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Non-nutritive Sweetener

Non-Nutritive Sweetener Consumption for Prediabetes

N/A

Recruiting

Led By Valisa Hedrick, PhD

Research Sponsored by Virginia Polytechnic Institute and State University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Age 50+ years

Be older than 18 years old

Must not have

Antibiotic, prebiotic or prebiotic use in prior 3 months

Diagnosed inflammatory bowel disease

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6 weeks

Summary

This trial will study whether non-nutritive sweeteners (NNS) impact glucose homeostasis in middle-aged/older adults with prediabetes.

Who is the study for?

This trial is for middle-aged/older adults over 50 with prediabetes who are relatively inactive, willing to consume provided foods for 8 weeks, and have been weight stable. They should not be consuming much non-nutritive sweetener already (less than one serving per week), must not have plans to change their diet or exercise routine, and cannot be pregnant or planning pregnancy.

What is being tested?

The study investigates how the consumption of a non-nutritive sweetener called sucralose affects blood sugar control in older adults with prediabetes compared to aspartame and a regular diet without these sweeteners. The goal is to see if sucralose alters glucose levels differently than other options.

What are the potential side effects?

While specific side effects aren't listed for this trial, generally speaking, some people might experience digestive discomfort or changes in appetite when consuming non-nutritive sweeteners like sucralose.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 50 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have not taken antibiotics or pre/probiotics in the last 3 months.

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I have been diagnosed with inflammatory bowel disease.

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I have a history of heart, lung, blood, hormone, or cancer-related diseases.

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I am currently using estrogen or testosterone.

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My blood pressure is not higher than 159/99 mmHg.

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I have food allergies or PKU.

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I have diabetes or am taking medication for it.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~6 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

24-hour glycemic control

Secondary study objectives

C-reactive protein

Insulin Sensitivity

Interleukin 6

+4 more

Trial Design

3Treatment groups

Active Control

Placebo Group

Group I: SucraloseActive Control1 Intervention

Controlled feeding study. Dosage of sucralose will follow 50% of the acceptable daily intake (equivalent to 2.5 mg/kg for sucralose). This amount represents 150 mg/day of sucralose for a 60 kg adult.

Group II: AspartameActive Control1 Intervention

Controlled feeding study. Dosage of aspartame will follow 50% of the acceptable daily intake (equivalent to 25 mg/kg for aspartame). This amount represents 1,500 mg/day of aspartame for a 60 kg adult.

Group III: No NNSPlacebo Group1 Intervention

Controlled feeding study with no non-nutritive sweeteners.

0 / 8Eligibility criteria met