Clinical Trials Logo

Clinical Trial Summary

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.


Clinical Trial Description

Observational research has linked intake of non-nutritive sweeteners (NNS), which are consumed daily by ~50% of middle-aged/older U.S. adults, with increased risk of type 2 diabetes (T2D). This risk may be exacerbated by advancing age, which is associated with low-grade chronic inflammation and increased risk of T2D. Current T2D prevention recommendations related to NNS usage are unclear and confusing; use as an alternative to added sugar intake is suggested but long-term NNS use is discouraged despite minimal research to support this recommendation. Animal and observational human studies suggest detrimental effects of some NNS on glucose homeostasis. Longer-term human studies largely demonstrate null findings. Differences in study design and a lack of rigor in existing research contribute to inconclusive findings. In addition, NNS are often studied as a single entity yet types of NNS vary in their absorption and metabolism (e.g., the two most commonly consumed NNS, sucralose and aspartame). 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. We will investigate changes in inflammatory markers as potential mechanisms by which sucralose intake influences glucose homeostasis. Following a 2-week eucaloric lead-in diet, 51 middle-aged/older adults (50+ yrs) with prediabetes will be randomly assigned to 1 of 3 controlled feeding conditions for 6 weeks (17 participants per group): sucralose, aspartame, or a control group (no NNS). Standardized diets will be matched for macronutrients (50% carbohydrate, 35% fat, 15% protein) and other variables to avoid the potential confounds of weight change and dietary factors which may influence study outcomes (e.g., added sugars). All groups will receive identical diets, other than the additional NNS for the two NNS groups. 24-hr glycemic control using continuous glucose monitoring and insulin sensitivity and beta cell function via oral glucose tolerance test (OGTT), serum endotoxin, and inflammatory cytokines, including C-reactive protein, will be measured before and following the 6-week dietary treatment period. This research may have clinical practice and policy implications by informing U.S. dietary guidelines and guidelines for T2D prevention, which devote minimal attention to NNS and provide unclear guidance on NNS use due largely to a lack of rigorously-designed controlled feeding trials. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05337098
Study type Interventional
Source Virginia Polytechnic Institute and State University
Contact Valisa Hedrick, PhD
Phone 540-231-7983
Email vhedrick@vt.edu
Status Recruiting
Phase N/A
Start date April 18, 2023
Completion date February 28, 2025

See also
  Status Clinical Trial Phase
Completed NCT03458741 - How is Glycogen Supercompensation Regulated in Human Skeletal Muscle N/A
Recruiting NCT06042517 - Mechanisms of Ultrasound Neuromodulation Effects in Diabetes N/A
Completed NCT03859934 - Metabolic Effects of Melatonin Treatment Phase 1
Completed NCT03689738 - Effects of Potato Resistant Starch Intake on Insulin Sensitivity, Related Metabolic Markers and Satiety N/A
Recruiting NCT04195165 - The Effect of Sitting and Moderate Exercise on Plasma Insulin and Glucose Responses to an Oral Glucose Tolerance Test N/A
Recruiting NCT05441982 - Saccharin and Acesulfame Potassium Consumption and Glucose Homeostasis in Older Adults With Prediabetes N/A
Terminated NCT03325933 - Resistance Training and Cardiometabolic Health N/A
Recruiting NCT05791968 - Blood Donation Could Improve Insulin Sensitivity N/A
Completed NCT02700698 - Mitochondrial Function in Circulating Cells and Muscle Tissue
Suspended NCT03240978 - Exercise Intervention for the Prevention of Prediabetes in Overweight Chinese N/A
Completed NCT02913079 - The Acute Impact of Sit-stand Desks on Post-meal Blood Sugar Levels N/A
Recruiting NCT01972113 - Vitamin K and Glucose Metabolism in Children at Risk for Diabetes (Vita-K 'n' Kids Study) N/A
Completed NCT02058914 - Effects of Sugar Sweetened Beverage on Metabolic Health in Male and Female Adolescents N/A
Enrolling by invitation NCT02192684 - Obesity, Sleep Apnea, and Insulin Resistance N/A
Completed NCT00936130 - Bariatric Surgery and Weight Loss on Energy Metabolism and Insulin Sensitivity N/A
Completed NCT01216956 - Metabolic Effects of an 8 Week Niaspan Treatment in Patients With Abdominal Obesity and Mixed Dyslipidemia N/A
Recruiting NCT05992688 - The Sweet Kids Study (Stevia on Weight and Energy Effect Over Time) N/A
Recruiting NCT04168372 - Fructose: Substrate, Stimulus, or Both? N/A
Recruiting NCT05443347 - Activity, Adiposity, and Appetite in Adolescents 2 Intervention N/A
Terminated NCT04239482 - Nutritional Supplementation and Insulin Sensitivity N/A