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Beverages and Societal Health (BASH III)

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ClinicalTrials.gov Identifier: NCT01295671
Recruitment Status : Completed
First Posted : February 14, 2011
Results First Posted : March 27, 2018
Last Update Posted : March 27, 2018
Sponsor:
Collaborator:
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
David S. Ludwig, MD, PhD, Boston Children’s Hospital

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Outcomes Assessor);   Primary Purpose: Treatment
Condition: Cardiovascular Disease, Obesity
Intervention: Behavioral: Provision of beverages

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Subjects were recruited from the Boston metro area via multiple recruitment methods (i.e., print media, social media) from February 2011 through October 2014.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
3607 participants were initially telephone screened; 1462 were eligible after telephone screening; 407 were eligible after an Informational Visit; 222 provided informed consent; 19 withdrew or were found ineligible prior to completing baseline assessments. 203 participants completed baseline assessments and were randomized.

Reporting Groups
  Description
Sugar-Sweetened Beverages

Provision of beverages: Sugar-sweetened beverages

Provision of beverages: Home delivery of specified beverage type

Artificially-sweetened Beverages

Provision of beverages: Artificially-sweetened beverages

Provision of beverages: Home delivery of specified beverage type

Unsweetened Beverages

Provision of beverages: Unsweetened beverages

Provision of beverages: Home delivery of specified beverage type


Participant Flow:   Overall Study
    Sugar-Sweetened Beverages   Artificially-sweetened Beverages   Unsweetened Beverages
STARTED   67   67   69 
COMPLETED   60   60   66 
NOT COMPLETED   7   7   3 
Lost to Follow-up                4                6                3 
Withdrawal by Subject                3                1                0 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Sugar-Sweetened Beverages

Sugar-sweetened beverages

Provision of beverages: Home delivery of specified beverage type

Artificially-Sweetened Beverages

Artificially-sweetened beverages

Provision of beverages: Home delivery of specified beverage type

Unsweetened Beverages

Unsweetened beverages

Provision of beverages: Home delivery of specified beverage type

Total Total of all reporting groups

Baseline Measures
   Sugar-Sweetened Beverages   Artificially-Sweetened Beverages   Unsweetened Beverages   Total 
Overall Participants Analyzed 
[Units: Participants]
 67   67   69   203 
Age 
[Units: Participants]
Count of Participants
       
<=18 years      0   0.0%      0   0.0%      0   0.0%      0   0.0% 
Between 18 and 65 years      67 100.0%      67 100.0%      69 100.0%      203 100.0% 
>=65 years      0   0.0%      0   0.0%      0   0.0%      0   0.0% 
Age 
[Units: Years]
Mean (Standard Deviation)
 25.9  (5.1)   26.7  (5.7)   28.0  (6.0)   26.9  (5.7) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
       
Female      27  40.3%      40  59.7%      41  59.4%      108  53.2% 
Male      40  59.7%      27  40.3%      28  40.6%      95  46.8% 
Region of Enrollment 
[Units: Participants]
Count of Participants
       
United States   67   67   69   203 
Ratio of Serum Triglyceride to HDL-cholesterol Concentration (TG:HDLC) 
[Units: Ratio of Triglycerides-to-HDL]
Mean (Inter-Quartile Range)
 1.37 
 (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 
[Units: mg/dL]
Mean (Standard Deviation)
 100  (27)   102  (28)   110  (33)   104  (30) 
hsCRP 
[Units: mg/L]
Median (Inter-Quartile Range)
 0.62 
 (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 
[Units: mg/dL]
Mean (Standard Deviation)
 241  (64)   241  (74)   250  (71)   244  (70) 
Uric Acid 
[Units: mg/dL]
Mean (Standard Deviation)
 5.3  (1.3)   5.2  (1.4)   5.3  (1.5)   5.3  (1.4) 
ALT 
[Units: U/L]
Median (Inter-Quartile Range)
 14 
 (12 to 21) 
 18 
 (13 to 27) 
 16 
 (13 to 22) 
 16 
 (13 to 22) 
Systolic Blood Pressure 
[Units: mmHg]
Mean (Standard Deviation)
 108  (9)   109  (13)   106  (10)   108  (11) 
Diastolic Blood Pressure 
[Units: mmHg]
Mean (Standard Deviation)
 67  (8)   67  (8)   68  (7)   67  (8) 
Body Weight 
[Units: Kg]
Mean (Standard Deviation)
 75.5  (15.6)   76.8  (16.7)   77.5  (16.1)   76.6  (16.1) 
Diet Quality: Sugar-Sweetened Beverage Consumption 
[Units: Servings per day]
Mean (Standard Deviation)
 1.4  (1.1)   1.5  (1.4)   1.8  (1.3)   1.6  (1.3) 
Preference for sweet taste [1] 
[Units: Sample number]
Median (Inter-Quartile Range)
 6 
 (5 to 7) 
 6 
 (5 to 8) 
 7 
 (5 to 7) 
 6 
 (5 to 8) 
[1] 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.


  Outcome Measures

1.  Primary:   Ratio of Serum Triglyceride to HDL-cholesterol Concentration (TG:HDLC)   [ Time Frame: 12 Month ]

2.  Secondary:   LDL-C   [ Time Frame: 12 Month ]

3.  Secondary:   hsCRP   [ Time Frame: 12 Month ]

4.  Secondary:   Fibrinogen   [ Time Frame: 12 Month ]

5.  Secondary:   Uric Acid   [ Time Frame: 12 Month ]

6.  Secondary:   ALT   [ Time Frame: 12 Month ]

7.  Secondary:   Systolic Blood Pressure   [ Time Frame: 12 Month ]

8.  Secondary:   Diastolic Blood Pressure   [ Time Frame: 12 Month ]

9.  Secondary:   Body Weight   [ Time Frame: 12 Month ]

10.  Secondary:   Diet Quality: Sugar-Sweetened Beverage Consumption   [ Time Frame: 12 Month ]

11.  Secondary:   Preference for Sweet Taste   [ Time Frame: 12 Month ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Dr. David Ludwig
Organization: Boston Children's Hospital
phone: 617-355-4878
e-mail: david.ludwig@childrens.harvard.edu


Publications:

Responsible Party: David S. Ludwig, MD, PhD, Boston Children’s Hospital
ClinicalTrials.gov Identifier: NCT01295671     History of Changes
Other Study ID Numbers: 10-06-0242
First Submitted: February 11, 2011
First Posted: February 14, 2011
Results First Submitted: October 19, 2017
Results First Posted: March 27, 2018
Last Update Posted: March 27, 2018