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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 weeks
Awards & highlights
Study 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.Check my eligibility
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.See study design
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 belowSelect...
I am 50 years old or older.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 6 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
24-hour glycemic control
Secondary outcome measures
C-reactive protein
Insulin Sensitivity
Interleukin 6
+4 moreTrial 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.
Find a Location
Who is running the clinical trial?
Virginia Polytechnic Institute and State UniversityLead Sponsor
142 Previous Clinical Trials
27,755 Total Patients Enrolled
Valisa Hedrick, PhDPrincipal InvestigatorVirginia Polytechnic Institute and State University
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- Your body mass index (BMI) is less than 40.You are not planning to change your weight or how much you exercise.My blood pressure is not higher than 159/99 mmHg.I have a history of heart, lung, blood, hormone, or cancer-related diseases.You eat less than one serving of artificial sweetener per week.I have food allergies or PKU.You are a vegetarian or vegan.Your body mass index is higher than 40.Your weight has stayed about the same for the past 6 months, give or take 2 kilograms.Your blood sugar levels show that you are at risk of developing diabetes.I have been diagnosed with inflammatory bowel disease.I have diabetes or am taking medication for it.I am currently using estrogen or testosterone.I am not very active or only exercise occasionally.I have not taken antibiotics or pre/probiotics in the last 3 months.I am 50 years old or older.
Research Study Groups:
This trial has the following groups:- Group 1: Sucralose
- Group 2: Aspartame
- Group 3: No NNS
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How many individuals are being recruited to participate in this study?
"Affirmative, according to the clinicaltrials.gov records, this research project is still gathering participants. It was first uploaded on January 15th 2023 and last updated on October 13th 2022. The investigation requires 51 individuals at one site for participation."
Answered by AI
Are there any remaining spots for participants in this experiment?
"Affirmative. Clinicaltrials.gov indicates that this research project, which was first posted on January 15th 2023, is currently seeking participants. 51 volunteers must be recruited from a single medical centre."
Answered by AI
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