2. Materials and Methods
natto, TG
OBESE
This study was a single-center, 2-month, comparative, two-arm, randomized, open-label trial performed between 12 July 2017, and 10 November 2017. The protocol was approved by the Committee of Ethics in the Institute of Medical Science, Asahi Life Foundation (approval number 08902). Informed consent was obtained from all subjects involved in the study. Investigations were carried out in accordance with the principals of the Declaration of Helsinki. The subjects consisted of 42, obese (median BMI 28.4 kg/mThe subjects were randomly assigned, using the envelope method, to receive a two-month low-carbohydrate diet intervention (LCD [120 g carbohydrate/day] or VLCD [50 g carbohydrate/day]), as shown in All study foods (breakfast, lunch, snack and dinner) were provided by the examiners during the study period (Senior Life Create Japan Inc., Tokyo, Japan and RIZAP GROUP Inc., Tokyo, Japan). Meals were carefully designed to provide specified amounts of macronutrients and to contain sufficient fibers; they consisted of seafood and plant-derived protein, such as soybeans and fresh vegetables (The actual breakfast menu is shown. LCD: Fish and sauté with bean paste, vegetable side dish, 60 g rice and natto with egg. VLCD: Fish and sauté with bean paste, bran bread, natto with egg and yogurt.The total energy intake was individually calculated based on the ideal body weight and physical activity index. As per the JDS guidelines, total energy intake (kcal) = ideal body weight (kg = height (m) × height (m) × 22) × physical activity index (25–30 with normal intensity activity). The ratio of the three macronutrients in the LCD group was set so that protein accounted for 27%, fat for 47% and carbohydrates for 26% of the total energy. On the other hand, the ratio of the three macronutrients in the VLCD group was set so that protein accounted for 27%, fat for 61%, and carbohydrates for 12% of the total energy (The case of 1800 kcal/day is noted as an example.).In this study, participants were advised to maintain the same physical activity level as before the study. Each month, body weight and body composition were checked at week −4, week 0 (baseline), week 4 and week 8 using a frequency body impedance analysis (Body Composition Analyzer MC-980A, TANITA, Japan). Regarding physical activity level, an exercise questionnaire was taken before the study began, and the participants pledged not to start any new exercise. Furthermore, at each follow-up (where body composition measurements were taken), the study administrator checked for any changes in exercise practices, such as starting new exercises.Additionally, blood pressure, HbA1c (NGSP), fasting plasma glucose (FPG), serum ketone bodies (total ketone, 3-hydroxybutyric acid (3OHBA) and acetylacetic acid), kidney function (creatinine (Cr) and estimated glomerular filtration rate (eGFR)), liver function (AST, ALT and γ-glutamyl transpeptidase (γGTP)), lipid profile (total cholesterol (T-Cho), triglycerides (TG), high-density lipoprotein cholesterol (HDL-C) and low-density lipoprotein cholesterol (LDL-C)) and serum C-peptide were checked before and after the study. Finally, at the end of the study, we conducted a questionnaire analysis to check the emotional state of the subjects. In the questionnaire, participants were asked three questions: “What was good for you?”, “What was hard?” and “What do you want to do in the future?”. Answers were written freely in Japanese. To quickly and efficiently understand the main content of a collection of documents, we used the JMP pro ver. 15 word cloud software program (SAS Institute Japan, Tokyo, Japan). For the analysis, the text data were pre-processed. Specifically, translation software (Google Translate) was used in 2020. We corrected typographic errors and organized synonyms and compound words. Words that do not make sense on their own (punctuation, particles, etc.) and words used in various contexts, such as “myself,” were excluded. We defined the minimum number of characters per word as two for analysis.