Non-Nutritive Sweetener Consumption and Glucose Homeostasis in Older Adults With Prediabetes

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age40+
SponsorVirginia Polytechnic Institute and State University

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 volunteers

Qualifiers

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

Design model

Parallel

Treatments tested in this trial

  • Non-Nutritive Sweetener Intake and impact on glucose homeostasis

    Other intervention

    Provision of either aspartame, sucralose, or control with no non-nutritive sweeteners to a controlled feeding study to determine impacts on glucose homeostasis.

Treatment groups

30 Participants
are divided into 3 treatment groups
Group A: AspartameActive comparator 1 intervention
Group B: SucraloseActive comparator 1 intervention
Group C: No NNSSham comparator 1 intervention

Trial outcomes

Primary outcomes

1

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

Time frame
6 weeks

Secondary outcomes

1

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

Time frame
6 weeks
2

Insulin Sensitivity

Insulin uU/mL concentrations from the oral glucose tolerance test at baseline and follow-up will be used

Time frame
6 weeks
3

Serum Endotoxin

Serum endotoxin mg/L concentrations will be measured at baseline and follow-up

Time frame
6 weeks
4

C-reactive protein

C-reactive protein mg/dL concentrations will be measured at baseline and follow-up

Time frame
6 weeks

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.