An interventional study of White cheese and Green peas in Men With Mild Abdominal Obesity, sponsored by Ben-Gurion University of the Negev. Completed at 1 site in Israel. Open to male participants aged 30 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-04-05.
Sponsored by Ben-Gurion University of the Negev · Not applicable, Interventional, and Other
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.
274 studies on the registry are indexed under Obesity, Abdominal; 44 are open to participants now.
This study's enrollment of 36 is below the median of 60 across 216 interventional studies indexed under Obesity, Abdominal.
Browse Obesity, Abdominal studies →Ben-Gurion University of the Negev is the lead sponsor of 17 studies on the registry; 4 are open to participants now.
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Exclusion Criteria:
Reference group- animal protein food source: White cheese (contains 30g protein), intact, plus 250ml mineral water
Dietary Supplement: White cheese
Plant food source: Green peas (contains 30g protein), intact, cooked, plus 250ml mineral water
Dietary Supplement: Green peas
Plant food source: Wolffia globosa (Mankai, contains 30g protein), intact, cooked, plus 250ml mineral water
Dietary Supplement: Mankai
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
Amino Acid Profile (Blood Biomarkers)
will be analysed by metabolomic for amino acid profile (trajectory)
Time frame: 3 hours
Glycemic Profile
glucose (blood biomarkers)
Time frame: 3 hours
Lipid Profile
HDL cholesterol fractions (blood biomarkers)
Time frame: 3 hours
Liver Function
ALT (blood biomarkers)
Time frame: 3 hours
Minerals
potassium (blood measures)
Time frame: 3 hours
Vitamins
B12 (blood measures)
Time frame: 3 hours
Glycemic Profile-Insulin
Insulin (blood biomarker)
Time frame: 3 hours
Triglycerides
Triglycerides levels- Lipid profile
Time frame: 3 hours
Liver Enzymes- ASAT
ASAT - Liver enzymes
Time frame: 3 hours
Magnesium
Magnesium levels
Time frame: 3 hours
https://www.ncbi.nlm.nih.gov/pubmed/30591380
| Milestone | White Cheese | Green Peas | Mankai |
|---|---|---|---|
| Started | 12 | 11 | 13 |
| Completed | 12 | 11 | 13 |
| Not completed | 0 | 0 | 0 |
will be analysed by metabolomic for amino acid profile (trajectory)
| mmol/L | White Cheese | Green Peas | Mankai |
|---|---|---|---|
| Amino Acid Profile (Blood Biomarkers) | 31.1 ± 4.1 | 31.1 ± 4.1 | 30 ± 2.9 |
glucose (blood biomarkers)
| mg/dL | White Cheese | Green Peas | Mankai |
|---|---|---|---|
| Glycemic Profile | 97.5 ± 13.4 | 96 ± 9.2 | 96.7 ± 9.4 |
HDL cholesterol fractions (blood biomarkers)
| mg/dL | White Cheese | Green Peas | Mankai |
|---|---|---|---|
| Lipid Profile | 45.3 ± 9.9 | 41.9 ± 9.3 | 44.4 ± 7.8 |
ALT (blood biomarkers)
| U/l | Soft Cheese | Green Peas | Mankai |
|---|---|---|---|
| Liver Function | 43.2 ± 13.2 | 42.3 ± 21.1 | 46 ± 19.5 |
potassium (blood measures)
| mmol/L | White Cheese | Green Peas | Mankai |
|---|---|---|---|
| Minerals | 4.5 ± 0.2 | 4.7 ± 0.3 | 4.5 ± 0.2 |
B12 (blood measures)
| pg/mL | White Cheese | Green Peas | Mankai |
|---|---|---|---|
| Vitamins | 371.1 ± 146.4 | 473 ± 144.1 | 423 ± 220.4 |
Insulin (blood biomarker)
| mg/dL | White Cheese | Green Peas | Mankai |
|---|---|---|---|
| Glycemic Profile-Insulin | 97.5 ± 13.4 | 96 ± 9.2 | 96.7 ± 9.4 |
Triglycerides levels- Lipid profile
| mg/dl | White Cheese | Green Peas | Mankai |
|---|---|---|---|
| Triglycerides | 172.2 ± 77 | 198 ± 111.7 | 207.9 ± 83 |
ASAT - Liver enzymes
| μKat/L | Soft Cheese | Green Peas | Mankai |
|---|---|---|---|
| Liver Enzymes- ASAT | 0.53 ± 0.09 | 0.49 ± 0.09 | 0.51 ± 0.18 |
Magnesium levels
| mmol/L | White Cheese | Green Peas | Mankai |
|---|---|---|---|
| Magnesium | 0.87 ± 0.072 | 0.95 ± 0.28 | 0.91 ± 0.054 |
Collected over 3 hours. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| White Cheese | 0/12 (0%) | 0/12 (0%) | 0/12 (0%) |
| Green Peas | 0/11 (0%) | 0/11 (0%) | 0/11 (0%) |
| Mankai | 0/13 (0%) | 0/13 (0%) | 0/13 (0%) |
https://www.ncbi.nlm.nih.gov/pubmed/30591380
| Age, Continuous(years) | White Cheese | Green Peas | Mankai | Total |
|---|---|---|---|---|
| Mean | 48 ± 8.8 | 49.5 ± 12.1 | 48.9 ± 11 | 48.8 ± 10.4 |
| Sex/Gender, Customized(Participants) | White Cheese | Green Peas | Mankai | Total |
|---|---|---|---|---|
| number of man (%) | 12 | 11 | 13 | 36 |
| Race and Ethnicity Not Collected(Participants) | White Cheese | Green Peas | Mankai | Total |
|---|---|---|---|---|
| Count of participants | — | — | — | 0 |
| Region of Enrollment(Participants) | White Cheese | Green Peas | Mankai | Total |
|---|---|---|---|---|
| Israel | 12 | 11 | 13 | 36 |
| Histidine (EAA)(µmol/L) | White Cheese | Green Peas | Mankai | Total |
|---|---|---|---|---|
| Mean | 31.1 ± 4.1 | 31.3 ± 4.1 | 30 ± 2.9 | 30.7 ± 3.7 |
| Tryptophan (EAA)(µmol/L) | White Cheese | Green Peas | Mankai | Total |
|---|---|---|---|---|
| Mean | 14.2 ± 2.9 | 13.8 ± 3.5 | 12.4 ± 2.5 | 13.4 ± 3 |
| Phenylalanine (EAA)(µmol/L) | White Cheese | Green Peas | Mankai | Total |
|---|---|---|---|---|
| Mean | 67.4 ± 13.5 | 60.3 ± 10.2 | 63.4 ± 8.5 | 63.8 ± 10.9 |
| Methionine (EAA)(µmol/L) | White Cheese | Green Peas | Mankai | Total |
|---|---|---|---|---|
| Mean | 30.3 ± 7.4 | 25.6 ± 4.2 | 28.2 ± 6.1 | 28.1 ± 6.2 |
4 further baseline measures are reported on the registry.
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Ben-Gurion University of the Negev