- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03944616
Study Of Drinks With Artificial Sweeteners in People With Type 2 Diabetes (SODAS)
April 28, 2023 updated by: Andrew Odegaard, University of California, Irvine
Effect of Artificially Sweetened Beverages on Diabetes Control in Adults With Type 2 Diabetes
Diet beverages sweetened with artificial sweeteners occupy a unique category in the food environment as they are a source of intensely sweet taste with no calories.
Diet beverages are the single largest contributor to artificial sweetener intake in the U.S. diet, and people with diabetes are the highest consumers of diet beverages, tending to consume them as a replacement for dietary sources of sugar, especially in place of sugar-sweetened beverages.
This behavior has been endorsed by dietetic and scientific organizations, and diet beverages are marketed as being synonymous with better health, suitable for weight loss, and thus advantageous for diabetes control.
The underlying public health concern is that there are few data to support or refute the benefit or harm of habitual diet beverage consumption by people with diabetes; therefore randomized trials with relevant outcomes must be conducted because they would address many limitations of previous research and have major implications for dietary recommendations on diet beverage intake and primary and secondary prevention of chronic disease.
To begin addressing this important scientific gap the investigators are testing the effect of diet beverage intake on diabetes control parameters in free-living adults with type 2 diabetes in a randomized, two arm parallel trial with a run-in period of 2-weeks and an active intervention period of 24-weeks.
This study will recruit 200 patients with type 2 diabetes who are usual consumers of commercial diet beverages and randomize them to receive and consume either: 1) A commercial diet beverage of choice (3 servings or 24 oz.
daily); or 2) Unflavored bottled water of choice (sparkling or plain) (3 servings or 24 oz.
daily).
The primary outcome will be a central measure of clinical diabetes control in glycated hemoglobin (HbA1c).
The study will also measure the nature and magnitude of glycemic excursions via continuous glucose monitors, as well as clinical markers of cardiometabolic risk and kidney function.
Lastly, investigators will measure plausible mechanisms whereby diet beverage intake may alter risk by assessing the effect of diet beverage intake on the functional composition of the gut microbiome via stool samples and comprehensive metabolomics, satiety hormones, as well as usual dietary intake, and upstream behavioral pathways which may inform dietary intake patterns.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
181
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
California
-
Irvine, California, United States, 92697
- University of California, Irvine
-
-
Minnesota
-
Minneapolis, Minnesota, United States, 55454
- University of Minnesota
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
33 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
Inclusion criteria: We will include men, women and non-binary participants with T2D, age 35 years and older, able to provide informed consent, otherwise healthy, who meet the following criteria:
- Physician diagnosed type 2 diabetes ≥ 6 months prior to screening
- HbA1c 6.5-8.5% at participant screening
- Current treatment with lifestyle changes or stable diabetes-related medication levels for the past 3 months
- Willingness to provide consent to contact treating physician and physician agreement to refrain from changing diabetes-related medications during the trial (change defined as > 2 fold change in dose of any 1 hyperglycemic agent or addition or subtraction of an agent)
- No physician-directed medication change for 3 months if prescribed medication for lipids or blood pressure
- Usual consumers of diet beverages (≥ 3 servings/ week (24 oz.) and the willingness to maintain fidelity of the intervention, and participate in all aspects of the intervention
- Not actively looking to make major lifestyle alterations during the study period with stable weight for 2 months (within 3%).
Exclusion Criteria:
- Type 1 diabetes or suspected type 1 diabetes (lean with polyuria, polydipsia, and weight loss with little response to metformin)
- "Secondary" diabetes due to specific causes (e.g. monogenic syndromes, pancreatic surgery, and pancreatitis)
- Diabetic Ketoacidosis hospitalization within last 6 months
- Severe/major hypoglycemia in the last 3 months-severe/major hypoglycemia is defined as a hypoglycemic event in which patient requires assistance of another person to manage the episode
- Glucocorticoid use (prednisone 2.5 mg/d or more or its equivalent)
- History of intolerance or allergy to diet beverages or AS or phenylketonuria
- Any condition that is known to affect the validity of the glycemic measures (Hba1c)
- Major cardiovascular disease event or surgery within past 6 months
- Gastrointestinal disease
- Renal or liver disease
- Current treatment for cancer
- Those with major surgery planned or history of bariatric surgery
- Antibiotic treatment (> 6 days) within past 6 months
- Currently pregnant (via self-report) or planning to become pregnant during study period; <1 year postpartum and breast feeding
- Current participation in another interventional clinical trial
- Previous randomization in this study,
- Heavy alcohol consumption (on average >2 drinks/day for women and >3 drinks/day for men)
- Habitual consumer of SSB ≥ 1 serving / day (8 oz.)
- Does not drink diet beverages
- BMI < 20.0 kg/m2
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Diet Beverage
Participants will receive and consume three daily servings (24 ounces) of a non-caloric commercial diet beverage of their choice sweetened with FDA approved artificial sweeteners.
|
Participants will receive and consume three daily servings (24 ounces) of a non-caloric commercial diet beverage of their choice sweetened with FDA approved artificial sweeteners.
|
Experimental: Water
Participants will receive and consume three daily servings (24 ounces) of plain bottled/canned water in place of their usual commercial diet beverage.
The water will be unflavored, unsweetened, non-caloric, and may be plain or sparkling.
Participants randomized to consume water will be instructed to avoid intake of diet beverages.
|
Participants will receive and consume three daily servings (24 ounces) of plain bottled/canned water in place of their usual commercial diet beverage.
The water will be unflavored, unsweetened, non-caloric, and may be plain or sparkling.
Participants randomized to consume water will be instructed to avoid intake of diet beverages.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
HbA1c
Time Frame: 0, 12, 24 weeks
|
Glycated hemoglobin
|
0, 12, 24 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Time In Range
Time Frame: All 14 day periods: Run-in (2-weeks, usual-baseline), weeks 11 and 12 (14 days), weeks 23 and 24 (14 days)
|
Time in range is collected by a masked Continuous Glucose Monitor (CGM), which measures individual glucose levels every 15 minutes for two weeks via a sensor placed on the participants upper arm (underside).
Time in Range is defined as the % of time each day with a glucose measure between 70-180 mg/dl.
The range of CGM data for inclusion in this study will be 5 to 14 days, consistent with manufacturer's recommendations.
|
All 14 day periods: Run-in (2-weeks, usual-baseline), weeks 11 and 12 (14 days), weeks 23 and 24 (14 days)
|
Glycemic Variability
Time Frame: All 14 day periods: Run-in (2-weeks, usual-baseline), weeks 11 and 12 (14 days), weeks 23 and 24 (14 days)
|
Glycemic variability is collected by a masked Continuous Glucose Monitor (CGM), which measures individual glucose levels every 15 minutes for two weeks via a sensor placed on the participants upper arm (underside).
Glycemic variability is defined as the CV and SD.
The range of CGM data for inclusion in this study will be 5 to 14 days, consistent with manufacturer's recommendations.
|
All 14 day periods: Run-in (2-weeks, usual-baseline), weeks 11 and 12 (14 days), weeks 23 and 24 (14 days)
|
Other CGM metrics
Time Frame: All 14 day periods: Run-in (2-weeks, usual-baseline), weeks 11 and 12 (14 days), weeks 23 and 24 (14 days)
|
Multiple metrics are able to be calculated by CGM.
The primary secondary endpoint for CGM will be Time In Range.
Reporting of any other CGM metrics will be prefaced with this statement and the residual CGM metrics will be analyzed and interpreted cautiously and conservatively.
They include: Mean glucose, glycemic variability, and episodes of hypoglycemia/hyperglycemia.
|
All 14 day periods: Run-in (2-weeks, usual-baseline), weeks 11 and 12 (14 days), weeks 23 and 24 (14 days)
|
Lipid panel (Total cholesterol, LDL cholesterol, HDL cholesterol, Fasting Triglycerides), all mg/dL
Time Frame: 0, 12, 24 weeks
|
A lipid panel is a standard measurement for assessing clinical CVD risk
|
0, 12, 24 weeks
|
Kidney function
Time Frame: 0, 6, 12, 18, 24 weeks
|
Serum creatinine is a standard clinical measurement for kidney function
|
0, 6, 12, 18, 24 weeks
|
Fasting glucose and Insulin
Time Frame: 0, 6, 12, 18, 24 weeks
|
Standard clinical measures
|
0, 6, 12, 18, 24 weeks
|
Fructosamine/Glycated Albumin
Time Frame: 0, 6, 12, 18, 24 weeks
|
Fructosamine and glycated albumin levels represent usual glycemia over the past 2-3 weeks, and are considered valid markers of short term clinical glycemic patterns by the American Diabetes Association
|
0, 6, 12, 18, 24 weeks
|
Blood pressure
Time Frame: 0, 6, 12, 18, 24 weeks
|
Systolic and Diastolic blood pressure, standard clinical measurement
|
0, 6, 12, 18, 24 weeks
|
Weight (kg)
Time Frame: 0, 6, 12, 18, 24 weeks
|
Weight measured on standardized scale in gown
|
0, 6, 12, 18, 24 weeks
|
Dietary Quality (Healthy Eating Index)
Time Frame: Run-in period (2 weeks), Active intervention (Up to 24 weeks).
|
Assessed by multiple unannounced 24-hour dietary recalls that will occur during the run-in to assess usual habits (2 recalls over 2 weeks) and the active intervention (5 recalls over 24 weeks), to measure any changes in diet quality metric.
Results will be used to calculate a metric of diet quality in the Healthy Eating Index that is based upon the USDA Dietary Guidelines.
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Run-in period (2 weeks), Active intervention (Up to 24 weeks).
|
DHP-18
Time Frame: 0, 6, 12, 18, 24 weeks
|
A diabetes-specific patient reported outcome measure developed to evaluate the health-related quality of life of people living with type 2 diabetes
|
0, 6, 12, 18, 24 weeks
|
Food Craving Inventory
Time Frame: 0, 6, 12, 18, 24 weeks
|
Measures different domains of general and specific food cravings
|
0, 6, 12, 18, 24 weeks
|
Sleep Quality and Patterns
Time Frame: 0, 6, 12, 18, 24 weeks
|
Pittsburgh Sleep Quality Index
|
0, 6, 12, 18, 24 weeks
|
Physical activity
Time Frame: All 14 day periods: Run-in (2-weeks, usual-baseline), weeks 11 and 12 (14 days), weeks 23 and 24 (14 days)
|
Objectively measured via Activpal
|
All 14 day periods: Run-in (2-weeks, usual-baseline), weeks 11 and 12 (14 days), weeks 23 and 24 (14 days)
|
Serotonin
Time Frame: 0, 12, 24 weeks: Samples collected and stabilized at these time points and frozen for future analyses
|
Chemical and neurotransmitter measured in blood with myriad roles, including appetite and digestion
|
0, 12, 24 weeks: Samples collected and stabilized at these time points and frozen for future analyses
|
Leptin
Time Frame: 0, 12, 24 weeks: Samples collected and stabilized at these time points and frozen for future analyses
|
Hormone measured in the blood with satiety related role
|
0, 12, 24 weeks: Samples collected and stabilized at these time points and frozen for future analyses
|
Thyroid Stimulating Hormone (TSH)
Time Frame: 0, 12, 24 weeks: Samples collected and stabilized at these time points and frozen for future analyses
|
Hormone measured in the blood with energy balance related role
|
0, 12, 24 weeks: Samples collected and stabilized at these time points and frozen for future analyses
|
Neuropeptide Y
Time Frame: 0, 12, 24 weeks: Samples collected and stabilized at these time points and frozen for future analyses
|
Peptide measured in the blood with satiety related role
|
0, 12, 24 weeks: Samples collected and stabilized at these time points and frozen for future analyses
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cholecystokinin (CCK)
Time Frame: 0, 12, 24 weeks: Samples collected and stabilized at these time points and frozen for future analyses
|
Peptide measured in the blood with satiety related role
|
0, 12, 24 weeks: Samples collected and stabilized at these time points and frozen for future analyses
|
Gut Microbiome
Time Frame: 0, 12, 24 weeks: Samples collected and stabilized at these time points and frozen for future analyses
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Measured with kit: Self-collection and stabilization of microbial DNA from feces for gut microbiome profiling
|
0, 12, 24 weeks: Samples collected and stabilized at these time points and frozen for future analyses
|
Comprehensive metabolomics
Time Frame: 0, 12, 24 weeks: Samples collected and stabilized at these time points and frozen for future analyses
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Serum collection for comprehensive metabolomics analysis for integrative analysis with gut microbiome
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0, 12, 24 weeks: Samples collected and stabilized at these time points and frozen for future analyses
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Dietary Practices
Time Frame: 0, 6, 12, 18, 24 weeks
|
Short questionnaire assessing dietary behaviors related to meal frequency, timing, and eating away from home
|
0, 6, 12, 18, 24 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
June 6, 2019
Primary Completion (Actual)
March 21, 2023
Study Completion (Actual)
March 21, 2023
Study Registration Dates
First Submitted
November 19, 2018
First Submitted That Met QC Criteria
May 8, 2019
First Posted (Actual)
May 9, 2019
Study Record Updates
Last Update Posted (Actual)
May 3, 2023
Last Update Submitted That Met QC Criteria
April 28, 2023
Last Verified
April 1, 2023
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- R01DK117028 [HS# 2018-4756]
- 1R01DK117028-01A1 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
IPD Plan Description
It is not yet known if there will be a plan to make IPD available.
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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