Protein Bioavailability of Wolffia Globosa (Mankai); Acute Test Meal Effects (Mankai)
Primary Purpose
Men With Mild Abdominal Obesity
Status
Completed
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
White cheese
Green peas
Mankai
Sponsored by
About this trial
This is an interventional other trial for Men With Mild Abdominal Obesity
Eligibility Criteria
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)
Sites / Locations
- nuclear research center Negev
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Experimental
Experimental
Arm Label
White cheese
Green peas
Mankai
Arm Description
Reference group- 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
Plant food source: Wolffia globosa (Mankai, contains 30g protein), intact, cooked, plus 250ml mineral water
Outcomes
Primary Outcome Measures
Amino Acid Profile (Blood Biomarkers)
will be analysed by metabolomic for amino acid profile (trajectory)
Secondary Outcome Measures
Glycemic Profile
glucose (blood biomarkers)
Lipid Profile
HDL cholesterol fractions (blood biomarkers)
Liver Function
ALT (blood biomarkers)
Minerals
potassium (blood measures)
Vitamins
B12 (blood measures)
Glycemic Profile-Insulin
Insulin (blood biomarker)
Triglycerides
Triglycerides levels- Lipid profile
Liver Enzymes- ASAT
ASAT - Liver enzymes
Magnesium
Magnesium levels
Full Information
NCT ID
NCT03020225
First Posted
January 9, 2017
Last Updated
January 31, 2022
Sponsor
Ben-Gurion University of the Negev
Collaborators
Harvard School of Public Health (HSPH), University of Leipzig
1. Study Identification
Unique Protocol Identification Number
NCT03020225
Brief Title
Protein Bioavailability of Wolffia Globosa (Mankai); Acute Test Meal Effects
Acronym
Mankai
Official Title
Protein Bioavailability of Wolffia Globosa (Mankai); Acute Test Meal Effects
Study Type
Interventional
2. Study Status
Record Verification Date
January 2022
Overall Recruitment Status
Completed
Study Start Date
December 2016 (undefined)
Primary Completion Date
February 2017 (Actual)
Study Completion Date
July 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ben-Gurion University of the Negev
Collaborators
Harvard School of Public Health (HSPH), University of Leipzig
4. Oversight
Data Monitoring Committee
No
5. 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.
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:
Reference group: animal protein food source: White cheese, intact, plus 250ml mineral water
Test group 1: plant food source: Green peas, intact, cooked, plus 250ml mineral water
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Men With Mild Abdominal Obesity
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
36 (Actual)
8. Arms, Groups, and Interventions
Arm Title
White cheese
Arm Type
Active Comparator
Arm Description
Reference group- animal protein food source: White cheese (contains 30g protein), intact, plus 250ml mineral water
Arm Title
Green peas
Arm Type
Experimental
Arm Description
Plant food source: Green peas (contains 30g protein), intact, cooked, plus 250ml mineral water
Arm Title
Mankai
Arm Type
Experimental
Arm Description
Plant food source: Wolffia globosa (Mankai, contains 30g protein), intact, cooked, plus 250ml mineral water
Intervention Type
Dietary Supplement
Intervention Name(s)
White cheese
Intervention Description
animal protein food source: White cheese (contains 30g protein), intact, plus 250ml mineral water
Intervention Type
Dietary Supplement
Intervention Name(s)
Green peas
Intervention Description
Green peas (contains 30g protein), intact, cooked, plus 250ml mineral water
Intervention Type
Dietary Supplement
Intervention Name(s)
Mankai
Intervention Description
Wolffia globosa (Mankai, contains 30g protein), intact, cooked, plus 250ml mineral water
Primary Outcome Measure Information:
Title
Amino Acid Profile (Blood Biomarkers)
Description
will be analysed by metabolomic for amino acid profile (trajectory)
Time Frame
3 hours
Secondary Outcome Measure Information:
Title
Glycemic Profile
Description
glucose (blood biomarkers)
Time Frame
3 hours
Title
Lipid Profile
Description
HDL cholesterol fractions (blood biomarkers)
Time Frame
3 hours
Title
Liver Function
Description
ALT (blood biomarkers)
Time Frame
3 hours
Title
Minerals
Description
potassium (blood measures)
Time Frame
3 hours
Title
Vitamins
Description
B12 (blood measures)
Time Frame
3 hours
Title
Glycemic Profile-Insulin
Description
Insulin (blood biomarker)
Time Frame
3 hours
Title
Triglycerides
Description
Triglycerides levels- Lipid profile
Time Frame
3 hours
Title
Liver Enzymes- ASAT
Description
ASAT - Liver enzymes
Time Frame
3 hours
Title
Magnesium
Description
Magnesium levels
Time Frame
3 hours
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shai
Organizational Affiliation
Ben-Gurion University of the Negev
Official's Role
Principal Investigator
Facility Information:
Facility Name
nuclear research center Negev
City
Dimona
Country
Israel
12. IPD Sharing Statement
Citations:
PubMed Identifier
30591380
Citation
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.
Results Reference
derived
Learn more about this trial
Protein Bioavailability of Wolffia Globosa (Mankai); Acute Test Meal Effects
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