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Trial record 2 of 3 for:    Wolffia Globosa

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

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ClinicalTrials.gov Identifier: NCT03020225
Recruitment Status : Completed
First Posted : January 13, 2017
Results First Posted : April 5, 2022
Last Update Posted : April 5, 2022
Sponsor:
Collaborators:
Harvard School of Public Health (HSPH)
University of Leipzig
Information provided by (Responsible Party):
Iris Shai, Ben-Gurion University of the Negev

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.

Condition or disease Intervention/treatment Phase
Men With Mild Abdominal Obesity Dietary Supplement: White cheese Dietary Supplement: Green peas Dietary Supplement: Mankai Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 36 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Protein Bioavailability of Wolffia Globosa (Mankai); Acute Test Meal Effects
Study Start Date : December 2016
Actual Primary Completion Date : February 2017
Actual Study Completion Date : July 2017

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. Amino Acid Profile (Blood Biomarkers) [ Time Frame: 3 hours ]
    will be analysed by metabolomic for amino acid profile (trajectory)


Secondary Outcome Measures :
  1. Glycemic Profile [ Time Frame: 3 hours ]
    glucose (blood biomarkers)

  2. Lipid Profile [ Time Frame: 3 hours ]
    HDL cholesterol fractions (blood biomarkers)

  3. Liver Function [ Time Frame: 3 hours ]
    ALT (blood biomarkers)

  4. Minerals [ Time Frame: 3 hours ]
    potassium (blood measures)

  5. Vitamins [ Time Frame: 3 hours ]
    B12 (blood measures)

  6. Glycemic Profile-Insulin [ Time Frame: 3 hours ]
    Insulin (blood biomarker)

  7. Triglycerides [ Time Frame: 3 hours ]
    Triglycerides levels- Lipid profile

  8. Liver Enzymes- ASAT [ Time Frame: 3 hours ]
    ASAT - Liver enzymes

  9. Magnesium [ Time Frame: 3 hours ]
    Magnesium levels



Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03020225


Locations
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Israel
nuclear research center Negev
Dimona, Israel
Sponsors and Collaborators
Ben-Gurion University of the Negev
Harvard School of Public Health (HSPH)
University of Leipzig
Investigators
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Principal Investigator: Shai Ben-Gurion University of the Negev
  Study Documents (Full-Text)

Documents provided by Iris Shai, Ben-Gurion University of the Negev:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Iris Shai, Principle investigator, Ben-Gurion University of the Negev
ClinicalTrials.gov Identifier: NCT03020225    
Other Study ID Numbers: BenGurionU
First Posted: January 13, 2017    Key Record Dates
Results First Posted: April 5, 2022
Last Update Posted: April 5, 2022
Last Verified: January 2022
Additional relevant MeSH terms:
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Obesity, Abdominal
Obesity
Overnutrition
Nutrition Disorders