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
- Conditions
- Allulosed-psicosepeople with type 2 diabetes mellitussweetenertype 2 diabetesglucose homeostasisMCP-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
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
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
Name Time Method glucose homeostasis at 12 weeks of allulose or aspartame consumption 75-gram oral glucose tolerance test
- Secondary Outcome Measures
Name Time Method 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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