About this trial
Animal and observational research in humans suggest that specific types of non-nutritive sweeteners (NNS) may impair glycemic control. However, whether NNS consumption impacts glucose homeostasis in middle-aged/older adults with prediabetes is unknown, and potential mechanisms by which this could occur have yet to be identified. The overall objective of this R21 proposal is to establish proof-of-concept for alterations in glucose homeostasis following intake of sucralose, but not aspartame, in middle-aged/older adults with prediabetes compared to a eucaloric diet with no NNS.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age 40+ years
Prediabetic (fasting glucose concentration of 100-125 mg/dL, 2-hour oral glucose tolerance test glucose concentration of 140-199 mg/dL, or a HbA1c value of 5.7% to 6.4%)
Weight stable for previous 6 months (±2 kg)
BMI <40 kg/m2
Disqualifiers
BMI >40 kg/m2
Diabetes or diabetes medication
Antibiotic, prebiotic or prebiotic use in prior 3 months
Uncontrolled hypertension (blood pressure (BP) > 159/99 mmHg)
Trial design
Parallel
Treatments tested in this trial
Non-Nutritive Sweetener Intake and impact on glucose homeostasis
Other interventionProvision of either aspartame, sucralose, or control with no non-nutritive sweeteners to a controlled feeding study to determine impacts on glucose homeostasis.
Treatment groups
Trial outcomes
Primary outcomes
24-hour glycemic control
The area under the curve (AUC) glucose concentrations, mg/dl from the continuous glucose monitoring at baseline and follow-up will be used
Secondary outcomes
Oral glucose tolerance
Oral glucose tolerance in response to 75 g glucose load; levels of glucose mg/dl will be determined 2 hrs after consuming a 75 glucose load
Insulin Sensitivity
Insulin uU/mL concentrations from the oral glucose tolerance test at baseline and follow-up will be used
Serum Endotoxin
Serum endotoxin mg/L concentrations will be measured at baseline and follow-up
C-reactive protein
C-reactive protein mg/dL concentrations will be measured at baseline and follow-up
Sponsors and contacts
Click on the lead sponsor to view all of their trials.