Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Harvard School of Public Health (HSPH) | OTHER |
| University of Leipzig | OTHER |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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:
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| White cheese | Active Comparator | Reference group- animal protein food source: White cheese (contains 30g protein), intact, plus 250ml mineral water |
|
| Green peas | Experimental | Plant food source: Green peas (contains 30g protein), intact, cooked, plus 250ml mineral water |
|
| Mankai | Experimental | Plant food source: Wolffia globosa (Mankai, contains 30g protein), intact, cooked, plus 250ml mineral water |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| White cheese | Dietary Supplement | animal protein food source: White cheese (contains 30g protein), intact, plus 250ml mineral water |
|
| Measure | Description | Time Frame |
|---|---|---|
| Amino Acid Profile (Blood Biomarkers) | will be analysed by metabolomic for amino acid profile (trajectory) | 3 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Glycemic Profile | glucose (blood biomarkers) | 3 hours |
| Lipid Profile | HDL cholesterol fractions (blood biomarkers) | 3 hours |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Shai | Ben-Gurion University of the Negev | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| nuclear research center Negev | Dimona | Israel |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30591380 | Derived | 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. |
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| FG001 | 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 |
| FG002 | 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 |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| BG001 | Green Peas |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Amino Acid Profile (Blood Biomarkers) | will be analysed by metabolomic for amino acid profile (trajectory) | Essential amino acids (mmol/L) for the 3 groups | Posted | Mean | Standard Deviation | mmol/L | 3 hours |
|
3 hours
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 |
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Prof. Iris Shai | BGU | +972 52-579-3040 | irish@bgu.ac.il |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jan 9, 2017 | Jul 25, 2021 | Prot_SAP_000.pdf |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Green peas | Dietary Supplement | Green peas (contains 30g protein), intact, cooked, plus 250ml mineral water |
|
| Mankai | Dietary Supplement | Wolffia globosa (Mankai, contains 30g protein), intact, cooked, plus 250ml mineral water |
|
| Liver Function | ALT (blood biomarkers) | 3 hours |
| Minerals | potassium (blood measures) | 3 hours |
| Vitamins | B12 (blood measures) | 3 hours |
| Glycemic Profile-Insulin | Insulin (blood biomarker) | 3 hours |
| Triglycerides | Triglycerides levels- Lipid profile | 3 hours |
| Liver Enzymes- ASAT | ASAT - Liver enzymes | 3 hours |
| Magnesium | Magnesium levels | 3 hours |
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 |
| BG002 | 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 |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex/Gender, Customized | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| Histidine (EAA) | Mean | Standard Deviation | µmol/L |
|
| Tryptophan (EAA) | Mean | Standard Deviation | µmol/L |
|
| Phenylalanine (EAA) | Mean | Standard Deviation | µmol/L |
|
| Methionine (EAA) | Mean | Standard Deviation | µmol/L |
|
| Threonine (EAA) | Mean | Standard Deviation | µmol/L |
|
| Lysine (EAA) | Mean | Standard Deviation | µmol/L |
|
| Valine (EAA) | Mean | Standard Deviation | µmol/L |
|
| Isoleucine/leucine (EAA) | Mean | Standard Deviation | µmol/L |
|
|
|
| Secondary | Glycemic Profile | glucose (blood biomarkers) | glucose | Posted | Mean | Standard Deviation | mg/dL | 3 hours |
|
|
|
| Secondary | Lipid Profile | HDL cholesterol fractions (blood biomarkers) | cholesterol fractions | Posted | Mean | Standard Deviation | mg/dL | 3 hours |
|
|
|
| Secondary | Liver Function | ALT (blood biomarkers) | ALT | Posted | Mean | Standard Deviation | U/l | 3 hours |
|
|
|
| Secondary | Minerals | potassium (blood measures) | potassium | Posted | Mean | Standard Deviation | mmol/L | 3 hours |
|
|
|
| Secondary | Vitamins | B12 (blood measures) | B12 | Posted | Mean | Standard Deviation | pg/mL | 3 hours |
|
|
|
| Secondary | Glycemic Profile-Insulin | Insulin (blood biomarker) | Insulin | Posted | Mean | Standard Deviation | mg/dL | 3 hours |
|
|
|
| Secondary | Triglycerides | Triglycerides levels- Lipid profile | Triglycerides | Posted | Mean | Standard Deviation | mg/dl | 3 hours |
|
|
|
| Secondary | Liver Enzymes- ASAT | ASAT - Liver enzymes | ASAT | Posted | Mean | Standard Deviation | μKat/L | 3 hours |
|
|
|
| Secondary | Magnesium | Magnesium levels | Magnesium levels | Posted | Mean | Standard Deviation | mmol/L | 3 hours |
|
|
|
| 0 |
| 12 |
| 0 |
| 12 |
| 0 |
| 12 |
| EG001 | 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 | 0 | 11 | 0 | 11 | 0 | 11 |
| EG002 | 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 | 0 | 13 | 0 | 13 | 0 | 13 |
Not provided
Not provided