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ong-Term Effects of Allulose Consumption on Glucose Ho-meostasis, Metabolic Parameters, Incretin Levels, and Inflam-matory Markers in Patients with Type 2 Diabetes: A Dou-ble-Blind, Randomized, Controlled Crossover Clinical Trial

Phase 2
Completed
Conditions
Allulose
d-psicose
people with type 2 diabetes mellitus
sweetener
type 2 diabetes
glucose homeostasis
MCP-1
Registration Number
TCTR20220516006
Lead Sponsor
the Innovation and Technology Assistance Program (ITAP) of the National Science and Technology Development Agency (NSTDA)
Brief Summary

Twelve weeks allulose consumption resulted in neutral effect on glucose homeostasis, body composition, incretin levels, transient decreased high-density lipoprotein cholesterol level, and increased MCP-1 level.

Detailed Description

Not available

Recruitment & Eligibility

Status
Completed
Sex
All
Target Recruitment
16
Inclusion Criteria

1. diagnosis of T2D
2. being treated with metformin monotherapy or lifestyle modification
3. a glycated hemoglobin (HbA1c) of <8%
4. not having consumed artificial sweetener for at least 2 weeks

Exclusion Criteria

1. chronic kidney disease (CKD) (estimated glomerular filtration rate [eGFR] <60 ml/min/m2)
2. aminotransferase >3 times the upper limit of normal range
3. severe illness
4. phenylke-tonuria
5. pregnant or breastfeeding
6. taking medication that affects glycemic con-trol (e.g., steroid, estrogen, androgen)

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
glucose homeostasis at 12 weeks of allulose or aspartame consumption 75-gram oral glucose tolerance test
Secondary Outcome Measures
NameTimeMethod
HbA1c, lipid profile, GLP1, GIP, TNF-alpha, MCP-1 at 12 weeks of allulose or aspartame consumption venous blood sample,body composition at 12 weeks of allulose or aspartame consumption energy X-ray absorptiometry , bioelectrical impedance analysis
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