The Efficacy of D-allulose (Psicose) on Weight and Fat Loss and Insulin Resistance by a Randomized Double-blind, Parallel-group Study in Non-diabetic Obese Subjects
试验速览
- 阶段
- 不适用
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Body composition change after 24 weeks of D-allulose consumption to erythritol consumption
研究概览
简要总结
Prospective, randomized, double-blind, controlled-trial 30 subjects in each groups Group - I consume pure D-allulose 5 g 3 times a day before meal to right after meal (with any liquid) and Group - II control group with non-calorie sweetener erythritol 5 g 3 times a day before meal to right after meal (with any liquid) Total number: n = 60 Either males or females, non-diabetic, aged > 18 years old with BMI ≥ 25 kg/m2
Primary objectives Efficacy
- Compare the efficacy of pure D-allulose (psicose) plus conventional therapy on 1.1 visceral fat area (VFA), subcutaneous fat area (SFA), total fat area (TFA) change 1.2 body weight, BMI and body fat percentage (with impedance method) change after 24 weeks of D-allulose (psicose) consumption to erythritol consumption and between pre- and post-intervention.
Secondary objectives 1. Efficacy of pure D-allulose (psicose) plus conventional therapy versus erythritol plus conventional therapy on 1.1 insulin resistance, fasting plasma glucose, HbA1c 1.2 adiponectin, leptin and tumor necrosis factor-alpha, lipid profiles (total cholesterol, HDL-C, LDL-C, triglyceride, very low-density lipoprotein, LDL, chylomicron), apolipoprotein AI, apolipoprotein AII,apolipoprotein B48, apolipoprotein CIII and apolipoprotein E, free fatty acids 1.4 waist circumference, hip circumference, waist/hip ratio
Safety
- Safety of the study by comparing with conventional therapy, monitoring blood pressure, pulse rate, hematological parameters and urinalysis
详细描述
Subjects and methods Study product The test product is the pure D-allulose which is a rare sugar. The control product is the non-calorie sweetener erythritol.
Study design This is a single center, prospective, randomized, control trial. After informed consent is obtained, history taking and physical examination will be performed to ensure that the patients met all inclusion criteria and had no exclusion criteria.
At the screening day, venous blood samples will be collected following an overnight fasting of at least 8 hours. Complete blood count (CBC), chemistry including fasting plasma glucose (FPG), glycated hemoglobin (HbA1c), insulin, blood urea nitrogen (BUN), creatinine, lipid profiles (total cholesterol, HDL-C, LDL-C, triglyceride, very low-density lipoprotein), blood urea nitrogen, creatinine, total protein, Albumin, albumin/globulin ratio, glutamine oxaloacetic transaminase (GOT), glutamic pyruvic transaminase (GPT) , Gamma-glutamyl transpeptidase (GGT), lactate dehydrogenase (LDH), total bilirubin (including Direct and Indirect), alkaline phosphatase, uric acid, plasma amylase, cholinesterase, Sodium, Chloride, potassium, carbon dioxide , Calcium, inorganic phosphate, magnesium, plasma iron will be measured.
Urine will be collected for urinalysis and urine pregnancy test will be performed to exclude pregnant women from the study.
Visceral fat area (VFA), subcutaneous fat area (SFA), total fat area (TFA) will be measured with abdominal CT scan at umbilical level (L4) and bioelectrical impedance at D-7 or screening visit.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male or female, age > 18 years and legal age of consent.
- •If female, the subject is either post-menopausal or surgically sterilized, or has a negative urine pregnancy test within 7 days prior to enrollment and will use adequate contraception during the study.
- •Obesity, defined as BMI ≥ 25 kg/m2
- •Stable weight (weight change no more than 5% within 3 months)
- •If subject has been treated with medications that might cause weight change (such as corticosteroid, antidepressant, antipsychotics, oral contraceptive pills) prior to admission, he/she must have taken the medication regularly at a steady dose for at least 8 weeks up.
- •The subject has provided written informed consent prior to admission to the study.
排除标准
- •A subject will be excluded from the study for any of the following reasons:
- •Pregnancy or lactation
- •Diagnosed with diabetes mellitus
- •Weight change ≥ 5 % within 3 months prior to admission to the study
- •Has taken any weight loss medications within 3 months prior to admission to the study
- •Immunocompromised status, including a debilitated state or malignancy
- •Active liver, renal, thyroid diseases
- •Frequent alcoholic consumption more than twice a week; with beer > 360 mL, alcohol > 45 mL, wine > 150 mL for female, or beer > 720 mL, whisky > 90 mL, wine > 300 mL for male each time
- •Has gastrointestinal symptoms such as nausea, vomiting, loss of appetite, premature satiety, diarrhea, or chronic constipation
- •Lack of ability or willingness to give informed consent
- •Taken any medications than might cause weight loss or weight gain such as corticosteroid, antidepressant, antipsychotics, oral contraceptive pills < 8 weeks or change the dose of these medication with 8 week prior to admission
- •Enrolled in any other clinical study within 3 months before enrolment
结局指标
主要结局
Body composition change after 24 weeks of D-allulose consumption to erythritol consumption
时间窗: 28 weeks (assess 4 weeks after 24 weeks consumption of the study product)
Body weight change after 24 weeks of D-allulose consumption to erythritol consumption
时间窗: 28 weeks (assess 4 weeks after 24 weeks consumption of the study product)
BMI change after 24 weeks of D-allulose consumption to erythritol consumption
时间窗: 28 weeks (assess 4 weeks after 24 weeks consumption of the study product)
Body fat percentage change after 24 weeks of D-allulose consumption to erythritol consumption
时间窗: 28 weeks (assess 4 weeks after 24 weeks consumption of the study product)
次要结局
- HbA1c change after 24 weeks of D-allulose consumption to erythritol consumption(28 weeks (assess 4 weeks after 24 weeks consumption of the study product))
- Change in inflammatory markers (adiponectin, leptin and tumor necrosis factor-alpha) after 24 weeks of D-allulose consumption to erythritol consumption(28 weeks (assess 4 weeks after 24 weeks consumption of the study product))
- Change in lipid profiles(28 weeks (assess 4 weeks after 24 weeks consumption of the study product))
- Changes on waist circumference, hip circumference(28 weeks (assess 4 weeks after 24 weeks consumption of the study product))
- Changes on waist/ hip ratio(28 weeks (assess 4 weeks after 24 weeks consumption of the study product))
- Adverse events by monitoring clinical and laboratory data(28 weeks (assess 4 weeks after 24 weeks consumption of the study product))
- insulin resistance change (as calculated from HOMA-IR) after 24 weeks of D-allulose consumption to erythritol consumption(28 weeks (assess 4 weeks after 24 weeks consumption of the study product))
- Fasting plasma glucose change after 24 weeks of D-allulose consumption to erythritol consumption(28 weeks (assess 4 weeks after 24 weeks consumption of the study product))
研究者
Supawan Buranapin
Assisstant professor
Chiang Mai University