ObesityNCT02988999
Efficacy of D-allulose on Weight and Fat Loss and Insulin Resistance in Non-diabetic Obese Subjects
A study testing D-allulose and erythritol in people with Obesity, run by Chiang Mai University at 1 site in Thailand.
Trial 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)… Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity
- What is being tested?
- D-allulose and erythritol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteThailand
- Study dates
- Sep 2016to Nov 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 12Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Thailand1 site, 1 recruiting
- Recruiting
Faculty of Medicine, Chiang Mai University
Muang Chiang Mai, Chiang Mai, 50200
Supawan Buranapin, MD
About this study
Official title: 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
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
Read more
- 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
Read the detailed 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
- Consume study product less than 90% during treatment period
- Start taking any medication that may affect body weight during in the study.
- Conditions
- Obesity
- Being tested
- D-allulose, erythritol
- Keywords
- D-allulose or erythritol
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
D-alluloseDietary 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.
erythritolDietary supplement
non-calorie sweetener
| Study group | Role | What they receive |
|---|---|---|
| D-allulose | Experimental | D-allulose 5 gm 3 times a day Receives: Dietary Supplement: D-allulose |
| erythritol | Active comparator | erythritol 5 gm 3 times a day Receives: Dietary Supplement: erythritol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Body composition change after 24 weeks of D-allulose consumption to erythritol consumption
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 28 weeks (assess 4 weeks after 24 weeks consumption of the study product)
Change in lipid profiles
Measured: 28 weeks (assess 4 weeks after 24 weeks consumption of the study product)
Changes on waist circumference, hip circumference
Measured: 28 weeks (assess 4 weeks after 24 weeks consumption of the study product)
Changes on waist/ hip ratio
Measured: 28 weeks (assess 4 weeks after 24 weeks consumption of the study product)
Adverse events by monitoring clinical and laboratory data
Measured: 28 weeks (assess 4 weeks after 24 weeks consumption of the study product)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2016 (estimated)
- Study startSep 2016
- Primary completionAug 2017 (estimated)
- Study completionNov 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (17)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chiang Mai University
- Sponsor type
- University, hospital or other
- Collaborators
- Kagawa University
- Responsible party
- Principal investigator, Supawan Buranapin, Chiang Mai University
- Investigators
- Supawan Buranapin, MD, Principal investigator, Chiang Mai University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02988999
- Sponsor's protocol ID
- CMU-D-allulose02
- Status last verified
- Dec 2016
- First submitted
- 21 Nov 2016
- Last updated
- 12 Dec 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
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.
PubMed 4299740Takeshita 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.
PubMed 16232889Granstrom 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.
PubMed 16233597Matsuo 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.
PubMed 12026195Matsuo 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.
PubMed 19794929Iida 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.
PubMed 19155592Hayashi 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.
PubMed 20208358Hossain 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.
PubMed 22877751Ochiai 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.
PubMed 24144428Matsuo 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.
PubMed 16960391Ochiai 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.
PubMed 23649241Chung 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.
PubMed 22339545Wong 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.
PubMed 16633129Haslam DW, James WP. Obesity. Lancet. 2005 Oct 1;366(9492):1197-209. doi: 10.1016/S0140-6736(05)67483-1.
PubMed 16198769The 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.
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT02988999
- Acronym / sponsor ID
- CMU-D-allulose02
- Conditions
- Obesity
- Keywords
- D-allulose or erythritol
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Chiang Mai UniversityUniversity, hospital or other
- Collaborators
- Kagawa University
- Study start
- Sep 2016
- Primary completion
- Aug 2017 (estimated)
- Study completion
- Nov 2017 (estimated)
- First posted
- 12 Dec 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed 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
- Consume study product less than 90% during treatment period
- Start taking any medication that may affect body weight during in the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| D-allulose | Experimental | Dietary Supplement: D-alluloseD-allulose 5 gm 3 times a day |
| erythritol | Active comparator | Dietary Supplement: erythritolerythritol 5 gm 3 times a day |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| D-alluloseD-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 | D-allulose |
| erythritolnon-calorie sweetener | Dietary supplement | erythritol |
Primary outcome
Body composition change after 24 weeks of D-allulose consumption to erythritol consumption
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 28 weeks (assess 4 weeks after 24 weeks consumption of the study product)
8 secondary outcomes
insulin resistance change (as calculated from HOMA-IR) after 24 weeks of D-allulose consumption to erythritol consumption
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 28 weeks (assess 4 weeks after 24 weeks consumption of the study product)
Change in lipid profiles
Time frame: 28 weeks (assess 4 weeks after 24 weeks consumption of the study product)
Changes on waist circumference, hip circumference
Time frame: 28 weeks (assess 4 weeks after 24 weeks consumption of the study product)
Changes on waist/ hip ratio
Time frame: 28 weeks (assess 4 weeks after 24 weeks consumption of the study product)
Adverse events by monitoring clinical and laboratory data
Time frame: 28 weeks (assess 4 weeks after 24 weeks consumption of the study product)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Dec 2016.
- Background: PubMed 4299740Cree 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.
- Background: PubMed 16232889Takeshita 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.
- Background: PubMed 16233597Granstrom 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.
- Background: PubMed 12026195Matsuo 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.
- Background: PubMed 19794929Matsuo 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.
- Background: PubMed 19155592Iida 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.
- Background: PubMed 20208358Hayashi 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.
- Background: PubMed 22877751Hossain 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.
- Background: PubMed 24144428Ochiai 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.
- Background: PubMed 16960391Matsuo 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.
- Background: PubMed 23649241Ochiai 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.
- Background: PubMed 22339545Chung 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.
- Individual participant dataSharing planned: No
Related trials for Obesity
RecruitingObservational study
Endoscopic Sleeve Gastroplasty (ESG) Prospective Trial for Obesity (EGO-Trial)
Obesity
Active, not recruitingPhase 4
Effects of Sequential Therapy With Mexidol® (Intravenous) and Mexidol® FORTE 250 (Oral) on Functional Brain Activity Assessed by Functional Magnetic Resonance Imaging and Biochemical Parameters in Patients With Chronic Cerebral Ischemia: A Comparison of Patients With and Without Metabolic Disorders
Metabolic Abnormalities, Obesity & Overweight
Recruiting
Exercise Training and Vitamin D Metabolism
Obesity & Overweight, Vitamin D
Recruiting
Metabolic Health, Bones and Nuts During Weight Loss in Adults
Weight Loss, Bone Density
Active, not recruiting
Effect of Probiotics on Insulin Sensitivity in Overweight and Obese Pregnancy
Obesity & Overweight, Gestational Diabetes Mellitus (GDM)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Supawan Buranapin, MD principal investigator
Chiang Mai University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing D-allulose and erythritol in people with Obesity, run by Chiang Mai University at 1 site in Thailand.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 Dec 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Supawan Buranapin, MD (66-867310392, supawan.b@cmu.ac.th), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Body composition change after 24 weeks of D-allulose consumption to erythritol consumption (time frame: 28 weeks (assess 4 weeks after 24 weeks consumption of the study product)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02988999, which also lists 17 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Dec 2016.