Effect of D-allulose in Addition to Oral Sucrose Load

Completed · Phase 2 · Has a placebo group

Conditions studied: Blood Glucose

In brief

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.

Key facts

Study ID

NCT02714413

Run by

University of Florida

People needed

50

Starts

2016-08-01

Expected to finish

2017-06-30

Last updated by the study team

2017-07-11

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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
• 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.

Where it is running

• University of Florida — Jacksonville, Florida, United States

Full record on ClinicalTrials.gov

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