UnknownNot Applicable

Efficacy of D-allulose on Weight and Fat Loss and Insulin Resistance in Non-diabetic Obese Subjects

Thailand60 participantsStarted 2016-09

Plain-language summary

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 1\. 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 1\. Safety of the study by comparing with conventional therapy, monitoring blood pressure, pulse rate, hematological parameters and urinalysis

Who can participate

Age range18 Years – 80 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. 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.

Exclusion criteria

✕. Pregnancy or lactation
✕. Diagnosed with diabetes mellitus
✕. Weight change ≥ 5 % within 3 months prior to admission to the study

What they're measuring

Body composition change after 24 weeks of D-allulose consumption to erythritol consumption

Timeframe: 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

Timeframe: 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

Timeframe: 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

Timeframe: 28 weeks (assess 4 weeks after 24 weeks consumption of the study product)

Trial details

NCT IDNCT02988999

SponsorChiang Mai University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2017-08

Contact for this trial

Supawan Buranapin, MD

66-867310392 supawan.b@cmu.ac.th

View on ClinicalTrials.gov More Obesity trials

Plain-language summary

Who can participate

Age range18 Years – 80 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. 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.

Exclusion criteria

✕. Pregnancy or lactation
✕. Diagnosed with diabetes mellitus
✕. Weight change ≥ 5 % within 3 months prior to admission to the study