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临床试验/NCT03020225
NCT03020225已完成不适用

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

Ben-Gurion University of the Negev1 个研究点 分布在 1 个国家目标入组 36 人开始时间: 2016年12月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
36
试验地点
1
主要终点
Amino Acid Profile (Blood Biomarkers)

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
None

入排标准

年龄范围
30 Years 至 —(Adult, Older Adult)
性别
Male
接受健康志愿者
是

入选标准

  • •age >30 years; abdominal adiposity (waist circumference: men > 102 cm, women > 88 cm) or dyslipidemia

排除标准

  • •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)

研究组 & 干预措施

White cheese

Active Comparator

Reference group- animal protein food source: White cheese (contains 30g protein), intact, plus 250ml mineral water

干预措施: White cheese (Dietary Supplement)

Green peas

Experimental

Plant food source: Green peas (contains 30g protein), intact, cooked, plus 250ml mineral water

干预措施: Green peas (Dietary Supplement)

Mankai

Experimental

Plant food source: Wolffia globosa (Mankai, contains 30g protein), intact, cooked, plus 250ml mineral water

干预措施: Mankai (Dietary Supplement)

结局指标

主要结局

Amino Acid Profile (Blood Biomarkers)

时间窗: 3 hours

will be analysed by metabolomic for amino acid profile (trajectory)

次要结局

  • Magnesium(3 hours)
  • Glycemic Profile(3 hours)
  • Glycemic Profile-Insulin(3 hours)
  • Lipid Profile(3 hours)
  • Liver Function(3 hours)
  • Minerals(3 hours)
  • Liver Enzymes- ASAT(3 hours)
  • Vitamins(3 hours)
  • Triglycerides(3 hours)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Iris Shai

Principle investigator

Ben-Gurion University of the Negev

研究点 (1)

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