Metabolic SyndromeNCT04118257
Short-term Sugary Beverage Consumption on Glucose Control and Cardiovascular Disease Risk Factors
A study testing Sugary beverage: Fruit juice and Sugary beverage: Soda in people with Metabolic Syndrome, run by Kansas State University at 1 site in United States.
Trial summary
Our goal is to determine how the addition of sugar-sweetened beverages to the diet affects glucose control, cardiovascular disease risk factors, and pulmonary function in healthy, young adults. Read more about this study
- Who is it for?
- Ages 18 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Metabolic Syndrome
- What is being tested?
- Sugary beverage: Fruit juice and Sugary beverage: Soda
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 37 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Feb 2017to 14 Nov 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 30 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Free from diagnosis of diabetes and pulmonary illness
- Have no intake of glucose or lipid lowering medication.
Who cannot join
- Smoke
- Currently pregnant
- Have bronchitis
- Have more than 2 risk factors for cardiovascular disease, as defined by the American College of Sports Medicine (ACSM).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Short-term Sugary Beverage Consumption on Type-2 Diabetes and Cardiovascular Disease Risk Factors: A Randomized Controlled Trial
Our goal is to determine how the addition of sugar-sweetened beverages to the diet affects glucose control, cardiovascular disease risk factors, and pulmonary function in healthy, young adults.
Read the detailed description
In a 3-arm randomized controlled trial, 36 participants consumed one of three beverages for three weeks: water (W), caffeine-free soda (S), or 100% fruit juice (FJ). Participants consumed two servings/day (~710mL) of their randomized beverage for three weeks, along with their habitual diets. At baseline and following the 3-week intervention, participants completed glucose control, cardiovascular disease risk factor, and pulmonary function assessments.
- Conditions
- Metabolic Syndrome
- Being tested
- Sugary beverage: Fruit juice, Sugary beverage: Soda, Control: Water
- Keywords
- Glucose control, Cardiovascular disease risk factors, Sugary beverages, Pulmonary function
- Medical subject headings
- Metabolic Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sugary beverage: Fruit juiceDietary supplement
Participants consumed 100% fruit juice (~710mL) daily for three weeks, along with their habitual diets.
Sugary beverage: SodaDietary supplement
Participants consumed soda (~710mL) daily for three weeks, along with their habitual diets.
Control: WaterDietary supplement
Participants consumed water (~710mL) daily for three weeks, along with their habitual diets.
| Study group | Role | What they receive |
|---|---|---|
| Fruit Juice | Experimental | Participants consumed 2 bottles of 100% fruit juice daily for 3 weeks. Receives: Dietary Supplement: Sugary beverage: Fruit juice |
| Soda | Experimental | Participants consumed 2 cans of caffeine-free Coca Cola daily for 3 weeks. Receives: Dietary Supplement: Sugary beverage: Soda |
| Water | Other | Participants consumed 2 bottles of water daily for 3 weeks. Receives: Dietary Supplement: Control: Water |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in glucose iAUC
Glucose obtained from blood sample in a fasted state and in response to a meal
Measured: Week 0 and Week 3
Secondary outcomes (7)
Change in plasma lipids
Total cholesterol (TC), LDL-c , VLDL-c, HDL-c , triglycerides (TG) from blood sample in a fasted state and following consumption of a meal
Measured: Week 0 and Week 3
Change in homeostatic model assessment for insulin resistance
Calculated from fasting glucose and insulin values
Measured: Week 0 and Week 3
Change in blood pressure
Evaluated via automated sphygmomanometer.
Measured: Week 0 and Week 3
Change in BMI
Weight and height will be combined to report BMI in kg/m^2
Measured: Week 0 and Week 3
Change in pulmonary function
Assessed using the maximum flow-volume loop
Measured: Week 0 and Week 3
Change in insulin iAUC
Glucose obtained from blood sample in a fasted state and in response to a meal
Measured: Week 0 and Week 3
Change in serum fructosamine
Fructosamine obtained from blood sample
Measured: Week 0 and Week 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2019
- Study start10 Feb 2017
- Primary completion14 Nov 2018
- Study completion14 Nov 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metabolic SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 37 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kansas State University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sara K Rosenkranz, Kansas State University
- Investigators
- Sara Rosenkranz, PhD, Principal investigator, Kansas State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04118257
- Sponsor's protocol ID
- Pro8531
- Status last verified
- Oct 2019
- First submitted
- 1 Oct 2019
- Last updated
- 8 Oct 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Short-term Sugary Beverage Consumption on Type-2 Diabetes and Cardiovascular Disease Risk Factors: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04118257
- Acronym / sponsor ID
- Pro8531
- Conditions
- Metabolic Syndrome
- Keywords
- Glucose control, Cardiovascular disease risk factors, Sugary beverages, Pulmonary function
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 37 participants (actual)
- Lead sponsor
- Kansas State UniversityUniversity, hospital or other
- Study start
- 10 Feb 2017 (actual)
- Primary completion
- 14 Nov 2018 (actual)
- Study completion
- 14 Nov 2018 (actual)
- First posted
- 8 Oct 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Our goal is to determine how the addition of sugar-sweetened beverages to the diet affects glucose control, cardiovascular disease risk factors, and pulmonary function in healthy, young adults.
Detailed description
In a 3-arm randomized controlled trial, 36 participants consumed one of three beverages for three weeks: water (W), caffeine-free soda (S), or 100% fruit juice (FJ). Participants consumed two servings/day (~710mL) of their randomized beverage for three weeks, along with their habitual diets. At baseline and following the 3-week intervention, participants completed glucose control, cardiovascular disease risk factor, and pulmonary function assessments.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Fruit Juice | Experimental | Dietary Supplement: Sugary beverage: Fruit juiceParticipants consumed 2 bottles of 100% fruit juice daily for 3 weeks. |
| Soda | Experimental | Dietary Supplement: Sugary beverage: SodaParticipants consumed 2 cans of caffeine-free Coca Cola daily for 3 weeks. |
| Water | Other | Dietary Supplement: Control: WaterParticipants consumed 2 bottles of water daily for 3 weeks. |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Free from diagnosis of diabetes and pulmonary illness
- Have no intake of glucose or lipid lowering medication.
Key exclusion criteria (4 listed)
- Smoke
- Currently pregnant
- Have bronchitis
- Have more than 2 risk factors for cardiovascular disease, as defined by the American College of Sports Medicine (ACSM).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sugary beverage: Fruit juiceParticipants consumed 100% fruit juice (~710mL) daily for three weeks, along with their habitual diets. | Dietary supplement | Fruit Juice |
| Sugary beverage: SodaParticipants consumed soda (~710mL) daily for three weeks, along with their habitual diets. | Dietary supplement | Soda |
| Control: WaterParticipants consumed water (~710mL) daily for three weeks, along with their habitual diets. | Dietary supplement | Water |
Primary outcome
Change in glucose iAUC
Time frame: Week 0 and Week 3
Glucose obtained from blood sample in a fasted state and in response to a meal
7 secondary outcomes
Change in plasma lipids
Time frame: Week 0 and Week 3
Change in homeostatic model assessment for insulin resistance
Time frame: Week 0 and Week 3
Change in blood pressure
Time frame: Week 0 and Week 3
Change in BMI
Time frame: Week 0 and Week 3
Change in pulmonary function
Time frame: Week 0 and Week 3
Change in insulin iAUC
Time frame: Week 0 and Week 3
Change in serum fructosamine
Time frame: Week 0 and Week 3
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2019.
- Individual participant dataSharing planned: No
Related trials for Metabolic Syndrome
RecruitingObservational study
Defining the Natural History of Squamous Cell Carcinoma in Fanconi Anemia
Fanconi Anemia, Inherited Bone Marrow Failure Syndrome
Not yet recruitingPhase 2
Osilodrostat for Glycemic Control in Mild Autonomous Cortisol Secretion (MACS) With Difficult-To-Control Type 2 Diabetes - A Randomized, Double-Blind, Placebo-Controlled Phase 2 Study
Mild Autonomous Cortisol Secretion (MACS), Diabetes Mellitus (Type 2)
Active, not recruiting
Effects of Whole-body Electrical Muscle Stimulation Exercise on Adults With Neuromuscular Disease
Neuromuscular Diseases (NMD), Amyotrophic Lateral Sclerosis
Not yet recruitingObservational study
Clinical Genetics Branch Eligibility Screening Survey
Melanoma, Li-Fraumeni Syndrome
Not yet recruitingPhase 2
Effects of Meal Macronutrients on Postprandial Lipids
Nephrotic Syndrome, Lipodystrophy
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sara Rosenkranz, PhD principal investigator
Kansas State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sugary beverage: Fruit juice and Sugary beverage: Soda in people with Metabolic Syndrome, run by Kansas State University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in glucose iAUC (time frame: Week 0 and Week 3). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Oct 2019; AzTrials last refreshed its copy on 7 Nov 2026.