ObesitySAMSNCT02094768
Soda and Milk Study
A study testing Reduced Fat Milk and Sugar Sweetened Soda in people with Obesity and Dyslipidemia, run by UCSF Benioff Children's Hospital Oakland at 1 site in United States.
Trial summary
Much attention has been directed at the unhealthy effects of sugar-sweetened beverages (SSBs), as an increase in their consumption has paralleled the rise obesity rates. In adults, SSBs have been shown to promote ectopic fat storage and raise plasma triglycerides compared to equivalent amounts of semi-skim (1.5%)… Read more about this study
- Who is it for?
- Ages 13 to 18 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Obesity, Dyslipidemia
- What is being tested?
- Reduced Fat Milk and Sugar Sweetened Soda
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2014to May 2017
- 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 13 to 18 years
- Men only
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Males, age 13-18
- Tanner stage ≥ 2
- Self reported sugar sweetened beverage intake 24oz to 60oz per day
- Self reported milk intake ≤16 oz. per day
- BMI 85-99 percentile for age
- Tolerant to milk
Who cannot join
- History or diagnosis of hypertension or taking blood pressure lowering medication
- History or diagnosis of diabetes, HbA1c ≥ 6.5% or fasting glucose ≥ 126 mg/dl
- Fasting triglyceride > 300 mg/dl
- On lipid lowering or diabetes medication
Trial locations and contacts
1 site in 1 country.
United States1 site
Cholesterol Research Center
Berkeley, California, 94705
About this study
Official title: Effects of Replacing Sugar Sweetened Beverages With Milk on Metabolic Factors in Overweight and Obese Adolescents
Much attention has been directed at the unhealthy effects of sugar-sweetened beverages (SSBs), as an increase in their consumption has paralleled the rise obesity rates. In adults, SSBs have been shown to promote ectopic fat storage and raise plasma triglycerides compared to equivalent amounts of semi-skim (1.5%) milk, water, or diet beverages. Replacement of soda with milk had the added benefit of also reducing systolic blood pressure. While several studies have investigated the effects of SSBs on weight gain in children, no published studies have investigated their effects on lipid and lipoprotein risk factors under isocaloric conditions in metabolically at-risk adolescents, who are among the greatest consumers of SSBs. The main objective of this study is to test whether isocaloric replacement of soda with reduced fat milk will significantly improve atherogenic dyslipidemia, blood pressure, insulin sensitivity, and liver function in overweight and obese adolescents who are habitual soda consumers. The investigators will test this in a 8 week randomized two period crossover trial in 30 overweight and obese adolescent males who are self-reported habitual consumers of SSBs. Participants will consume energy equivalent amounts of SSB (24oz soda containing high fructose corn syrup per day), and reduced fat milk (2% milk fat) for 3 weeks each, in random order, separated by a 2-week washout. Anthropometrics, blood pressure, and blood samples will be collected at screen and at the end of each intervention period. Plasma measurements will include LDL peak particle diameter; lipoprotein subclass concentrations; triglycerides; total, LDL, and HDL-cholesterol; apolipoproteins; glucose, insulin, and insulin resistance; high sensitivity C-reactive protein; uric acid; and liver enzymes.
- Conditions
- Obesity, Dyslipidemia
- Being tested
- Reduced Fat Milk, Sugar Sweetened Soda
- Medical subject headings
- Obesity, Dyslipidemias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Reduced Fat MilkDietary supplement
Also called 2% milk
Subjects will be provided with and instructed to consume the equivalent of 20oz. reduced fat milk per day for 3 weeks
Sugar Sweetened SodaDietary supplement
Also called High fructose corn syrup sweetened soda
Subjects will be provided with and instructed to consume 2 cans (24oz) of sugar sweetened soda per day for 3 weeks
| Study group | Role | What they receive |
|---|---|---|
| Reduced Fat Milk | Experimental | 20 oz. reduced fat (2%) milk per day Receives: Dietary Supplement: Reduced Fat Milk |
| Sugar Sweetened Soda | Experimental | 24oz. soda per day Receives: Dietary Supplement: Sugar Sweetened Soda |
What is being measured
The primary outcome is the main question the study is designed to answer.
LDL peak particle diameter
Measured: 3 weeks
Secondary outcomes (8)
Plasma triglycerides
Measured: 3 weeks
LDL-cholesterol
Measured: 3 weeks
HDL-cholesterol
Measured: 3 weeks
Blood pressure
Systolic and diastolic
Measured: 3 weeks
LDL subclass concentrations
Measured: 3 weeks
Apolipoprotein B
Measured: 3 weeks
Apolipoprotein AI
Measured: 3 weeks
Apolipoprotein CIII
Measured: 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2014 (estimated)
- Study startApr 2014
- Primary completionSep 2016
- Study completionMay 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- UCSF Benioff Children's Hospital Oakland
- Sponsor type
- University, hospital or other
- Collaborators
- Almond Board of California
- Responsible party
- Sponsor
- Investigators
- Ronald M Krauss, MD, Principal investigator, UCSF Benioff Children's Hospital Oakland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02094768
- Sponsor's protocol ID
- MM7267
- Acronym
- SAMS
- Status last verified
- Oct 2017
- First submitted
- 20 Mar 2014
- Last updated
- 6 Nov 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Replacing Sugar Sweetened Beverages With Milk on Metabolic Factors in Overweight and Obese Adolescents
- ClinicalTrials.gov ID
- NCT02094768
- Acronym / sponsor ID
- SAMS / MM7267
- Conditions
- Obesity, Dyslipidemia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- UCSF Benioff Children's Hospital OaklandUniversity, hospital or other
- Collaborators
- Almond Board of California
- Study start
- Apr 2014 (actual)
- Primary completion
- Sep 2016 (actual)
- Study completion
- May 2017 (actual)
- First posted
- 24 Mar 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.
Much attention has been directed at the unhealthy effects of sugar-sweetened beverages (SSBs), as an increase in their consumption has paralleled the rise obesity rates. In adults, SSBs have been shown to promote ectopic fat storage and raise plasma triglycerides compared to equivalent amounts of semi-skim (1.5%) milk, water, or diet beverages. Replacement of soda with milk had the added benefit of also reducing systolic blood pressure. While several studies have investigated the effects of SSBs on weight gain in children, no published studies have investigated their effects on lipid and lipoprotein risk factors under isocaloric conditions in metabolically at-risk adolescents, who are among the greatest consumers of SSBs. The main objective of this study is to test whether isocaloric replacement of soda with reduced fat milk will significantly improve atherogenic dyslipidemia, blood pressure, insulin sensitivity, and liver function in overweight and obese adolescents who are habitual soda consumers. The investigators will test this in a 8 week randomized two period crossover trial in 30 overweight and obese adolescent males who are self-reported habitual consumers of SSBs. Participants will consume energy equivalent amounts of SSB (24oz soda containing high fructose corn syrup per day), and reduced fat milk (2% milk fat) for 3 weeks each, in random order, separated by a 2-week washout. Anthropometrics, blood pressure, and blood samples will be collected at screen and at the end of each intervention period. Plasma measurements will include LDL peak particle diameter; lipoprotein subclass concentrations; triglycerides; total, LDL, and HDL-cholesterol; apolipoproteins; glucose, insulin, and insulin resistance; high sensitivity C-reactive protein; uric acid; and liver enzymes.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Reduced Fat Milk | Experimental | Dietary Supplement: Reduced Fat Milk20 oz. reduced fat (2%) milk per day |
| Sugar Sweetened Soda | Experimental | Dietary Supplement: Sugar Sweetened Soda24oz. soda per day |
Who may qualify
- Ages
- 13 to 18 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (6 listed)
- Males, age 13-18
- Tanner stage ≥ 2
- Self reported sugar sweetened beverage intake 24oz to 60oz per day
- Self reported milk intake ≤16 oz. per day
- BMI 85-99 percentile for age
Key exclusion criteria (4 listed)
- History or diagnosis of hypertension or taking blood pressure lowering medication
- History or diagnosis of diabetes, HbA1c ≥ 6.5% or fasting glucose ≥ 126 mg/dl
- Fasting triglyceride > 300 mg/dl
- On lipid lowering or diabetes medication
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 |
|---|---|---|
| Reduced Fat MilkAlso: 2% milkSubjects will be provided with and instructed to consume the equivalent of 20oz. reduced fat milk per day for 3 weeks | Dietary supplement | Reduced Fat Milk |
| Sugar Sweetened SodaAlso: High fructose corn syrup sweetened sodaSubjects will be provided with and instructed to consume 2 cans (24oz) of sugar sweetened soda per day for 3 weeks | Dietary supplement | Sugar Sweetened Soda |
Primary outcome
LDL peak particle diameter
Time frame: 3 weeks
8 secondary outcomes
Plasma triglycerides
Time frame: 3 weeks
LDL-cholesterol
Time frame: 3 weeks
HDL-cholesterol
Time frame: 3 weeks
Blood pressure
Time frame: 3 weeks
LDL subclass concentrations
Time frame: 3 weeks
Apolipoprotein B
Time frame: 3 weeks
Apolipoprotein AI
Time frame: 3 weeks
Apolipoprotein CIII
Time frame: 3 weeks
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 6 Nov 2017.
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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.
Ronald M Krauss, MD principal investigator
UCSF Benioff Children's Hospital Oakland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Reduced Fat Milk and Sugar Sweetened Soda in people with Obesity and Dyslipidemia, run by UCSF Benioff Children's Hospital Oakland 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 6 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 6 Nov 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?
LDL peak particle diameter (time frame: 3 weeks). 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 6 Nov 2017.