Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT03020225 |
| Other study ID # |
BenGurionU |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
December 2016 |
| Est. completion date |
July 2017 |
Study information
| Verified date |
January 2022 |
| Source |
Ben-Gurion University of the Negev |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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.
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.
