title: Safety evaluation of the consumption of high dose milk fat globule membrane in healthy adults: a double-blind, randomized controlled trial with parallel group design.
abstract: Consumption of milk fat globule membrane (MFGM) in combination with habitual exercise suppresses age-associated muscle loss. The effects of high dose MFGM, however, are not known. A double-blind, randomized controlled trial with parallel group design was conducted to evaluate the safety of consuming high dose MFGM tablets. The subjects were 32 healthy adult men and women. Subjects were given 5 times the recommended daily intake of the tablets containing 6.5 g of MFGM or whole milk powder for 4 weeks. Stomach discomfort and diarrhea were observed; however, these symptoms were transitory and slight and were not related to consumption of the test tablets. In addition, there were no clinically significant changes in anthropometric measurements or blood tests. Total degree of safety assessed by the physicians of all subjects was "safe." These findings suggest that consumption of the tablets containing 6.5 g MFGM for 4 weeks is safe for healthy adults.
authors.affiliation: a Health Care Food Research Laboratories, Kao Corporation , Tokyo , Japan.
authors.forename: Sayaka
authors.initials: S
authors.lastname: Hari
authors.forename: Ryuji
authors.initials: R
authors.lastname: Ochiai
authors.forename: Yasushi
authors.initials: Y
authors.lastname: Shioya
authors.forename: Yoshihisa
authors.initials: Y
authors.lastname: Katsuragi
mesh_terms: D000328:Adult; D001774:Blood Chemical Analysis; D001835:Body Weight / Q000187:drug effects; D003371:Cough / Q000139:chemically induced; D003967:Diarrhea / Q000139:chemically induced; D019587:Dietary Supplements; D004311:Double-Blind Method; D005260:Female; D006017:Glycolipids / Q000008:administration & dosage* / Q000009:adverse effects*; D006023:Glycoproteins / Q000008:administration & dosage* / Q000009:adverse effects*; D006801:Humans; D066292:Lipid Droplets; D008297:Male; D008875:Middle Aged; D064167:Recommended Dietary Allowances; D012220:Rhinitis / Q000139:chemically induced; D013607:Tablets; D016482:Urinalysis
chemical_list: D006017:Glycolipids; D006023:Glycoproteins; D013607:Tablets; C110367:milk fat globule
keywords: clinical trial; milk fat globule membrane (MFGM); safety