Efficacy of D-allulose on Weight and Fat Loss and Insulin Resistance in Non-diabetic Obese Subjects
Keywords
Abstract
Description
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.
The eligible subjects will be randomized with an equal probability of receiving either pure D-allulose 5 g 3 times a day from 30 min before meal to right after meals (with any liquid) plus conventional therapy or placebo (non-calorie sweetener erythritol) 5 g 3 times a day from 30 min before meal to right after meal (with any liquid) plus conventional therapy for 24 weeks. Both the subjects and the investigator will be blinded to the type of the product. Subjects in both groups will be instructed to modify their lifestyle to control their diet to 1200 kcal for women and 1500 kcal for men and increase physical activity.
Subjects will be asked to do 3-d food record per week (2 working days and 1 weekend) entire of the study. Subjects will need to record any exercise they do including type and duration during in the study. Subjects will be asked to visit every 4 weeks for follow-up for totally 9 visits including screening day or D -7, D0, end of week 4, 8, 12, 16, 20, 24 and 4 weeks post intervention (at the end of week 28) in 29 weeks duration.
Assessment of insulin resistance index (IRI) was calculated from the homeostasis model assessment of insulin resistance (HOMA-IR) using FPG (mmol/L) multiply by fasting insulin (U/ml) divided with 22.5.
The satisfaction of the product will be asked at 4 weeks, 12 weeks and 24 weeks after consumption of the study products.
From the visit 1 to visit 8, same blood samples as the screening will be measured.
At the screening visit, visit 4 and visit 7, CT abdomen measurements will be conducted.
At the visit 1 and visit 7, adiponectin, leptin, tumor necrosis factor -alpha will be measured.
At the visit 1, visit 4, visit 7 and visit 8, other lipid profiles will be measured including very low-density lipoprotein and Chylomicron fractionation , Apolipoprotein (AI, AII，C-III, E), Apolipoprotein (B48, B100), nonesterified fatty acid
Adverse Event Assessment At each visit, subjects will be asked an open question as if he/she has experienced any abnormal symptoms. Any symptom reported by the subject will be recorded as an adverse events with details of the event, its severity, start and stop dates, and relationship to study products.
Withdrawal criteria
1. Consume study product less than 90% during treatment period
2. Start taking any medication that may affect body weight during in the study.
Dates
| Last Verified: | 11/30/2016 |
| First Submitted: | 11/20/2016 |
| Estimated Enrollment Submitted: | 12/07/2016 |
| First Posted: | 12/11/2016 |
| Last Update Submitted: | 12/07/2016 |
| Last Update Posted: | 12/11/2016 |
| Actual Study Start Date: | 08/31/2016 |
| Estimated Primary Completion Date: | 07/31/2017 |
| Estimated Study Completion Date: | 10/31/2017 |
Condition or disease
Intervention/treatment
Dietary Supplement: D-allulose
Dietary Supplement: erythritol
Phase
Arm Groups
| Arm | Intervention/treatment |
|---|---|
| Experimental: D-allulose D-allulose 5 gm 3 times a day | Dietary Supplement: D-allulose D-allulose (psicose), a C-3 epimer of D-fructose, is defined one of the rare sugars since it is rarely found in nature. Rare sugars are monosaccharides which present in small quantities in commercial mixtures of D-glucose and D-fructose obtained from hydrolysis of sucrose or isomerization of D-glucose (5). D-allulose (psicose) has been demonstrated to be a non-calorie monosaccharide which has approximately 70% sweetness of sucrose. Various physiological activities of D-allulose (psicose) have been revealed. Of those, its glucose suppressive effect has been proven by both animal and clinical studies. |
| Active Comparator: erythritol erythritol 5 gm 3 times a day | Dietary Supplement: erythritol non-calorie sweetener |
Eligibility Criteria
| Ages Eligible for Study | 18 Years To 18 Years |
| Sexes Eligible for Study | All |
| Accepts Healthy Volunteers | Yes |
| Criteria | Inclusion Criteria: 1. Male or female, age > 18 years and legal age of consent. 2. 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. 3. Obesity, defined as BMI ≥ 25 kg/m2 4. Stable weight (weight change no more than 5% within 3 months) 5. 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. 6. The subject has provided written informed consent prior to admission to the study. Exclusion Criteria: A subject will be excluded from the study for any of the following reasons: 1. Pregnancy or lactation 2. Diagnosed with diabetes mellitus 3. Weight change ≥ 5 % within 3 months prior to admission to the study 4. Has taken any weight loss medications within 3 months prior to admission to the study 5. Immunocompromised status, including a debilitated state or malignancy 6. Active liver, renal, thyroid diseases 7. 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 8. Has gastrointestinal symptoms such as nausea, vomiting, loss of appetite, premature satiety, diarrhea, or chronic constipation 9. Lack of ability or willingness to give informed consent 10. 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 11. Enrolled in any other clinical study within 3 months before enrolment |
Outcome
Primary Outcome Measures
1. Body composition change after 24 weeks of D-allulose consumption to erythritol consumption [28 weeks (assess 4 weeks after 24 weeks consumption of the study product)]
2. Body weight change after 24 weeks of D-allulose consumption to erythritol consumption [28 weeks (assess 4 weeks after 24 weeks consumption of the study product)]
3. BMI change after 24 weeks of D-allulose consumption to erythritol consumption [28 weeks (assess 4 weeks after 24 weeks consumption of the study product)]
4. Body fat percentage change after 24 weeks of D-allulose consumption to erythritol consumption [28 weeks (assess 4 weeks after 24 weeks consumption of the study product)]
Secondary Outcome Measures
1. 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)]
2. 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)]
3. 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)]
4. 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)]
5. Change in lipid profiles [28 weeks (assess 4 weeks after 24 weeks consumption of the study product)]
6. Changes on waist circumference, hip circumference [28 weeks (assess 4 weeks after 24 weeks consumption of the study product)]
7. Changes on waist/ hip ratio [28 weeks (assess 4 weeks after 24 weeks consumption of the study product)]
8. Adverse events by monitoring clinical and laboratory data [28 weeks (assess 4 weeks after 24 weeks consumption of the study product)]
