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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05337098
Other study ID # 1R21AG075344-01
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date April 18, 2023
Est. completion date February 28, 2025

Study information

Verified date April 2024
Source Virginia Polytechnic Institute and State University
Contact Valisa Hedrick, PhD
Phone 540-231-7983
Email vhedrick@vt.edu
Is FDA regulated No
Health authority
Study type Interventional

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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 51
Est. completion date February 28, 2025
Est. primary completion date February 28, 2025
Accepts healthy volunteers No
Gender All
Age group 50 Years and older
Eligibility Inclusion Criteria: - Age 50+ 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 - Sedentary to recreationally active - No plans to gain/lose weight or change physical activity level - Willing to pick up food daily and consume foods provided for an 8-week period - Verbal and written informed consent - Approval by Medical Director - Consume less than one serving of non-nutritive sweetener per week Exclusion Criteria: - 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) - Diagnosed inflammatory bowel disease - Past or current heart diseases, stroke, respiratory disease, endocrine or metabolic disease, or hematological-oncological disease - Vegetarian or vegan - Pregnant or plans to become pregnant - Breastfeeding - Food allergies or aversions, Phenylketonuria (PKU) - Estrogen or testosterone usage

Study Design


Intervention

Other:
Non-Nutritive Sweetener Intake and impact on glucose homeostasis
Provision of either aspartame, sucralose, or control with no non-nutritive sweeteners to a controlled feeding study to determine impacts on glucose homeostasis.

Locations

Country Name City State
United States Virginia Tech Blacksburg Virginia

Sponsors (1)

Lead Sponsor Collaborator
Virginia Polytechnic Institute and State University

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 6 weeks
Secondary 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 6 weeks
Secondary Insulin Sensitivity Insulin uU/mL concentrations from the oral glucose tolerance test at baseline and follow-up will be used 6 weeks
Secondary Serum Endotoxin Serum endotoxin mg/L concentrations will be measured at baseline and follow-up 6 weeks
Secondary C-reactive protein C-reactive protein mg/dL concentrations will be measured at baseline and follow-up 6 weeks
Secondary Tumor Necrosis Factor alpha Inflammatory cytokine: Tumor Necrosis Factor alpha pg/mL concentrations will be measured at baseline and follow-up 6 weeks
Secondary Interleukin 6 Inflammatory cytokine: Interleukin 6 pg/mL concentrations will be measured at baseline and follow-up 6 weeks
Secondary Monocyte chemoattractant protein-1 Inflammatory cytokine: Monocyte chemoattractant protein-1 pg/mL concentrations will be measured at baseline and follow-up 6 weeks
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