Blood GlucosePhase 2NCT02714413
Effect of D-allulose in Addition to Oral Sucrose Load
A Phase 2 study testing D-allulose and sucrose in people with Blood Glucose, run by University of Florida at 1 site in United States.
Trial summary
Individuals in the United States now consume a substantial proportion of their total energy as added sugars. The consumption of caloric sweeteners has been steadily increasing over the last four decades. The potential health consequences of this practice have been subject to considerable debate. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Blood Glucose
- What is being tested?
- D-allulose and sucrose
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2016to 30 Jun 2017
- Phase
- Phase 2
- 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 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Men or women 18-70 years of age
- Have an HbA1C < 5.8%.
- Subjects from whom informed consent has been obtained in accordance with University of Florida Institutional Review Board regulations.
Who cannot join
- 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
Show all 27Show fewer
- 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
- People with clinical diagnosis of diabetes.
- Patients in cardiac Class II, III or IV.
- Patients who have had renal transplants or are currently receiving renal dialysis.
- Patients with the diagnosis of psychosis.
- Patients with known HIV infection.
- Patients with history of malignancy within the last one year with the exception of localized skin cancers.
- Patients with significant clinical signs or symptoms of liver disease, acute or chronic hepatitis, or aspartate transaminase (AST or SGOT) greater than three times the upper reference range limit.
- Patients with clinical signs or symptoms of drug or alcohol abuse.
- Patients with a life expectancy of less than 5 years.
- Patients with any cognitive impairment diagnosed previously
- Patients with a serum creatinine greater 1.5 mg/dl.
- Patients exhibiting serious non-compliance with prescribed diet or drug therapy.
- Patients who are currently participating or have participated in a medical, surgical, or pharmaceutical investigation in which an investigational new drug was dispensed to the patient within the last 30 days months.
- Patients with a body mass index (B.M.I.) greater than 40 kg/m2.
- Patients with a body mass index (B.M.I.) less than 20 kg/m2.
- Any situation which precludes the patient from following and completing the protocol.
- Patients with known hemoglobinopathy or chronic anemia with hemoglobin <10gm/dL.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of D-allulose Ingestion on the Glucose and Insulin Response to a Standardized Oral Sucrose Load
Individuals in the United States now consume a substantial proportion of their total energy as added sugars. The consumption of caloric sweeteners has been steadily increasing over the last four decades. The potential health consequences of this practice have been subject to considerable debate. In addition to weight gain, higher consumption of sugar-sweetened beverages is associated with development of metabolic syndrome and type 2 diabetes. These findings support the current dietary guidelines that encourage consumers to limit their intake of added sugars. There is a need for a sugar substitute that is safe, palatable and has favorable effects on energy metabolism and overall glucose homeostasis. One such sugar is possibly D-allulose also referred to in the literature as D-psicose. The present proposal is to address the efficacy of D-allulose in reducing postprandial blood glucose level in a random sample of Caucasian and African American population. Specifically the effect of D-allulose ingestion on the glucose and insulin response to a standardized oral glucose load will be studied.
Read the detailed description
Individuals in the United States now consume a substantial proportion of their total energy as added sugars. The consumption of caloric sweeteners has been steadily increasing over the last four decades. The potential health consequences of this practice have been subject to considerable debate. In a prospective follow-up study of 43,960 African American women who gave complete dietary and weight information and were free from diabetes at baseline, the incidence of type 2 diabetes mellitus was higher with higher intake of both sugar-sweetened soft drinks and fruit drinks. Similar conclusions were drawn in a meta- analysis of 11 studies of consumption of sugar-sweetened beverages in relation to risk of metabolic syndrome and type 2 diabetes. Thus, in addition to weight gain, higher consumption of sugar-sweetened beverages is associated with development of metabolic syndrome and type 2 diabetes. These findings support the current dietary guidelines that encourage consumers to limit their intake of added sugars. There is a need for a sugar substitute that is safe, palatable and has favorable effects on energy metabolism and overall glucose homeostasis. One such sugar is possibly D-allulose also referred to in the literature as D-psicose. D-allulose is a non-calorie monosaccharide which has approximately 70% sweetness of sucrose. Early clinical trials of D-allulose demonstrating its anti-diabetic and anti-obesity effects have been carried out in Kagawa (Japan). As of to date, there are still insufficient data to confirm the efficacy of pure D-allulose in Caucasian or African American populations. The present proposal is to address the efficacy of D-allulose in reducing postprandial blood glucose level in a random sample of Caucasian and African American population. This is a single center, prospective, randomized, double-blind, placebo-controlled crossover study evaluating the efficacy of pure D-allulose in Caucasian and African American populations. Subjects will be their own controls as they will be studied sequentially for the effects of varying amounts of D-allulose given in a random order on glycemic and insulin excursions associated with standardized oral sucrose load of 50 gms.
- Conditions
- Blood Glucose
- Being tested
- D-allulose, sucrose, Placebo
- Keywords
- D-allulose, Caucasian, African American
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
D-alluloseDietary supplement
Also called D-psicose
Subjects will be their own controls as they will be studied sequentially for the effects of varying amounts of D-allulose given in a random order associated with standardized oral sucrose load of 50 gms. In order to limit the possibility of carry-over effect, patients will be randomized to different treatment sequences. In each sequence all four doses (2.5, 5, 7.5, and 10 gm) and placebo will be present only one time and will be administered in a different order.
sucroseDietary supplement
All subjects will receive a standardized oral sucrose load of 50 gms
PlaceboOther
Subjects will be their own controls as they will be studied sequentially for the effects of varying amounts of D-allulose given in a random order associated with standardized oral sucrose load of 50 gms. In order to limit the possibility of carry-over effect, patients will be randomized to different treatment sequences. In each sequence all four doses (2.5, 5, 7.5, and 10 gm) and placebo will be present only one time and will be administered in a different order.
| Study group | Role | What they receive |
|---|---|---|
| Sucrose 50g + placebo | Placebo comparator | All the test sugars will be dissolved in 300 ml water to be consumed within 10 minutes Receives: Dietary Supplement: sucrose; Other: Placebo |
| Sucrose 50g + D-allulose 2.5 g | Experimental | All the test sugars will be dissolved in 300 ml water to be consumed within 10 minutes Receives: Dietary Supplement: D-allulose; Dietary Supplement: sucrose |
| Sucrose 50g + D-allulose 5.0 g | Experimental | All the test sugars will be dissolved in 300 ml water to be consumed within 10 minutes Receives: Dietary Supplement: D-allulose; Dietary Supplement: sucrose |
| Sucrose 50g + D-allulose 7.5 g | Experimental | All the test sugars will be dissolved in 300 ml water to be consumed within 10 minutes Receives: Dietary Supplement: D-allulose; Dietary Supplement: sucrose |
| Sucrose 50g + D-allulose10.0 g | Experimental | All the test sugars will be dissolved in 300 ml water to be consumed within 10 minutes Receives: Dietary Supplement: D-allulose; Dietary Supplement: sucrose |
What is being measured
The primary outcome is the main question the study is designed to answer.
Plasma glucose (mg/dL)
Evaluation of the efficacy of pure D-allulose on the glycemic excursion following a standard oral sucrose load.
Measured: 120 minutes
Secondary outcomes (1)
Serum insulin
Evaluation of the efficacy of pure D-allulose on the elevation of serum insulin following ingestion of a standard oral sucrose load
Measured: 120 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2016 (estimated)
- Study startAug 2016
- Primary completion10 Mar 2017
- Study completion30 Jun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Blood GlucoseStudies of the same condition, open and under way.
- More trials run by University of FloridaThe sponsor's other registered studies.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Florida
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Dominick J Angiolillo, MD, PhD, Principal investigator, University of Florida College of Medicine-Jacksonville
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02714413
- Sponsor's protocol ID
- IIS-Allulose-16
- Status last verified
- Jul 2017
- First submitted
- 8 Mar 2016
- Last updated
- 11 Jul 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Franchi F, Yaranov DM, Rollini F, Rivas A, Rivas Rios J, Been L, Tani Y, Tokuda M, Iida T, Hayashi N, Angiolillo DJ, Mooradian AD. Effects of D-allulose on glucose tolerance and insulin response to a standard oral sucrose load: results of a prospective, randomized, crossover study. BMJ Open Diabetes Res Care. 2021 Feb;9(1):e001939. doi: 10.1136/bmjdrc-2020-001939.
PubMed 33637605
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of D-allulose Ingestion on the Glucose and Insulin Response to a Standardized Oral Sucrose Load
- ClinicalTrials.gov ID
- NCT02714413
- Acronym / sponsor ID
- IIS-Allulose-16
- Conditions
- Blood Glucose
- Keywords
- D-allulose, Caucasian, African American
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- University of FloridaUniversity, hospital or other
- Study start
- Aug 2016 (actual)
- Primary completion
- 10 Mar 2017 (actual)
- Study completion
- 30 Jun 2017 (actual)
- First posted
- 21 Mar 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.
Individuals in the United States now consume a substantial proportion of their total energy as added sugars. The consumption of caloric sweeteners has been steadily increasing over the last four decades. The potential health consequences of this practice have been subject to considerable debate. In addition to weight gain, higher consumption of sugar-sweetened beverages is associated with development of metabolic syndrome and type 2 diabetes. These findings support the current dietary guidelines that encourage consumers to limit their intake of added sugars. There is a need for a sugar substitute that is safe, palatable and has favorable effects on energy metabolism and overall glucose homeostasis. One such sugar is possibly D-allulose also referred to in the literature as D-psicose. The present proposal is to address the efficacy of D-allulose in reducing postprandial blood glucose level in a random sample of Caucasian and African American population. Specifically the effect of D-allulose ingestion on the glucose and insulin response to a standardized oral glucose load will be studied.
Detailed description
Individuals in the United States now consume a substantial proportion of their total energy as added sugars. The consumption of caloric sweeteners has been steadily increasing over the last four decades. The potential health consequences of this practice have been subject to considerable debate. In a prospective follow-up study of 43,960 African American women who gave complete dietary and weight information and were free from diabetes at baseline, the incidence of type 2 diabetes mellitus was higher with higher intake of both sugar-sweetened soft drinks and fruit drinks. Similar conclusions were drawn in a meta- analysis of 11 studies of consumption of sugar-sweetened beverages in relation to risk of metabolic syndrome and type 2 diabetes. Thus, in addition to weight gain, higher consumption of sugar-sweetened beverages is associated with development of metabolic syndrome and type 2 diabetes. These findings support the current dietary guidelines that encourage consumers to limit their intake of added sugars. There is a need for a sugar substitute that is safe, palatable and has favorable effects on energy metabolism and overall glucose homeostasis. One such sugar is possibly D-allulose also referred to in the literature as D-psicose. D-allulose is a non-calorie monosaccharide which has approximately 70% sweetness of sucrose. Early clinical trials of D-allulose demonstrating its anti-diabetic and anti-obesity effects have been carried out in Kagawa (Japan). As of to date, there are still insufficient data to confirm the efficacy of pure D-allulose in Caucasian or African American populations. The present proposal is to address the efficacy of D-allulose in reducing postprandial blood glucose level in a random sample of Caucasian and African American population. This is a single center, prospective, randomized, double-blind, placebo-controlled crossover study evaluating the efficacy of pure D-allulose in Caucasian and African American populations. Subjects will be their own controls as they will be studied sequentially for the effects of varying amounts of D-allulose given in a random order on glycemic and insulin excursions associated with standardized oral sucrose load of 50 gms.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Sucrose 50g + placebo | Placebo comparator | Dietary Supplement: sucrose, Other: PlaceboAll the test sugars will be dissolved in 300 ml water to be consumed within 10 minutes |
| Sucrose 50g + D-allulose 2.5 g | Experimental | Dietary Supplement: D-allulose, Dietary Supplement: sucroseAll the test sugars will be dissolved in 300 ml water to be consumed within 10 minutes |
| Sucrose 50g + D-allulose 5.0 g | Experimental | Dietary Supplement: D-allulose, Dietary Supplement: sucroseAll the test sugars will be dissolved in 300 ml water to be consumed within 10 minutes |
| Sucrose 50g + D-allulose 7.5 g | Experimental | Dietary Supplement: D-allulose, Dietary Supplement: sucroseAll the test sugars will be dissolved in 300 ml water to be consumed within 10 minutes |
| Sucrose 50g + D-allulose10.0 g | Experimental | Dietary Supplement: D-allulose, Dietary Supplement: sucroseAll the test sugars will be dissolved in 300 ml water to be consumed within 10 minutes |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Men or women 18-70 years of age
- Have an HbA1C < 5.8%.
- Subjects from whom informed consent has been obtained in accordance with University of Florida Institutional Review Board regulations.
Key exclusion criteria (27 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-alluloseAlso: D-psicoseSubjects will be their own controls as they will be studied sequentially for the effects of varying amounts of D-allulose given in a random order associated with standardized oral sucrose load of 50 gms. In order to limit the possibility of carry-over effect, patients will be randomized to different treatment sequences. In each sequence all four doses (2.5, 5, 7.5, and 10 gm) and placebo will be present only one time and will be administered in a different order. | Dietary supplement | Sucrose 50g + D-allulose 2.5 g, Sucrose 50g + D-allulose 5.0 g, Sucrose 50g + D-allulose 7.5 g, Sucrose 50g + D-allulose10.0 g |
| sucroseAll subjects will receive a standardized oral sucrose load of 50 gms | Dietary supplement | Sucrose 50g + D-allulose 2.5 g, Sucrose 50g + D-allulose 5.0 g, Sucrose 50g + D-allulose 7.5 g, Sucrose 50g + D-allulose10.0 g, Sucrose 50g + placebo |
| PlaceboSubjects will be their own controls as they will be studied sequentially for the effects of varying amounts of D-allulose given in a random order associated with standardized oral sucrose load of 50 gms. In order to limit the possibility of carry-over effect, patients will be randomized to different treatment sequences. In each sequence all four doses (2.5, 5, 7.5, and 10 gm) and placebo will be present only one time and will be administered in a different order. | Other | Sucrose 50g + placebo |
Primary outcome
Plasma glucose (mg/dL)
Time frame: 120 minutes
Evaluation of the efficacy of pure D-allulose on the glycemic excursion following a standard oral sucrose load.
1 secondary outcome
Serum insulin
Time frame: 120 minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jul 2017.
- Derived from this study: PubMed 33637605Franchi F, Yaranov DM, Rollini F, Rivas A, Rivas Rios J, Been L, Tani Y, Tokuda M, Iida T, Hayashi N, Angiolillo DJ, Mooradian AD. Effects of D-allulose on glucose tolerance and insulin response to a standard oral sucrose load: results of a prospective, randomized, crossover study. BMJ Open Diabetes Res Care. 2021 Feb;9(1):e001939. doi: 10.1136/bmjdrc-2020-001939.
- Individual participant dataSharing planned: No
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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.
Dominick J Angiolillo, MD, PhD principal investigator
University of Florida College of Medicine-Jacksonville
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing D-allulose and sucrose in people with Blood Glucose, run by University of Florida at 1 site in United States.
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 3 inclusion and 27 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: finished, as of the sponsor's last update on 11 Jul 2017. 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 United States. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Plasma glucose (mg/dL) (time frame: 120 minutes). 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 NCT02714413, which also lists 1 linked publication.
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 11 Jul 2017.