Protein Bioavailability of Wolffia Globosa (Mankai); Acute Test Meal Effects (Mankai)

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.

Study Overview

• Status: Completed
• Conditions: Men With Mild Abdominal Obesity
• Intervention / Treatment: Dietary supplement: White cheese; Dietary supplement: Green peas; Dietary supplement: Mankai

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.

• Study Type: Interventional
• Enrollment (Actual): 36
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Israel
  • Dimona, Israel
    • nuclear research center Negev

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: White cheese; Reference group- animal protein food source: White cheese (contains 30g protein), intact, plus 250ml mineral water	Dietary supplement: White cheese; animal protein food source: White cheese (contains 30g protein), intact, plus 250ml mineral water
Experimental: Green peas; Plant food source: Green peas (contains 30g protein), intact, cooked, plus 250ml mineral water	Dietary supplement: Green peas; Green peas (contains 30g protein), intact, cooked, plus 250ml mineral water
Experimental: Mankai; Plant food source: Wolffia globosa (Mankai, contains 30g protein), intact, cooked, plus 250ml mineral water	Dietary supplement: Mankai; Wolffia globosa (Mankai, contains 30g protein), intact, cooked, plus 250ml mineral water

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Amino Acid Profile (Blood Biomarkers)	will be analysed by metabolomic for amino acid profile (trajectory)	3 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Glycemic Profile	glucose (blood biomarkers)	3 hours
Lipid Profile	HDL cholesterol fractions (blood biomarkers)	3 hours
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

Collaborators and Investigators

• Sponsor: Ben-Gurion University of the Negev
• Collaborators: University of Leipzig; Harvard School of Public Health (HSPH)
• Investigators: Principal Investigator: Shai, Ben-Gurion University of the Negev

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: December 1, 2016
• Primary Completion (Actual): February 1, 2017
• Study Completion (Actual): July 1, 2017

Study Registration Dates

• First Submitted: January 9, 2017
• First Submitted That Met QC Criteria: January 11, 2017
• First Posted (Estimate): January 13, 2017

Study Record Updates

• Last Update Posted (Actual): April 5, 2022
• Last Update Submitted That Met QC Criteria: January 31, 2022
• Last Verified: January 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Overnutrition; Nutrition Disorders; Obesity; Obesity, Abdominal
• Other Study ID Numbers: BenGurionU

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No