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CompletedNCT01295671BASH IIIUpdated Mar 27, 2018Results posted

Beverages and Societal Health

An interventional study of Provision of beverages in Cardiovascular Disease, Obesity, sponsored by Boston Children's Hospital. Completed at 1 site in United States. Open to participants aged 18 Years to 40 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-03-27.

Sponsored by Boston Children's Hospital · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
203
Allocation
Randomized
Ages
18 Years to 40 Years
Sex
All
01

Study 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 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.

02

Conditions studied

  • Cardiovascular Disease, Obesity
03

In context

Cardiovascular Diseases

4,904 studies on the registry are indexed under Cardiovascular Diseases; 920 are open to participants now.

This study's enrollment of 203 is above the median of 100 across 2,738 interventional studies indexed under Cardiovascular Diseases.

Browse Cardiovascular Diseases studies →

Lead sponsor

Boston Children's Hospital is the lead sponsor of 598 studies on the registry; 151 are open to participants now.

Of its 31 completed or terminated interventional studies of FDA-regulated products, 18 (58%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 40 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria:

  • 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)
  • 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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
203 participants (actual)

Study arms

  • Active comparator
    Sugar-Sweetened Beverages

    Provision of beverages: Sugar-sweetened beverages

    Behavioral: Provision of beverages

  • Experimental
    Artificially-sweetened Beverages

    Provision of beverages: Artificially-sweetened beverages

    Behavioral: Provision of beverages

  • Experimental
    Unsweetened Beverages

    Provision of beverages: Unsweetened beverages

    Behavioral: Provision of beverages

Interventions

  • BehavioralProvision of beverages

    Home delivery of specified beverage type

06

What researchers measure

Primary outcomes

  1. Ratio of Serum Triglyceride to HDL-cholesterol Concentration (TG:HDLC)

    Time frame: 12 Month

Secondary outcomes

  1. LDL-C

    LDL-C

    Time frame: 12 Month

  2. hsCRP

    hsCRP

    Time frame: 12 Month

  3. Fibrinogen

    Fibrinogen

    Time frame: 12 Month

  4. Uric Acid

    Uric Acid

    Time frame: 12 Month

  5. ALT

    ALT

    Time frame: 12 Month

  6. Systolic Blood Pressure

    Systolic Blood Pressure

    Time frame: 12 Month

  7. Diastolic Blood Pressure

    Diastolic Blood Pressure

    Time frame: 12 Month

  8. Body Weight

    Body Weight

    Time frame: 12 Month

  9. Diet Quality: Sugar-Sweetened Beverage Consumption

    Diet Quality: Sugar-Sweetened Beverage Consumption - servings per day

    Time frame: 12 Month

  10. 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.

    Time frame: 12 Month

07

Results

Posted Mar 27, 2018

Participant flow

Subjects were recruited from the Boston metro area via multiple recruitment methods (i.e., print media, social media) from February 2011 through October 2014.

Participant flow — Overall Study
MilestoneSugar-Sweetened BeveragesArtificially-sweetened BeveragesUnsweetened Beverages
Started676769
Completed606066
Not completed773
Withdrew: Lost to follow-up463
Withdrew: Withdrawal by subject310

Outcome measures

PrimaryRatio of Serum Triglyceride to HDL-cholesterol Concentration (TG:HDLC)
Time frame:
12 Month
Reported as:
Median · ratio of Triglycerides-to-HDL
Ratio of Serum Triglyceride to HDL-cholesterol Concentration (TG:HDLC)
ratio of Triglycerides-to-HDLSugar-Sweetened BeveragesArtificially-sweetened BeveragesUnsweetened Beverages
Ratio of Serum Triglyceride to HDL-cholesterol Concentration (TG:HDLC)1.46 (0.98 to 2.19)1.19 (0.86 to 1.87)1.45 (0.99 to 2.31)
SecondaryLDL-C

LDL-C

Time frame:
12 Month
Reported as:
Mean · mg/dL
LDL-C
mg/dLSugar-Sweetened BeveragesArtificially-sweetened BeveragesUnsweetened Beverages
LDL-C103 ± 31104 ± 30109 ± 29
SecondaryhsCRP

hsCRP

Time frame:
12 Month
Reported as:
Median · mg/L
hsCRP
mg/LSugar-Sweetened BeveragesArtificially-sweetened BeveragesUnsweetened Beverages
hsCRP0.86 (0.39 to 1.80)0.64 (0.39 to 1.81)0.85 (0.39 to 1.76)
SecondaryFibrinogen

Fibrinogen

Time frame:
12 Month
Reported as:
Mean · mg/dL
Fibrinogen
mg/dLSugar-Sweetened BeveragesArtificially-sweetened BeveragesUnsweetened Beverages
Fibrinogen244 ± 49248 ± 62236 ± 73
SecondaryUric Acid

Uric Acid

Time frame:
12 Month
Reported as:
Mean · mg/dL
Uric Acid
mg/dLSugar-Sweetened BeveragesArtificially-sweetened BeveragesUnsweetened Beverages
Uric Acid5.2 ± 1.35.1 ± 1.45.4 ± 1.5
SecondaryALT

ALT

Time frame:
12 Month
Reported as:
Median · U/L
ALT
U/LSugar-Sweetened BeveragesArtificially-sweetened BeveragesUnsweetened Beverages
ALT16 (12 to 21)16 (13 to 23)17 (11 to 26)
SecondarySystolic Blood Pressure

Systolic Blood Pressure

Time frame:
12 Month
Reported as:
Mean · mmHg
Systolic Blood Pressure
mmHgSugar-Sweetened BeveragesArtificially-sweetened BeveragesUnsweetened Beverages
Systolic Blood Pressure109 ± 10107 ± 11106 ± 9
SecondaryDiastolic Blood Pressure

Diastolic Blood Pressure

Time frame:
12 Month
Reported as:
Mean · mmHg
Diastolic Blood Pressure
mmHgSugar-Sweetened BeveragesArtificially-sweetened BeveragesUnsweetened Beverages
Diastolic Blood Pressure68 ± 967 ± 867 ± 8
SecondaryBody Weight

Body Weight

Time frame:
12 Month
Reported as:
Mean · kg
Body Weight
kgSugar-Sweetened BeveragesArtificially-sweetened BeveragesUnsweetened Beverages
Body Weight78.0 ± 17.476.8 ± 17.278.3 ± 17.1
SecondaryDiet Quality: Sugar-Sweetened Beverage Consumption

Diet Quality: Sugar-Sweetened Beverage Consumption - servings per day

Time frame:
12 Month
Reported as:
Mean · Servings per day
Diet Quality: Sugar-Sweetened Beverage Consumption
Servings per daySugar-Sweetened BeveragesArtificially-sweetened BeveragesUnsweetened Beverages
Diet Quality: Sugar-Sweetened Beverage Consumption2.5 ± 1.80.1 ± 0.30.2 ± 2.5
SecondaryPreference 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.

Time frame:
12 Month
Reported as:
Median · Sample number
Preference for Sweet Taste
Sample numberSugar-Sweetened BeveragesArtificially-sweetened BeveragesUnsweetened Beverages
Preference for Sweet Taste6 (5 to 7)6 (4.5 to 7)5 (4 to 6)

Adverse events

Collected over 1 year. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Group 1—2/67 (3%)0/67 (0%)
Group 2—1/67 (1.5%)0/67 (0%)
Group 3—0/69 (0%)0/69 (0%)
Most frequent serious events
Most frequent serious events
EventGroup 1Group 2Group 3
Body AchesMusculoskeletal and connective tissue disorders1/670/670/69
AsthmaRespiratory, thoracic and mediastinal disorders1/670/670/69
Headaches and mood swings due to toothacheNervous system disorders0/671/670/69

Baseline characteristics

Age, Categorical
Age, Categorical(Participants)Sugar-Sweetened BeveragesArtificially-Sweetened BeveragesUnsweetened BeveragesTotal
<=18 years0000
Between 18 and 65 years676769203
>=65 years0000
Age, Continuous
Age, Continuous(years)Sugar-Sweetened BeveragesArtificially-Sweetened BeveragesUnsweetened BeveragesTotal
Mean25.9 ± 5.126.7 ± 5.728.0 ± 6.026.9 ± 5.7
Sex: Female, Male
Sex: Female, Male(Participants)Sugar-Sweetened BeveragesArtificially-Sweetened BeveragesUnsweetened BeveragesTotal
Female274041108
Male40272895
Region of Enrollment
Region of Enrollment(Participants)Sugar-Sweetened BeveragesArtificially-Sweetened BeveragesUnsweetened BeveragesTotal
United States676769203
Ratio of Serum Triglyceride to HDL-cholesterol Concentration (TG:HDLC)
Ratio of Serum Triglyceride to HDL-cholesterol Concentration (TG:HDLC)(ratio of Triglycerides-to-HDL)Sugar-Sweetened BeveragesArtificially-Sweetened BeveragesUnsweetened BeveragesTotal
Mean1.37 (0.87 to 2.16)1.30 (0.78 to 1.98)1.51 (1.08 to 2.51)1.37 (0.90 to 2.17)
LDL-C
LDL-C(mg/dL)Sugar-Sweetened BeveragesArtificially-Sweetened BeveragesUnsweetened BeveragesTotal
Mean100 ± 27102 ± 28110 ± 33104 ± 30
hsCRP
hsCRP(mg/L)Sugar-Sweetened BeveragesArtificially-Sweetened BeveragesUnsweetened BeveragesTotal
Median0.62 (0.32 to 1.84)0.77 (0.34 to 2.30)0.73 (0.43 to 1.38)0.69 (0.34 to 2.08)
Fibrinogen
Fibrinogen(mg/dL)Sugar-Sweetened BeveragesArtificially-Sweetened BeveragesUnsweetened BeveragesTotal
Mean241 ± 64241 ± 74250 ± 71244 ± 70

7 further baseline measures are reported on the registry.

08

Study locations

1 site
  • Children's Hospital Boston
    Boston, Massachusetts 02115, United States
09

References and documents

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 16510646 ↗
  • Ebbeling 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 22998339 ↗
  • Ebbeling 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 ↗

Individual participant data

Plan to share: No

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 27, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT01295671
Lead sponsor
Boston Children's Hospital
Collaborators
National Heart, Lung, and Blood Institute (NHLBI)
Responsible party
David S. Ludwig, MD, PhD (Director, Obesity Prevention Center, Boston Children's Hospital) — Principal investigator
First posted
Feb 14, 2011
Start date
Feb 2011
Primary completion
Nov 2015
Completion
Nov 2015
Results posted
Mar 27, 2018
Last update
Mar 27, 2018

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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