Effect of D-allulose in Addition to Oral Sucrose Load
Condition: Blood Glucose
Study type: Interventional
Phase: Phase 2

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. 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.
    

Intervention name(s): D-allulose; sucrose; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement; Other
Intervention description(s): 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.; All subjects will receive a standardized oral sucrose load of 50 gms; 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.
Other intervention name(s): D-psicose
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: D-allulose; Caucasian; African American