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

NCT02988999 | Unknown DMC

• 1 other identifier: CMU-D-allulose02
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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

Obesity

Keywords

D-allulose or erythritol

Outcome Measures

Primary Outcomes (4)

• 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)

• 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)

• 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)

• 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 Outcomes (8)

• 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)

• 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)

Study Arms (2)

D-allulose

EXPERIMENTAL

D-allulose 5 gm 3 times a day

Dietary Supplement: D-allulose

erythritol

ACTIVE COMPARATOR

erythritol 5 gm 3 times a day

Dietary Supplement: erythritol

Interventions

D-allulose DIETARY_SUPPLEMENT

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.

D-allulose

erythritol DIETARY_SUPPLEMENT

non-calorie sweetener

erythritol

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Chiang Mai University: lead
• Kagawa University: collaborator

Study Sites (1)

Faculty of Medicine, Chiang Mai University

Muang Chiang Mai, Chiang Mai, 50200, Thailand

RECRUITING

Related Publications (17)

• Cree GM, Perlin AS. O-isopropylidene derivatives of D-allulose (D-psicose) and D-erythro-hexopyranos-2,3-diulose. Can J Biochem. 1968 Aug;46(8):765-70. doi: 10.1139/o68-117. No abstract available.

  PMID: 4299740 BACKGROUND

• Takeshita K, Suga A, Takada G, Izumori K. Mass production of D-psicose from d-fructose by a continuous bioreactor system using immobilized D-tagatose 3-epimerase. J Biosci Bioeng. 2000;90(4):453-5. doi: 10.1016/s1389-1723(01)80018-9.

  PMID: 16232889 BACKGROUND

• Granstrom TB, Takata G, Tokuda M, Izumori K. Izumoring: a novel and complete strategy for bioproduction of rare sugars. J Biosci Bioeng. 2004;97(2):89-94. doi: 10.1016/S1389-1723(04)70173-5.

  PMID: 16233597 BACKGROUND

• Matsuo T, Suzuki H, Hashiguchi M, Izumori K. D-psicose is a rare sugar that provides no energy to growing rats. J Nutr Sci Vitaminol (Tokyo). 2002 Feb;48(1):77-80. doi: 10.3177/jnsv.48.77.

  PMID: 12026195 BACKGROUND

• Matsuo T, Izumori K. d-Psicose Inhibits Intestinal alpha-Glucosidase and Suppresses the Glycemic Response after Ingestion of Carbohydrates in Rats. J Clin Biochem Nutr. 2009 Sep;45(2):202-6. doi: 10.3164/jcbn.09-36. Epub 2009 Aug 28.

  PMID: 19794929 BACKGROUND

• Iida T, Kishimoto Y, Yoshikawa Y, Hayashi N, Okuma K, Tohi M, Yagi K, Matsuo T, Izumori K. Acute D-psicose administration decreases the glycemic responses to an oral maltodextrin tolerance test in normal adults. J Nutr Sci Vitaminol (Tokyo). 2008 Dec;54(6):511-4. doi: 10.3177/jnsv.54.511.

  PMID: 19155592 BACKGROUND

• Hayashi N, Iida T, Yamada T, Okuma K, Takehara I, Yamamoto T, Yamada K, Tokuda M. Study on the postprandial blood glucose suppression effect of D-psicose in borderline diabetes and the safety of long-term ingestion by normal human subjects. Biosci Biotechnol Biochem. 2010;74(3):510-9. doi: 10.1271/bbb.90707. Epub 2010 Mar 7.

  PMID: 20208358 BACKGROUND

• Hossain A, Yamaguchi F, Matsunaga T, Hirata Y, Kamitori K, Dong Y, Sui L, Tsukamoto I, Ueno M, Tokuda M. Rare sugar D-psicose protects pancreas beta-islets and thus improves insulin resistance in OLETF rats. Biochem Biophys Res Commun. 2012 Sep 7;425(4):717-23. doi: 10.1016/j.bbrc.2012.07.135. Epub 2012 Aug 1.

  PMID: 22877751 BACKGROUND

• Ochiai M, Onishi K, Yamada T, Iida T, Matsuo T. D-psicose increases energy expenditure and decreases body fat accumulation in rats fed a high-sucrose diet. Int J Food Sci Nutr. 2014 Mar;65(2):245-50. doi: 10.3109/09637486.2013.845653. Epub 2013 Oct 21.

  PMID: 24144428 BACKGROUND

• Matsuo T, Izumori K. Effects of dietary D-psicose on diurnal variation in plasma glucose and insulin concentrations of rats. Biosci Biotechnol Biochem. 2006 Sep;70(9):2081-5. doi: 10.1271/bbb.60036. Epub 2006 Sep 7.

  PMID: 16960391 BACKGROUND

• Ochiai M, Nakanishi Y, Yamada T, Iida T, Matsuo T. Inhibition by dietary D-psicose of body fat accumulation in adult rats fed a high-sucrose diet. Biosci Biotechnol Biochem. 2013;77(5):1123-6. doi: 10.1271/bbb.130019. Epub 2013 May 7.

  PMID: 23649241 BACKGROUND

• Chung YM, Hyun Lee J, Youl Kim D, Hwang SH, Hong YH, Kim SB, Jin Lee S, Hye Park C. Dietary D-psicose reduced visceral fat mass in high-fat diet-induced obese rats. J Food Sci. 2012 Feb;77(2):H53-8. doi: 10.1111/j.1750-3841.2011.02571.x.

  PMID: 22339545 BACKGROUND

• Wong JM, de Souza R, Kendall CW, Emam A, Jenkins DJ. Colonic health: fermentation and short chain fatty acids. J Clin Gastroenterol. 2006 Mar;40(3):235-43. doi: 10.1097/00004836-200603000-00015.

  PMID: 16633129 BACKGROUND

• Haslam DW, James WP. Obesity. Lancet. 2005 Oct 1;366(9492):1197-209. doi: 10.1016/S0140-6736(05)67483-1.

  PMID: 16198769 BACKGROUND

• The Western Pacific Region, World Health Organization, International Associates for the study of obesity, International Obesity Task Force. The Asia-Pacific Perspective: redefining obesity and its treatment. Melbourne: Health Communications Australia, 2000.

  BACKGROUND

• Fontaine KR, Redden DT, Wang C, Westfall AO, Allison DB. Years of life lost due to obesity. JAMA. 2003 Jan 8;289(2):187-93. doi: 10.1001/jama.289.2.187.

  PMID: 12517229 BACKGROUND

• Johnson WD, Brashear MM, Gupta AK, Rood JC, Ryan DH. Incremental weight loss improves cardiometabolic risk in extremely obese adults. Am J Med. 2011 Oct;124(10):931-8. doi: 10.1016/j.amjmed.2011.04.033.

  PMID: 21962313 BACKGROUND

MeSH Terms

Conditions

Obesity

Interventions

Erythritol

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Sugar Alcohols; Alcohols; Organic Chemicals; Carbohydrates

Study Officials

• Supawan Buranapin, MD

  Chiang Mai University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Supawan Buranapin, MD

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assisstant professor

Study Record Dates

• First Submitted: November 21, 2016
• First Posted: December 12, 2016
• Study Start: September 1, 2016
• Primary Completion: August 1, 2017
• Study Completion: November 1, 2017
• Last Updated: December 12, 2016

Record last verified: 2016-12

Data Sharing

• IPD Sharing: Will not share

Locations

TH (1)