Insulin SensitivityadolNCT02058914
Effects of Sugar Sweetened Beverage on Metabolic Health in Male and Female Adolescents
A study testing high fructose sweetened beverage and High Glucose sweetened beverage in people with Insulin Sensitivity and Insulin Tolerance, run by University of Missouri-Columbia at 1 site in United States.
Trial summary
We examined the effects of short-term (2-wk) consumption of HF- and HG-sweetened beverages in adolescents (15-20 yr of age) on insulin sensitivity, insulin secretion, insulin clearance, triacylglycerol (TAG), and cholesterol concentrations. Read more about this study
- Who is it for?
- Ages 15 to 20 yearsHealthy volunteers can take part
- Conditions the study is for
- Insulin Sensitivity, Insulin Tolerance
- What is being tested?
- high fructose sweetened beverage and High Glucose sweetened beverage
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2011to Apr 2013
- 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 15 to 20 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- males and females 15-20 years of age not participating in an organized sport (non-athletes) no history of heart, lung, kidney, endocrine, or gastrointestinal disease no medications known to alter glucose or lipid metabolism normal fasting blood glucose concentrations (< 100 mg/dL) normal fasting triglyceride concentrations (< 150 mg/dL) average daily fructose consumption < 90th percentile for age and sex
Who cannot join
- athlete type 1 diabetic type 2 diabetic consuming high quantities of fructose
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Moderate Amounts of High Fructose- or High Glucose-sweetened Beverages do Not Differentially Alter Metabolic Health in Male and Female Adolescents
We examined the effects of short-term (2-wk) consumption of HF- and HG-sweetened beverages in adolescents (15-20 yr of age) on insulin sensitivity, insulin secretion, insulin clearance, triacylglycerol (TAG), and cholesterol concentrations.
Read the detailed description
This counterbalanced study consisted of two trials including 1) high fructose (HF) trial and, 2) a high glucose (HG) trial. Each trial was blind to the participant, performed in a random order, and was 15 d in length. During days 1-14 of each trial, the participants consumed either 710 ml per day of a HF-sweetened beverage (sweetened with 50 g fructose and 15 g glucose) for 2-wk (HF trial) or 710 ml per day of a HG-sweetened beverage (sweetened with 50 g glucose and 15 g fructose) for 2-wk (HG trial) on top of their normal diet. In addition, the participants were instructed to maintain their normal physical activity levels during each trial (which were measured with an accelerometer). On day 15 of each trial, the participants reported to the lab after a ~ 11 h overnight fast for metabolic testing. During this testing day, the participants remained in the lab for 12 h and consumed three liquid meals (one meal every 4 h and HF meals during HF trial and HG meals during HG trial), while blood samples were taken every 15 or 30 min throughout the 12 h testing day. During testing, the participants remained physically inactive (< 3,000 steps).
- Conditions
- Insulin Sensitivity, Insulin Tolerance
- Being tested
- high fructose sweetened beverage, High Glucose sweetened beverage
- Keywords
- Sugar sweetened beverages, metabolism, endocrine, lipids, blood glucose
- Medical subject headings
- Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
high fructose sweetened beverageDietary supplement
710 ml per day of a HF-sweetened beverage
High Glucose sweetened beverageDietary supplement
HG-sweetened beverage
| Study group | Role | What they receive |
|---|---|---|
| high fructose sweetened beverage | Experimental | 710 ml per day of a HF-sweetened beverage (sweetened with 50 g fructose and 15 g glucose) Receives: Dietary Supplement: high fructose sweetened beverage |
| High Glucose sweetened beverage | Active comparator | HG-sweetened beverage (sweetened with 50 g glucose and 15 g fructose) Receives: Dietary Supplement: High Glucose sweetened beverage |
What is being measured
The primary outcome is the main question the study is designed to answer.
glucose concentrations
Measured: baseline and 15, 30, 45, 60, 75, 90, 120, 150, 180, 210, 240, 255, 270, 285, 300, 315, 330, 360, 390, 420, 450, 480, 495, 510, 525, 540, 555, 570, 600, 630, 660, 690, and 720
Secondary outcomes (1)
Triglycerides
Measured: baseline and 15, 30, 45, 60, 75, 90, 120, 150, 180, 210, 240, 255, 270, 285, 300, 315, 330, 360, 390, 420, 450, 480, 495, 510, 525, 540, 555, 570, 600, 630, 660, 690, and 720
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2014 (estimated)
- Study startSep 2011
- Primary completionApr 2013
- Study completionApr 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Insulin SensitivityStudies of the same condition, open and under way.
- More trials run by University of Missouri-ColumbiaThe sponsor's other registered studies.
- 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
- Other
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Missouri-Columbia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jill Kanaley, University of Missouri-Columbia
- Investigators
- Jill Kanaley, PhD, Principal investigator, University of Missouri-Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02058914
- Sponsor's protocol ID
- fructadol
- Acronym
- adol
- Status last verified
- Jun 2017
- First submitted
- 6 Feb 2014
- Last updated
- 8 Jun 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Heden TD, Liu Y, Park YM, Nyhoff LM, Winn NC, Kanaley JA. Moderate amounts of fructose- or glucose-sweetened beverages do not differentially alter metabolic health in male and female adolescents. Am J Clin Nutr. 2014 Sep;100(3):796-805. doi: 10.3945/ajcn.113.081232. Epub 2014 Jul 16.
PubMed 25030782
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Moderate Amounts of High Fructose- or High Glucose-sweetened Beverages do Not Differentially Alter Metabolic Health in Male and Female Adolescents
- ClinicalTrials.gov ID
- NCT02058914
- Acronym / sponsor ID
- adol / fructadol
- Conditions
- Insulin Sensitivity, Insulin Tolerance
- Keywords
- Sugar sweetened beverages, metabolism, endocrine, lipids, blood glucose
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University of Missouri-ColumbiaUniversity, hospital or other
- Study start
- Sep 2011
- Primary completion
- Apr 2013 (actual)
- Study completion
- Apr 2013 (actual)
- First posted
- 10 Feb 2014 (estimated)
- 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.
We examined the effects of short-term (2-wk) consumption of HF- and HG-sweetened beverages in adolescents (15-20 yr of age) on insulin sensitivity, insulin secretion, insulin clearance, triacylglycerol (TAG), and cholesterol concentrations.
Detailed description
This counterbalanced study consisted of two trials including 1) high fructose (HF) trial and, 2) a high glucose (HG) trial. Each trial was blind to the participant, performed in a random order, and was 15 d in length. During days 1-14 of each trial, the participants consumed either 710 ml per day of a HF-sweetened beverage (sweetened with 50 g fructose and 15 g glucose) for 2-wk (HF trial) or 710 ml per day of a HG-sweetened beverage (sweetened with 50 g glucose and 15 g fructose) for 2-wk (HG trial) on top of their normal diet. In addition, the participants were instructed to maintain their normal physical activity levels during each trial (which were measured with an accelerometer). On day 15 of each trial, the participants reported to the lab after a ~ 11 h overnight fast for metabolic testing. During this testing day, the participants remained in the lab for 12 h and consumed three liquid meals (one meal every 4 h and HF meals during HF trial and HG meals during HG trial), while blood samples were taken every 15 or 30 min throughout the 12 h testing day. During testing, the participants remained physically inactive (< 3,000 steps).
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| high fructose sweetened beverage | Experimental | Dietary Supplement: high fructose sweetened beverage710 ml per day of a HF-sweetened beverage (sweetened with 50 g fructose and 15 g glucose) |
| High Glucose sweetened beverage | Active comparator | Dietary Supplement: High Glucose sweetened beverageHG-sweetened beverage (sweetened with 50 g glucose and 15 g fructose) |
Who may qualify
- Ages
- 15 to 20 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- males and females 15-20 years of age not participating in an organized sport (non-athletes) no history of heart, lung, kidney, endocrine, or gastrointestinal disease no medications known to alter glucose or lipid metabolism normal fasting blood glucose concentrations (< 100 mg/dL) normal fasting triglyceride concentrations (< 150 mg/dL) average daily fructose consumption < 90th percentile for age and sex
Key exclusion criteria (1 listed)
- athlete type 1 diabetic type 2 diabetic consuming high quantities of fructose
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 |
|---|---|---|
| high fructose sweetened beverage710 ml per day of a HF-sweetened beverage | Dietary supplement | high fructose sweetened beverage |
| High Glucose sweetened beverageHG-sweetened beverage | Dietary supplement | High Glucose sweetened beverage |
Primary outcome
glucose concentrations
Time frame: baseline and 15, 30, 45, 60, 75, 90, 120, 150, 180, 210, 240, 255, 270, 285, 300, 315, 330, 360, 390, 420, 450, 480, 495, 510, 525, 540, 555, 570, 600, 630, 660, 690, and 720
1 secondary outcome
Triglycerides
Time frame: baseline and 15, 30, 45, 60, 75, 90, 120, 150, 180, 210, 240, 255, 270, 285, 300, 315, 330, 360, 390, 420, 450, 480, 495, 510, 525, 540, 555, 570, 600, 630, 660, 690, and 720
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 Jun 2017.
- Derived from this study: PubMed 25030782Heden TD, Liu Y, Park YM, Nyhoff LM, Winn NC, Kanaley JA. Moderate amounts of fructose- or glucose-sweetened beverages do not differentially alter metabolic health in male and female adolescents. Am J Clin Nutr. 2014 Sep;100(3):796-805. doi: 10.3945/ajcn.113.081232. Epub 2014 Jul 16.
- Individual participant dataSharing planned: No
Related trials for Insulin Sensitivity
Active, not recruiting
Effect of Probiotics on Insulin Sensitivity in Overweight and Obese Pregnancy
Obesity & Overweight, Gestational Diabetes Mellitus (GDM)
Not yet recruitingPhase 2
Trial of the Combination of Alpha-Lipoic Acid and Mirabegron in Women and in Men With Obesity
Insulin Resistance, Obesity
Recruiting
Improving Sleep Health and Circadian Timing to Support Cardiometabolic Health in Adolescents
Overweight Adolescents, Sleep
Not yet recruitingObservational study
Clinical Research Trial to Study Insulin Sensitivity Using Automated Glucose Clamp Technology
Obesity Type 2 Diabetes Mellitus, Obese Adults
Not yet recruiting
Effects of Mango on Insulin Sensitivity in Prediabetes
Pre Diabetes
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.
Jill Kanaley, PhD principal investigator
University of Missouri-Columbia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing high fructose sweetened beverage and High Glucose sweetened beverage in people with Insulin Sensitivity and Insulin Tolerance, run by University of Missouri-Columbia 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 1 inclusion and 1 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 Jun 2017. 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?
glucose concentrations (time frame: baseline and 15, 30, 45, 60, 75, 90, 120, 150, 180, 210, 240, 255, 270, 285, 300, 315, 330, 360, 390, 420, 450, 480, 495, 510, 525, 540, 555, 570, 600, 630, 660, 690, and 720). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02058914, which also lists 1 linked publication.
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 Jun 2017.