NCT02714413

Effect of D-allulose in Addition to Oral Sucrose Load

Effect of D-allulose Ingestion on the Glucose and Insulin Response to a Standardized Oral Sucrose Load

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 50 (actual)
• Sponsor: University of Florida · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Accepted

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.

Conditions

• Blood Glucose

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	D-allulose	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.
DIETARY_SUPPLEMENT	sucrose	All subjects will receive a standardized oral sucrose load of 50 gms
OTHER	Placebo	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.

Timeline

• Start date: 2016-08-01
• Primary completion: 2017-03-10
• Completion: 2017-06-30
• First posted: 2016-03-21
• Last updated: 2017-07-11

Locations

1 site across 1 country: United States