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

NCT02988999 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2016-12-12

No results posted yet for this study

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

Conditions

Interventions

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.

DIETARY_SUPPLEMENT

erythritol

non-calorie sweetener

Sponsors & Collaborators

  • Kagawa University

    collaborator OTHER

  • Chiang Mai University

    lead OTHER

Principal Investigators

  • Supawan Buranapin, MD · Chiang Mai University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2016-09-30
Primary Completion
2017-08-31
Completion
2017-11-30

Countries

  • Thailand

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02988999 on ClinicalTrials.gov