Men With Mild Abdominal Obesity
Conditions
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
animal protein food source: White cheese (contains 30g protein), intact, plus 250ml mineral water
Green peas (contains 30g protein), intact, cooked, plus 250ml mineral water
Wolffia globosa (Mankai, contains 30g protein), intact, cooked, plus 250ml mineral water
Sponsors
Study design
Eligibility
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
| Measure | Time frame | Description |
|---|---|---|
| Amino Acid Profile (Blood Biomarkers) | 3 hours | will be analysed by metabolomic for amino acid profile (trajectory) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Lipid Profile | 3 hours | HDL cholesterol fractions (blood biomarkers) |
| Liver Function | 3 hours | ALT (blood biomarkers) |
| Minerals | 3 hours | potassium (blood measures) |
| Vitamins | 3 hours | B12 (blood measures) |
| Glycemic Profile | 3 hours | glucose (blood biomarkers) |
| Triglycerides | 3 hours | Triglycerides levels- Lipid profile |
| Liver Enzymes- ASAT | 3 hours | ASAT - Liver enzymes |
| Magnesium | 3 hours | Magnesium levels |
| Glycemic Profile-Insulin | 3 hours | Insulin (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
| Arm | Count |
|---|---|
| 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 |
| Total | 36 |
Baseline characteristics
| Characteristic | Mankai | Total | White Cheese | Green Peas |
|---|---|---|---|---|
| Age, Continuous | 48.9 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 Collected | — | 0 Participants | — | — |
| Region of Enrollment Israel | 13 Participants | 36 Participants | 12 Participants | 11 Participants |
| Sex/Gender, Customized number of man (%) | 13 Participants | 36 Participants | 12 Participants | 11 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 type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 12 | 0 / 11 | 0 / 13 |
| other Total, other adverse events | 0 / 12 | 0 / 11 | 0 / 13 |
| serious Total, serious adverse events | 0 / 12 | 0 / 11 | 0 / 13 |
Outcome results
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| White Cheese | Amino Acid Profile (Blood Biomarkers) | 31.1 mmol/L | Standard Deviation 4.1 |
| Green Peas | Amino Acid Profile (Blood Biomarkers) | 31.1 mmol/L | Standard Deviation 4.1 |
| Mankai | Amino Acid Profile (Blood Biomarkers) | 30 mmol/L | Standard Deviation 2.9 |
Glycemic Profile
glucose (blood biomarkers)
Time frame: 3 hours
Population: glucose
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| White Cheese | Glycemic Profile | 97.5 mg/dL | Standard Deviation 13.4 |
| Green Peas | Glycemic Profile | 96 mg/dL | Standard Deviation 9.2 |
| Mankai | Glycemic Profile | 96.7 mg/dL | Standard Deviation 9.4 |
Glycemic Profile-Insulin
Insulin (blood biomarker)
Time frame: 3 hours
Population: Insulin
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| White Cheese | Glycemic Profile-Insulin | 97.5 mg/dL | Standard Deviation 13.4 |
| Green Peas | Glycemic Profile-Insulin | 96 mg/dL | Standard Deviation 9.2 |
| Mankai | Glycemic Profile-Insulin | 96.7 mg/dL | Standard Deviation 9.4 |
Lipid Profile
HDL cholesterol fractions (blood biomarkers)
Time frame: 3 hours
Population: cholesterol fractions
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| White Cheese | Lipid Profile | 45.3 mg/dL | Standard Deviation 9.9 |
| Green Peas | Lipid Profile | 41.9 mg/dL | Standard Deviation 9.3 |
| Mankai | Lipid Profile | 44.4 mg/dL | Standard Deviation 7.8 |
Liver Enzymes- ASAT
ASAT - Liver enzymes
Time frame: 3 hours
Population: ASAT
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| White Cheese | Liver Enzymes- ASAT | 0.53 μKat/L | Standard Deviation 0.09 |
| Green Peas | Liver Enzymes- ASAT | 0.49 μKat/L | Standard Deviation 0.09 |
| Mankai | Liver Enzymes- ASAT | 0.51 μKat/L | Standard Deviation 0.18 |
Liver Function
ALT (blood biomarkers)
Time frame: 3 hours
Population: ALT
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| White Cheese | Liver Function | 43.2 U/l | Standard Deviation 13.2 |
| Green Peas | Liver Function | 42.3 U/l | Standard Deviation 21.1 |
| Mankai | Liver Function | 46 U/l | Standard Deviation 19.5 |
Magnesium
Magnesium levels
Time frame: 3 hours
Population: Magnesium levels
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| White Cheese | Magnesium | 0.87 mmol/L | Standard Deviation 0.072 |
| Green Peas | Magnesium | 0.95 mmol/L | Standard Deviation 0.28 |
| Mankai | Magnesium | 0.91 mmol/L | Standard Deviation 0.054 |
Minerals
potassium (blood measures)
Time frame: 3 hours
Population: potassium
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| White Cheese | Minerals | 4.5 mmol/L | Standard Deviation 0.2 |
| Green Peas | Minerals | 4.7 mmol/L | Standard Deviation 0.3 |
| Mankai | Minerals | 4.5 mmol/L | Standard Deviation 0.2 |
Triglycerides
Triglycerides levels- Lipid profile
Time frame: 3 hours
Population: Triglycerides
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| White Cheese | Triglycerides | 172.2 mg/dl | Standard Deviation 77 |
| Green Peas | Triglycerides | 198 mg/dl | Standard Deviation 111.7 |
| Mankai | Triglycerides | 207.9 mg/dl | Standard Deviation 83 |
Vitamins
B12 (blood measures)
Time frame: 3 hours
Population: B12
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| White Cheese | Vitamins | 371.1 pg/mL | Standard Deviation 146.4 |
| Green Peas | Vitamins | 473 pg/mL | Standard Deviation 144.1 |
| Mankai | Vitamins | 423 pg/mL | Standard Deviation 220.4 |