

Time Frame	3 hours
Arm/Group Title	White Cheese		Green Peas		Mankai
Arm/Group Description	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		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		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
All Cause Mortality
	White Cheese		Green Peas		Mankai
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/12 (0%)		0/11 (0%)		0/13 (0%)
Serious Adverse Events
	White Cheese		Green Peas		Mankai
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/12 (0%)		0/11 (0%)		0/13 (0%)
Other (Not Including Serious) Adverse Events
	White Cheese		Green Peas		Mankai
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/12 (0%)		0/11 (0%)		0/13 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.