Cardiovascular Disease, ObesityBASH IIINCT01295671
Beverages and Societal Health
A study testing Provision of beverages in people with Cardiovascular Disease, Obesity, run by Boston Children's Hospital at 1 site in United States.
Trial summary
The overall aim of the study is to compare the effects of three types of beverages - sugar-sweetened (SSB), artificially sweetened (ASB), and unsweetened (USB) - on cardiovascular disease (CVD) risk factors and body weight among young adults. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Cardiovascular Disease, Obesity
- What is being tested?
- Provision of beverages
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 203 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2011to Nov 2015
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Aged 18 to 40 years
- Consumption of at least 12 fluid ounces of sugar-sweetened beverage per day
- Willingness to consume types of beverages consistent with group assignment
- Body mass index (BMI) ranging from 18.5 - 40 kg/m2, and body weight ≤275 pounds
- Access to a working telephone or cell phone
Who cannot join
- Intention to move away from the greater Boston area during the projected period of study enrollment (i.e., 1 year post-randomization)
- Plans to be away from home for 5 weeks or longer during the study period (e.g., moving away from the greater Boston area during the summer)
- Physician diagnosis of a major medical illness, eating disorder, or phenylketonuria (PKU)
- Chronic use of any medication that may affect one or more study endpoints
- Impaired fasting glucose (IFG, fasting blood glucose ≥110 mg/dL)
- Current moderate or heavy smoker (>10 cigarettes per day)
Show all 10Show fewer
- Another member of the family (i.e., first degree relative) or household participating in the study If female,
- Pregnant in the past 12 months or planning to become pregnant during the study period
- Lactating in the preceding 3 months
- Change in birth control medication in previous 3 months or plans to change during the study period
Trial locations and contacts
1 site in 1 country.
United States1 site
Children's Hospital Boston
Boston, Massachusetts, 02115
About this study
Official title: Sugar Sweetened Beverages And Cardiovascular Disease Risk
The overall aim of the study is to compare the effects of three types of beverages - sugar-sweetened (SSB), artificially sweetened (ASB), and unsweetened (USB) - on cardiovascular disease (CVD) risk factors and body weight among young adults.
Read the detailed description
Consumption of sugar sweetened beverages (SSB) has been linked to obesity and, independent of body weight, risk for diabetes and cardiovascular disease. With rising public health awareness of these potential adverse effects, consumption of artificially sweetened beverages (ASB) has increased dramatically. These low-calorie products are marketed as "diet," with the implication that they promote weight loss and improved health. However, there are no long-term experimental studies of ASB and body weight or any other health outcome. Several recent prospective observational studies have linked intake of ASB to increased risk of the metabolic syndrome, type 2 diabetes, and obesity. In the proposed clinical trial, 270 young adults who habitually consume SSB will be randomly assigned to one of three groups: 1) to continue consuming habitual levels of SSB; 2) to substitute ASB for SSB; or 3) to substitute unsweetened beverages for SSB. Each group will receive home delivery of the targeted beverage for 1 year, using methods that build upon previous successful work. Careful attention will be given to assuring treatment fidelity, equivalence of treatment intensity, and avoidance of experimental confounders. The primary study endpoint will be the ratio of serum triglyceride to HDL-cholesterol concentrations. Secondary endpoints will include changes in other cardiovascular disease risk factors, body weight, dietary quality, and taste preferences.
- Conditions
- Cardiovascular Disease, Obesity
- Being tested
- Provision of beverages
- Medical subject headings
- Cardiovascular Diseases, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Provision of beveragesBehavioural
Home delivery of specified beverage type
| Study group | Role | What they receive |
|---|---|---|
| Sugar-Sweetened Beverages | Active comparator | Provision of beverages: Sugar-sweetened beverages Receives: Behavioral: Provision of beverages |
| Artificially-sweetened Beverages | Experimental | Provision of beverages: Artificially-sweetened beverages Receives: Behavioral: Provision of beverages |
| Unsweetened Beverages | Experimental | Provision of beverages: Unsweetened beverages Receives: Behavioral: Provision of beverages |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ratio of Serum Triglyceride to HDL-cholesterol Concentration (TG:HDLC)
Measured: 12 Month
Secondary outcomes (10)
LDL-C
LDL-C
Measured: 12 Month
hsCRP
hsCRP
Measured: 12 Month
Fibrinogen
Fibrinogen
Measured: 12 Month
Uric Acid
Uric Acid
Measured: 12 Month
ALT
ALT
Measured: 12 Month
Systolic Blood Pressure
Systolic Blood Pressure
Measured: 12 Month
Diastolic Blood Pressure
Diastolic Blood Pressure
Measured: 12 Month
Body Weight
Body Weight
Measured: 12 Month
Diet Quality: Sugar-Sweetened Beverage Consumption
Diet Quality: Sugar-Sweetened Beverage Consumption - servings per day
Measured: 12 Month
Preference for Sweet Taste
We evaluated preference for sweet taste using ten solutions ranging in sucrose concentration (%m/v) from 0% (sample 1) to 18% (sample 10). After tasting each solution, participant reported the sample number corresponding to his or her overall favorite.
Measured: 12 Month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Feb 2011 (estimated)
- Study startFeb 2011
- Primary completionNov 2015
- Study completionNov 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Cardiovascular Disease, ObesityStudies of the same condition, open and under way.
- More trials run by Boston Children's HospitalThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 203 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston Children's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Principal investigator, David S. Ludwig, MD, PhD, Boston Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01295671
- Sponsor's protocol ID
- 10-06-0242
- Acronym
- BASH III
- Status last verified
- Feb 2018
- First submitted
- 11 Feb 2011
- Last updated
- 27 Mar 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Ebbeling CB, Feldman HA, Osganian SK, Chomitz VR, Ellenbogen SJ, Ludwig DS. Effects of decreasing sugar-sweetened beverage consumption on body weight in adolescents: a randomized, controlled pilot study. Pediatrics. 2006 Mar;117(3):673-80. doi: 10.1542/peds.2005-0983.
PubMed 16510646Ebbeling CB, Feldman HA, Chomitz VR, Antonelli TA, Gortmaker SL, Osganian SK, Ludwig DS. A randomized trial of sugar-sweetened beverages and adolescent body weight. N Engl J Med. 2012 Oct 11;367(15):1407-16. doi: 10.1056/NEJMoa1203388. Epub 2012 Sep 21.
PubMed 22998339Ebbeling CB, Feldman HA, Steltz SK, Quinn NL, Robinson LM, Ludwig DS. Effects of Sugar-Sweetened, Artificially Sweetened, and Unsweetened Beverages on Cardiometabolic Risk Factors, Body Composition, and Sweet Taste Preference: A Randomized Controlled Trial. J Am Heart Assoc. 2020 Aug 4;9(15):e015668. doi: 10.1161/JAHA.119.015668. Epub 2020 Jul 22.
PubMed 32696704
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sugar Sweetened Beverages And Cardiovascular Disease Risk
- ClinicalTrials.gov ID
- NCT01295671
- Acronym / sponsor ID
- BASH III / 10-06-0242
- Conditions
- Cardiovascular Disease, Obesity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 203 participants (actual)
- Lead sponsor
- Boston Children's HospitalUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- Feb 2011
- Primary completion
- Nov 2015 (actual)
- Study completion
- Nov 2015 (actual)
- First posted
- 14 Feb 2011 (estimated)
- Results
- Posted 27 Mar 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The overall aim of the study is to compare the effects of three types of beverages - sugar-sweetened (SSB), artificially sweetened (ASB), and unsweetened (USB) - on cardiovascular disease (CVD) risk factors and body weight among young adults.
Detailed description
Consumption of sugar sweetened beverages (SSB) has been linked to obesity and, independent of body weight, risk for diabetes and cardiovascular disease. With rising public health awareness of these potential adverse effects, consumption of artificially sweetened beverages (ASB) has increased dramatically. These low-calorie products are marketed as "diet," with the implication that they promote weight loss and improved health. However, there are no long-term experimental studies of ASB and body weight or any other health outcome. Several recent prospective observational studies have linked intake of ASB to increased risk of the metabolic syndrome, type 2 diabetes, and obesity. In the proposed clinical trial, 270 young adults who habitually consume SSB will be randomly assigned to one of three groups: 1) to continue consuming habitual levels of SSB; 2) to substitute ASB for SSB; or 3) to substitute unsweetened beverages for SSB. Each group will receive home delivery of the targeted beverage for 1 year, using methods that build upon previous successful work. Careful attention will be given to assuring treatment fidelity, equivalence of treatment intensity, and avoidance of experimental confounders. The primary study endpoint will be the ratio of serum triglyceride to HDL-cholesterol concentrations. Secondary endpoints will include changes in other cardiovascular disease risk factors, body weight, dietary quality, and taste preferences.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Sugar-Sweetened Beverages | Active comparator | Behavioral: Provision of beveragesProvision of beverages: Sugar-sweetened beverages |
| Artificially-sweetened Beverages | Experimental | Behavioral: Provision of beveragesProvision of beverages: Artificially-sweetened beverages |
| Unsweetened Beverages | Experimental | Behavioral: Provision of beveragesProvision of beverages: Unsweetened beverages |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Aged 18 to 40 years
- Consumption of at least 12 fluid ounces of sugar-sweetened beverage per day
- Willingness to consume types of beverages consistent with group assignment
- Body mass index (BMI) ranging from 18.5 - 40 kg/m2, and body weight ≤275 pounds
- Access to a working telephone or cell phone
Key exclusion criteria (10 listed)
- Intention to move away from the greater Boston area during the projected period of study enrollment (i.e., 1 year post-randomization)
- Plans to be away from home for 5 weeks or longer during the study period (e.g., moving away from the greater Boston area during the summer)
- Physician diagnosis of a major medical illness, eating disorder, or phenylketonuria (PKU)
- Chronic use of any medication that may affect one or more study endpoints
- Impaired fasting glucose (IFG, fasting blood glucose ≥110 mg/dL)
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 |
|---|---|---|
| Provision of beveragesHome delivery of specified beverage type | Behavioural | Artificially-sweetened Beverages, Sugar-Sweetened Beverages, Unsweetened Beverages |
Primary outcome
Ratio of Serum Triglyceride to HDL-cholesterol Concentration (TG:HDLC)
Time frame: 12 Month
10 secondary outcomes
LDL-C
Time frame: 12 Month
hsCRP
Time frame: 12 Month
Fibrinogen
Time frame: 12 Month
Uric Acid
Time frame: 12 Month
ALT
Time frame: 12 Month
Systolic Blood Pressure
Time frame: 12 Month
Diastolic Blood Pressure
Time frame: 12 Month
Body Weight
Time frame: 12 Month
Diet Quality: Sugar-Sweetened Beverage Consumption
Time frame: 12 Month
Preference for Sweet Taste
Time frame: 12 Month
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 16510646Ebbeling CB, Feldman HA, Osganian SK, Chomitz VR, Ellenbogen SJ, Ludwig DS. Effects of decreasing sugar-sweetened beverage consumption on body weight in adolescents: a randomized, controlled pilot study. Pediatrics. 2006 Mar;117(3):673-80. doi: 10.1542/peds.2005-0983.
- Background: PubMed 22998339Ebbeling CB, Feldman HA, Chomitz VR, Antonelli TA, Gortmaker SL, Osganian SK, Ludwig DS. A randomized trial of sugar-sweetened beverages and adolescent body weight. N Engl J Med. 2012 Oct 11;367(15):1407-16. doi: 10.1056/NEJMoa1203388. Epub 2012 Sep 21.
- Derived from this study: PubMed 32696704Ebbeling CB, Feldman HA, Steltz SK, Quinn NL, Robinson LM, Ludwig DS. Effects of Sugar-Sweetened, Artificially Sweetened, and Unsweetened Beverages on Cardiometabolic Risk Factors, Body Composition, and Sweet Taste Preference: A Randomized Controlled Trial. J Am Heart Assoc. 2020 Aug 4;9(15):e015668. doi: 10.1161/JAHA.119.015668. Epub 2020 Jul 22.
- Individual participant dataSharing planned: No
Related trials for Cardiovascular Disease, Obesity
RecruitingPhase 1/2
HS235 Study in Overweight and Obese Participants With Combined Pre and Post-Capillary Pulmonary Hypertension Due to Heart Failure With Preserved Ejection Fraction
Pulmonary Hypertension, Heart Failure With Preserved Ejection Fraction
Active, not recruitingPhase 3
Evaluating the Impact of Maridebart Cafraglutide on Cardiovascular Outcomes in Participants With Atherosclerotic Cardiovascular Disease and Overweight or Obesity
Atherosclerotic Cardiovascular Disease, Overweight
RecruitingPhase 3
Maridebart Cafraglutide in Heart Failure With Preserved or Mildly Reduced Ejection Fraction and Obesity
Heart Failure With Preserved Ejection Fraction, Heart Failure With Mildly Reduced Ejection Fraction
Recruiting
Smartwatch-based Intervention for Cardiovascular Health (SWITCH)
Overweight , Obesity, Prediabetes
Recruiting
Tailoring Mobile Health Technology to Reduce Obesity and Improve Cardiovascular Health in Resource-Limited Neighborhood Environments
Obesity
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Provision of beverages in people with Cardiovascular Disease, Obesity, run by Boston Children's Hospital 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 5 inclusion and 10 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 27 Mar 2018. 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?
Yes. Results are posted in the registry (first posted 27 Mar 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Ratio of Serum Triglyceride to HDL-cholesterol Concentration (TG:HDLC) (time frame: 12 Month). 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 NCT01295671, which also lists 3 linked publications.
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 27 Mar 2018.