Diabetes Mellitus, Type 2

Overweight and Obesity

Subjects will be given the Light-Fat Rice® combined with Active Peptide® with a lifestyle guidance to assist diabetes management. The method of taking the product has two parts: 1.Light-Fat Rice®: 80g (1 pack) per day as a staple meal replacement, used as a separate staple food or mixed with other staple foods, taking 4 weeks; 2.Active Peptide®: 20g (2 packs) per day (1 pack each morning and evening), served with 300ml of 40°C warm water each time before meals and take it for 4 weeks.

Light-Fat Rice® combined with Active Peptide®+ lifestyle guidance

A staple food of comparable energy containing a small amount of dietary fiber combined with a comparable energy maltodextrin (both produced by the same manufacturer) with a lifestyle guidance will be given by the professional to assist in diabetes management. The product is taken as follows: 1.equal-energy staple food containing a small amount of dietary fiber: 80g (1 pack) per day, used as an independent staple food or mixed with other staple foods, taking for 4 weeks; 2.equal-energy maltodextrin: 20g(2 packs) per day(1 pack each morning and evening),take it with 300ml of 40°C warm water for 4 weeks.

A staple food of comparable energy containing a small amount of dietary fiber combined with a comparable energy maltodextrin + lifestyle guidance

Dongcheng district，Peking union medical college hospital

A Clinical Trial of Overweight/Obesity With Type 2 Diabetes

Effect of Light-Fat Rice® on Blood Glucose in Overweight/Obese Patients With Type 2 Diabetes Mellitus and Related Mechanisms

Patients will be exposed to a dynamic glycemic transient monitor from the 3rd week of the study period, worn for 2 weeks, and removed at the 4th week of follow-up. During the period of wearing, the patients will be required to record the dietary diary, preprandial and postprandial (every 15 minutes) blood glucose level (mmol/L) for 3-day period (including one day of the weekend)each week, and also select 3 days per week (including one day of the weekend) to record daily exercise, pre- and post-exercise (every 30 minutes) blood glucose levels (mmol/L) .

The patients will be subjected to two blood collections throughout the study, at baseline and at the 4th week of follow-up. The insulin resistance index is calculated as HOMA-IR=［plasma glucose（GLU,mmol/L）*serum insulin(mIU/L)］/22.5.

The patients will be subjected to two blood collections throughout the study, at baseline and at the 4th week of follow-up. The glycemic control compliance rate will be compared using two fasting blood glucose values and expressed as a number (percentage).

The patients will be subjected to two blood collections throughout the study, at baseline and at the 4th week of follow-up. The change in glycated albumin (GA%) will be compared with the values of two fasting blood samples, with a normal range of 10.8%-17.1%.

The patients will be subjected to two blood collections throughout the study, at baseline and at the 4th week of follow-up. Changes in blood lipids (total cholesterol, mmol/L;triglycerides, mmol/L;high-density lipoprotein cholesterol, mmol/L; low-density lipoprotein cholesterol, mmol/L) will be compared using the values of two fasting blood samples. The normal range is 2.85-5.70 mmol/L for total cholesterol, 0.45-1.70 mmol/L for triglycerides, 1.42-11.29 mmol/L for high-density lipoprotein cholesterol, and 2.07-3.62 mmol/L for low-density lipoprotein cholesterol.

Patients will be subjected to three body weight measurements throughout the study, baseline, week 2, and week 4 of follow-up,along with their height measurements at the start of the study. Both of the height and weight will be measured with a standard instrument and recorded in meters and kilograms respectively，following a requirement of accurating to two decimal places. And the weight and height will be combined to report in a form of BMI in kg/m^2.The changes in BMI before and after the study will be expressed as mean ± SD.

The following data will be shared at the end of the study: demographic data, current medical history, past history; physical examination data collected at 3 visits, including heart rate, blood pressure, height, weight, waist circumference, hip circumference, grip strength, and human body Ingredients, etc.; previous physical examination data provided at baseline such as abdominal ultrasound; laboratory tests such as insulin levels, blood lipid levels, urinary protein levels collected at baseline and 4th week of follow-up; dietary and exercise diaries as well as the dynamic blood sugar changes along with these, etc.

Wei Chen

Peking Union Medical College Hospital,Clinical Nutrition Department,Chief Physician

Peking Union Medical College Hospital

Hebei Dongfangyun Health Management Co.,Ltd

The diet will be administered by a professional physician (intervention group:Light-Fat Rice® combined with Active Peptide®; control group: staple food of equal energy containing a small amount of dietary fiber combined with comparable energy maltodextrin) with a lifestyle guidance,same in both groups, to assist in diabetes management. The method of taking the product can be divided into two parts.And a dynamic blood glucose transient monitor would be worn for all patients at the 3rd week to record the patients's dynamic blood glucose changes including preprandial, postprandial (every 15 minutes), before and after exercise (every 30 minutes).Besides these,the patients would be asked to record dietary and exercise diary for 3 days(including one weekend at least) each week also.

T2DM (Type 2 Diabetes Mellitus)

General Population

Meta-analysis of Randomized Controlled Trials

Viscous Fibre

The Toronto 3D Knowledge Synthesis and Clinical Trials Unit, Clinical Nutrition and Risk Factor Modification Centre

Effect of Viscous Soluble Fibres on Body Weight

Effect of Viscous Soluble Fibres on Body Weight Parameters: Review and Meta-analyses

St. Michael's Hospital, Toronto

In the glucomannan noodle (GMN) diet, the participants received two servings (400 g) of GMN every day to replace their daily carbohydrate intake for 4 weeks, with each serving of glucomannan noodles weighing up to 200 g with 2 g of glucomannan.

In the placebo noodle (PN) diet, the participants received the participants received the same amount of noodles without glucomannan.

"First Intervention (4 weeks, GMN)", "Washout (2 weeks)" and "Second Intervention (4 weeks, PN)"

First GMN Then PN

"First Intervention (4 weeks, PN)", "Washout (2 weeks)" and "Second Intervention (4 weeks, GMN)"

First PN Then GMN

Total

Sex: Female, Male

Body weight by weighting scale (kilogram). Lower scores mean a better outcome in subjects.

GMN Diet

PN Diet

Body Weight

Waist Circumference

Glycemic Index

LDL-C (low density lipoprotein cholesterol) analysis

Lipid Index

Overall Study

Dr. Sing-Chung Li

The 100 g GMN noodle contains 1 g of konjac glucomannan powder. Participants approximately consumed 2 g GMN per day in 200 g of noodle. The intervention period was 4 weeks long. Meanwhile, the participants remained their usual eating habits except consuming any probiotics or prebiotics.

Isocaloric noodle with no konjac glucomannan powder in placebo comparator. The PN-participants daily consumed placebo noodle without any added GMN (approximately 200 g noodle per day). The intervention period was 4 weeks long. Meanwhile, the participants will remain their usual eating habits except consuming any probiotics or prebiotics.

Metabolic Syndrome

The participants received two servings (400 g) of GMN every day to replace their daily carbohydrate intake for 4 weeks.

Glucomannan noodle

In the placebo noodle diet, the participants received the same amount of noodles without glucomannan for 4 weeks.

Placebo noodle

Effects of Konjac Glucomannan Noodle Intervention in Subjects With Metabolic Syndrome

Office of Human Research, Taipei Medical University

Taipei Medical University

Glucomannan orally, 3g/day (in three divided doses), for 12 weeks

Maltodextrin orally, 3g/day (in three divided doses), for 12 weeks

Obesity

Overweight

Glucomannan

Maltodextrin

The Medical University of Warsaw, Department of Paediatrics

Effect of Glucomannan Supplementation on Body Weight in Overweight and Obese Children

Effect of Glucomannan Supplementation on Body Weight in Overweight and Obese Children: A Randomized Controlled Trial

Whole body fat, central body fat, fat-free mass (grams) assessed by a dual energy X-ray absorption (DXA)

Proportion of participants with dyslipidemia from baseline to week 12 and week 24 (mean change, SD)

Proportion of participants with impaired fasting plasma glucose (FPG) from baseline to week 12 and week 24 (mean change, SD).

amorphophallus titanum/obesitas

A Clinical Trial of Overweight/Obesity With Type 2 Diabetes

Effect of Viscous Soluble Fibres on Body Weight

Effects of Konjac Glucomannan Noodle Intervention in Subjects With Metabolic Syndrome

Effect of Glucomannan Supplementation on Body Weight in Overweight and Obese Children

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