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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
Enrollment 203
Recruitment Details 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 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.
Arm/Group Title Sugar-Sweetened Beverages Artificially-sweetened Beverages Unsweetened Beverages
Hide Arm/Group Description

Provision of beverages: Sugar-sweetened beverages

Provision of beverages: Home delivery of specified beverage type

Provision of beverages: Artificially-sweetened beverages

Provision of beverages: Home delivery of specified beverage type

Provision of beverages: Unsweetened beverages

Provision of beverages: Home delivery of specified beverage type

Period Title: Overall Study
Started 67 67 69
Completed 60 60 66
Not Completed 7 7 3
Reason Not Completed
Lost to Follow-up             4             6             3
Withdrawal by Subject             3             1             0
Arm/Group Title Sugar-Sweetened Beverages Artificially-Sweetened Beverages Unsweetened Beverages Total
Hide Arm/Group Description

Sugar-sweetened beverages

Provision of beverages: Home delivery of specified beverage type

Artificially-sweetened beverages

Provision of beverages: Home delivery of specified beverage type

Unsweetened beverages

Provision of beverages: Home delivery of specified beverage type

Total of all reporting groups
Overall Number of Baseline Participants 67 67 69 203
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 67 participants 67 participants 69 participants 203 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, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 67 participants 67 participants 69 participants 203 participants
25.9  (5.1) 26.7  (5.7) 28.0  (6.0) 26.9  (5.7)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 67 participants 67 participants 69 participants 203 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  
Measure Type: Count of Participants
Unit of measure:  Participants
United States Number Analyzed 67 participants 67 participants 69 participants 203 participants
67
 100.0%
67
 100.0%
69
 100.0%
203
 100.0%
Ratio of Serum Triglyceride to HDL-cholesterol Concentration (TG:HDLC)  
Mean (Inter-Quartile Range)
Unit of measure:  Ratio of Triglycerides-to-HDL
Number Analyzed 67 participants 67 participants 69 participants 203 participants
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  
Mean (Standard Deviation)
Unit of measure:  mg/dL
Number Analyzed 67 participants 67 participants 69 participants 203 participants
100  (27) 102  (28) 110  (33) 104  (30)
hsCRP  
Median (Inter-Quartile Range)
Unit of measure:  mg/L
Number Analyzed 67 participants 67 participants 69 participants 203 participants
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  
Mean (Standard Deviation)
Unit of measure:  mg/dL
Number Analyzed 67 participants 67 participants 69 participants 203 participants
241  (64) 241  (74) 250  (71) 244  (70)
Uric Acid  
Mean (Standard Deviation)
Unit of measure:  mg/dL
Number Analyzed 67 participants 67 participants 69 participants 203 participants
5.3  (1.3) 5.2  (1.4) 5.3  (1.5) 5.3  (1.4)
ALT  
Median (Inter-Quartile Range)
Unit of measure:  U/L
Number Analyzed 67 participants 67 participants 69 participants 203 participants
14
(12 to 21)
18
(13 to 27)
16
(13 to 22)
16
(13 to 22)
Systolic Blood Pressure  
Mean (Standard Deviation)
Unit of measure:  mmHg
Number Analyzed 67 participants 67 participants 69 participants 203 participants
108  (9) 109  (13) 106  (10) 108  (11)
Diastolic Blood Pressure  
Mean (Standard Deviation)
Unit of measure:  mmHg
Number Analyzed 67 participants 67 participants 69 participants 203 participants
67  (8) 67  (8) 68  (7) 67  (8)
Body Weight  
Mean (Standard Deviation)
Unit of measure:  Kg
Number Analyzed 67 participants 67 participants 69 participants 203 participants
75.5  (15.6) 76.8  (16.7) 77.5  (16.1) 76.6  (16.1)
Diet Quality: Sugar-Sweetened Beverage Consumption  
Mean (Standard Deviation)
Unit of measure:  Servings per day
Number Analyzed 67 participants 67 participants 69 participants 203 participants
1.4  (1.1) 1.5  (1.4) 1.8  (1.3) 1.6  (1.3)
Preference for sweet taste   [1] 
Median (Inter-Quartile Range)
Unit of measure:  Sample number
Number Analyzed 67 participants 67 participants 69 participants 203 participants
6
(5 to 7)
6
(5 to 8)
7
(5 to 7)
6
(5 to 8)
[1]
Measure Description: 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.
1.Primary Outcome
Title Ratio of Serum Triglyceride to HDL-cholesterol Concentration (TG:HDLC)
Hide Description [Not Specified]
Time Frame 12 Month
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Sugar-Sweetened Beverages Artificially-sweetened Beverages Unsweetened Beverages
Hide Arm/Group Description:

Provision of beverages: Sugar-sweetened beverages

Provision of beverages: Home delivery of specified beverage type

Provision of beverages: Artificially-sweetened beverages

Provision of beverages: Home delivery of specified beverage type

Provision of beverages: Unsweetened beverages

Provision of beverages: Home delivery of specified beverage type

Overall Number of Participants Analyzed 60 60 66
Median (Inter-Quartile Range)
Unit of Measure: ratio of Triglycerides-to-HDL
1.46
(0.98 to 2.19)
1.19
(0.86 to 1.87)
1.45
(0.99 to 2.31)
2.Secondary Outcome
Title LDL-C
Hide Description LDL-C
Time Frame 12 Month
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Sugar-Sweetened Beverages Artificially-sweetened Beverages Unsweetened Beverages
Hide Arm/Group Description:

Provision of beverages: Sugar-sweetened beverages

Provision of beverages: Home delivery of specified beverage type

Provision of beverages: Artificially-sweetened beverages

Provision of beverages: Home delivery of specified beverage type

Provision of beverages: Unsweetened beverages

Provision of beverages: Home delivery of specified beverage type

Overall Number of Participants Analyzed 60 60 66
Mean (Standard Deviation)
Unit of Measure: mg/dL
103  (31) 104  (30) 109  (29)
3.Secondary Outcome
Title hsCRP
Hide Description hsCRP
Time Frame 12 Month
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Sugar-Sweetened Beverages Artificially-sweetened Beverages Unsweetened Beverages
Hide Arm/Group Description:

Provision of beverages: Sugar-sweetened beverages

Provision of beverages: Home delivery of specified beverage type

Provision of beverages: Artificially-sweetened beverages

Provision of beverages: Home delivery of specified beverage type

Provision of beverages: Unsweetened beverages

Provision of beverages: Home delivery of specified beverage type

Overall Number of Participants Analyzed 60 60 66
Median (Inter-Quartile Range)
Unit of Measure: mg/L
0.86
(0.39 to 1.80)
0.64
(0.39 to 1.81)
0.85
(0.39 to 1.76)
4.Secondary Outcome
Title Fibrinogen
Hide Description Fibrinogen
Time Frame 12 Month
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Sugar-Sweetened Beverages Artificially-sweetened Beverages Unsweetened Beverages
Hide Arm/Group Description:

Provision of beverages: Sugar-sweetened beverages

Provision of beverages: Home delivery of specified beverage type

Provision of beverages: Artificially-sweetened beverages

Provision of beverages: Home delivery of specified beverage type

Provision of beverages: Unsweetened beverages

Provision of beverages: Home delivery of specified beverage type

Overall Number of Participants Analyzed 60 60 66
Mean (Standard Deviation)
Unit of Measure: mg/dL
244  (49) 248  (62) 236  (73)
5.Secondary Outcome
Title Uric Acid
Hide Description Uric Acid
Time Frame 12 Month
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Sugar-Sweetened Beverages Artificially-sweetened Beverages Unsweetened Beverages
Hide Arm/Group Description:

Provision of beverages: Sugar-sweetened beverages

Provision of beverages: Home delivery of specified beverage type

Provision of beverages: Artificially-sweetened beverages

Provision of beverages: Home delivery of specified beverage type

Provision of beverages: Unsweetened beverages

Provision of beverages: Home delivery of specified beverage type

Overall Number of Participants Analyzed 60 60 66
Mean (Standard Deviation)
Unit of Measure: mg/dL
5.2  (1.3) 5.1  (1.4) 5.4  (1.5)
6.Secondary Outcome
Title ALT
Hide Description ALT
Time Frame 12 Month
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Sugar-Sweetened Beverages Artificially-sweetened Beverages Unsweetened Beverages
Hide Arm/Group Description:

Provision of beverages: Sugar-sweetened beverages

Provision of beverages: Home delivery of specified beverage type

Provision of beverages: Artificially-sweetened beverages

Provision of beverages: Home delivery of specified beverage type

Provision of beverages: Unsweetened beverages

Provision of beverages: Home delivery of specified beverage type

Overall Number of Participants Analyzed 60 60 66
Median (Inter-Quartile Range)
Unit of Measure: U/L
16
(12 to 21)
16
(13 to 23)
17
(11 to 26)
7.Secondary Outcome
Title Systolic Blood Pressure
Hide Description Systolic Blood Pressure
Time Frame 12 Month
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Sugar-Sweetened Beverages Artificially-sweetened Beverages Unsweetened Beverages
Hide Arm/Group Description:

Provision of beverages: Sugar-sweetened beverages

Provision of beverages: Home delivery of specified beverage type

Provision of beverages: Artificially-sweetened beverages

Provision of beverages: Home delivery of specified beverage type

Provision of beverages: Unsweetened beverages

Provision of beverages: Home delivery of specified beverage type

Overall Number of Participants Analyzed 60 60 66
Mean (Standard Deviation)
Unit of Measure: mmHg
109  (10) 107  (11) 106  (9)
8.Secondary Outcome
Title Diastolic Blood Pressure
Hide Description Diastolic Blood Pressure
Time Frame 12 Month
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Sugar-Sweetened Beverages Artificially-sweetened Beverages Unsweetened Beverages
Hide Arm/Group Description:

Provision of beverages: Sugar-sweetened beverages

Provision of beverages: Home delivery of specified beverage type

Provision of beverages: Artificially-sweetened beverages

Provision of beverages: Home delivery of specified beverage type

Provision of beverages: Unsweetened beverages

Provision of beverages: Home delivery of specified beverage type

Overall Number of Participants Analyzed 60 60 66
Mean (Standard Deviation)
Unit of Measure: mmHg
68  (9) 67  (8) 67  (8)
9.Secondary Outcome
Title Body Weight
Hide Description Body Weight
Time Frame 12 Month
Hide Outcome Measure Data
Hide Analysis Population Description
Data missing for 1 subject in ASB group.
Arm/Group Title Sugar-Sweetened Beverages Artificially-sweetened Beverages Unsweetened Beverages
Hide Arm/Group Description:

Provision of beverages: Sugar-sweetened beverages

Provision of beverages: Home delivery of specified beverage type

Provision of beverages: Artificially-sweetened beverages

Provision of beverages: Home delivery of specified beverage type

Provision of beverages: Unsweetened beverages

Provision of beverages: Home delivery of specified beverage type

Overall Number of Participants Analyzed 60 59 66
Mean (Standard Deviation)
Unit of Measure: kg
78.0  (17.4) 76.8  (17.2) 78.3  (17.1)
10.Secondary Outcome
Title Diet Quality: Sugar-Sweetened Beverage Consumption
Hide Description Diet Quality: Sugar-Sweetened Beverage Consumption - servings per day
Time Frame 12 Month
Hide Outcome Measure Data
Hide Analysis Population Description
Data missing for 1 subject in USB group.
Arm/Group Title Sugar-Sweetened Beverages Artificially-sweetened Beverages Unsweetened Beverages
Hide Arm/Group Description:

Provision of beverages: Sugar-sweetened beverages

Provision of beverages: Home delivery of specified beverage type

Provision of beverages: Artificially-sweetened beverages

Provision of beverages: Home delivery of specified beverage type

Provision of beverages: Unsweetened beverages

Provision of beverages: Home delivery of specified beverage type

Overall Number of Participants Analyzed 60 60 65
Mean (Standard Deviation)
Unit of Measure: Servings per day
2.5  (1.8) 0.1  (0.3) 0.2  (2.5)
11.Secondary Outcome
Title Preference for Sweet Taste
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
Data missing for 1 subject in SSB group.
Arm/Group Title Sugar-Sweetened Beverages Artificially-sweetened Beverages Unsweetened Beverages
Hide Arm/Group Description:

Provision of beverages: Sugar-sweetened beverages

Provision of beverages: Home delivery of specified beverage type

Provision of beverages: Artificially-sweetened beverages

Provision of beverages: Home delivery of specified beverage type

Provision of beverages: Unsweetened beverages

Provision of beverages: Home delivery of specified beverage type

Overall Number of Participants Analyzed 59 60 66
Median (Inter-Quartile Range)
Unit of Measure: Sample number
6
(5 to 7)
6
(4.5 to 7)
5
(4 to 6)
Time Frame 1 year
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Group 1 Group 2 Group 3
Hide Arm/Group Description

Sugar-sweetened beverages

Provision of beverages: Home delivery of specified beverage type

Artificially-sweetened beverages

Provision of beverages: Home delivery of specified beverage type

Unsweetened beverages

Provision of beverages: Home delivery of specified beverage type

All-Cause Mortality
Group 1 Group 2 Group 3
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Group 1 Group 2 Group 3
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   2/67 (2.99%)      1/67 (1.49%)      0/69 (0.00%)    
Musculoskeletal and connective tissue disorders       
Body Aches  [1]  1/67 (1.49%)  1 0/67 (0.00%)  0 0/69 (0.00%)  0
Nervous system disorders       
Headaches and mood swings due to toothache  [2]  0/67 (0.00%)  0 1/67 (1.49%)  1 0/69 (0.00%)  0
Respiratory, thoracic and mediastinal disorders       
Asthma  [3]  1/67 (1.49%)  1 0/67 (0.00%)  0 0/69 (0.00%)  0
Indicates events were collected by systematic assessment
[1]
Hospitalized for pain management of a severely pulled muscle in chest.
[2]
Severe headaches and mood swings due to toothache
[3]
Hospitalized for asthma
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Group 1 Group 2 Group 3
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/67 (0.00%)      0/67 (0.00%)      0/69 (0.00%)    
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
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