Cardiovascular Disease, Obesity
Conditions
Brief 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.
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.
Interventions
BEHAVIORALProvision of beverages
Home delivery of specified beverage type
Sponsors
National Heart, Lung, and Blood Institute (NHLBI)
Boston Children's Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 40 Years
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
* 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Ratio of Serum Triglyceride to HDL-cholesterol Concentration (TG:HDLC) | 12 Month |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| hsCRP | 12 Month | hsCRP |
| Fibrinogen | 12 Month | Fibrinogen |
| Uric Acid | 12 Month | Uric Acid |
| ALT | 12 Month | ALT |
| LDL-C | 12 Month | LDL-C |
| Diastolic Blood Pressure | 12 Month | Diastolic Blood Pressure |
| Body Weight | 12 Month | Body Weight |
| Diet Quality: Sugar-Sweetened Beverage Consumption | 12 Month | Diet Quality: Sugar-Sweetened Beverage Consumption - servings per day |
| Preference for Sweet Taste | 12 Month | 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. |
| Systolic Blood Pressure | 12 Month | Systolic Blood Pressure |
Countries
United States
Participant flow
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.
Participants by arm
| Arm | Count |
|---|---|
| Sugar-Sweetened Beverages Sugar-sweetened beverages
Provision of beverages: Home delivery of specified beverage type | 67 |
| Artificially-Sweetened Beverages Artificially-sweetened beverages
Provision of beverages: Home delivery of specified beverage type | 67 |
| Unsweetened Beverages Unsweetened beverages
Provision of beverages: Home delivery of specified beverage type | 69 |
| Total | 203 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Lost to Follow-up | 4 | 6 | 3 |
| Overall Study | Withdrawal by Subject | 3 | 1 | 0 |
Baseline characteristics
| Characteristic | Sugar-Sweetened Beverages | Artificially-Sweetened Beverages | Unsweetened Beverages | Total |
|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 67 Participants | 67 Participants | 69 Participants | 203 Participants |
| Age, Continuous | 25.9 years STANDARD_DEVIATION 5.1 | 26.7 years STANDARD_DEVIATION 5.7 | 28.0 years STANDARD_DEVIATION 6 | 26.9 years STANDARD_DEVIATION 5.7 |
| ALT | 14 U/L | 18 U/L | 16 U/L | 16 U/L |
| Body Weight | 75.5 kg STANDARD_DEVIATION 15.6 | 76.8 kg STANDARD_DEVIATION 16.7 | 77.5 kg STANDARD_DEVIATION 16.1 | 76.6 kg STANDARD_DEVIATION 16.1 |
| Diastolic Blood Pressure | 67 mmHg STANDARD_DEVIATION 8 | 67 mmHg STANDARD_DEVIATION 8 | 68 mmHg STANDARD_DEVIATION 7 | 67 mmHg STANDARD_DEVIATION 8 |
| Diet Quality: Sugar-Sweetened Beverage Consumption | 1.4 Servings per day STANDARD_DEVIATION 1.1 | 1.5 Servings per day STANDARD_DEVIATION 1.4 | 1.8 Servings per day STANDARD_DEVIATION 1.3 | 1.6 Servings per day STANDARD_DEVIATION 1.3 |
| Fibrinogen | 241 mg/dL STANDARD_DEVIATION 64 | 241 mg/dL STANDARD_DEVIATION 74 | 250 mg/dL STANDARD_DEVIATION 71 | 244 mg/dL STANDARD_DEVIATION 70 |
| hsCRP | 0.62 mg/L | 0.77 mg/L | 0.73 mg/L | 0.69 mg/L |
| LDL-C | 100 mg/dL STANDARD_DEVIATION 27 | 102 mg/dL STANDARD_DEVIATION 28 | 110 mg/dL STANDARD_DEVIATION 33 | 104 mg/dL STANDARD_DEVIATION 30 |
| Preference for sweet taste | 6 Sample number | 6 Sample number | 7 Sample number | 6 Sample number |
| Ratio of Serum Triglyceride to HDL-cholesterol Concentration (TG:HDLC) | 1.37 ratio of Triglycerides-to-HDL | 1.30 ratio of Triglycerides-to-HDL | 1.51 ratio of Triglycerides-to-HDL | 1.37 ratio of Triglycerides-to-HDL |
| Region of Enrollment United States | 67 Participants | 67 Participants | 69 Participants | 203 Participants |
| Sex: Female, Male Female | 27 Participants | 40 Participants | 41 Participants | 108 Participants |
| Sex: Female, Male Male | 40 Participants | 27 Participants | 28 Participants | 95 Participants |
| Systolic Blood Pressure | 108 mmHg STANDARD_DEVIATION 9 | 109 mmHg STANDARD_DEVIATION 13 | 106 mmHg STANDARD_DEVIATION 10 | 108 mmHg STANDARD_DEVIATION 11 |
| Uric Acid | 5.3 mg/dL STANDARD_DEVIATION 1.3 | 5.2 mg/dL STANDARD_DEVIATION 1.4 | 5.3 mg/dL STANDARD_DEVIATION 1.5 | 5.3 mg/dL STANDARD_DEVIATION 1.4 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 0 / 67 | 0 / 67 | 0 / 69 |
| serious Total, serious adverse events | 2 / 67 | 1 / 67 | 0 / 69 |
Outcome results
Primary
Ratio of Serum Triglyceride to HDL-cholesterol Concentration (TG:HDLC)
Time frame: 12 Month
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Sugar-Sweetened Beverages | Ratio of Serum Triglyceride to HDL-cholesterol Concentration (TG:HDLC) | 1.46 ratio of Triglycerides-to-HDL |
| Artificially-sweetened Beverages | Ratio of Serum Triglyceride to HDL-cholesterol Concentration (TG:HDLC) | 1.19 ratio of Triglycerides-to-HDL |
| Unsweetened Beverages | Ratio of Serum Triglyceride to HDL-cholesterol Concentration (TG:HDLC) | 1.45 ratio of Triglycerides-to-HDL |
Secondary
ALT
ALT
Time frame: 12 Month
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Sugar-Sweetened Beverages | ALT | 16 U/L |
| Artificially-sweetened Beverages | ALT | 16 U/L |
| Unsweetened Beverages | ALT | 17 U/L |
Secondary
Body Weight
Body Weight
Time frame: 12 Month
Population: Data missing for 1 subject in ASB group.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Sugar-Sweetened Beverages | Body Weight | 78.0 kg | Standard Deviation 17.4 |
| Artificially-sweetened Beverages | Body Weight | 76.8 kg | Standard Deviation 17.2 |
| Unsweetened Beverages | Body Weight | 78.3 kg | Standard Deviation 17.1 |
Secondary
Diastolic Blood Pressure
Diastolic Blood Pressure
Time frame: 12 Month
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Sugar-Sweetened Beverages | Diastolic Blood Pressure | 68 mmHg | Standard Deviation 9 |
| Artificially-sweetened Beverages | Diastolic Blood Pressure | 67 mmHg | Standard Deviation 8 |
| Unsweetened Beverages | Diastolic Blood Pressure | 67 mmHg | Standard Deviation 8 |
Secondary
Diet Quality: Sugar-Sweetened Beverage Consumption
Diet Quality: Sugar-Sweetened Beverage Consumption - servings per day
Time frame: 12 Month
Population: Data missing for 1 subject in USB group.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Sugar-Sweetened Beverages | Diet Quality: Sugar-Sweetened Beverage Consumption | 2.5 Servings per day | Standard Deviation 1.8 |
| Artificially-sweetened Beverages | Diet Quality: Sugar-Sweetened Beverage Consumption | 0.1 Servings per day | Standard Deviation 0.3 |
| Unsweetened Beverages | Diet Quality: Sugar-Sweetened Beverage Consumption | 0.2 Servings per day | Standard Deviation 2.5 |
Secondary
Fibrinogen
Fibrinogen
Time frame: 12 Month
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Sugar-Sweetened Beverages | Fibrinogen | 244 mg/dL | Standard Deviation 49 |
| Artificially-sweetened Beverages | Fibrinogen | 248 mg/dL | Standard Deviation 62 |
| Unsweetened Beverages | Fibrinogen | 236 mg/dL | Standard Deviation 73 |
Secondary
hsCRP
hsCRP
Time frame: 12 Month
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Sugar-Sweetened Beverages | hsCRP | 0.86 mg/L |
| Artificially-sweetened Beverages | hsCRP | 0.64 mg/L |
| Unsweetened Beverages | hsCRP | 0.85 mg/L |
Secondary
LDL-C
LDL-C
Time frame: 12 Month
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Sugar-Sweetened Beverages | LDL-C | 103 mg/dL | Standard Deviation 31 |
| Artificially-sweetened Beverages | LDL-C | 104 mg/dL | Standard Deviation 30 |
| Unsweetened Beverages | LDL-C | 109 mg/dL | Standard Deviation 29 |
Secondary
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
Population: Data missing for 1 subject in SSB group.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Sugar-Sweetened Beverages | Preference for Sweet Taste | 6 Sample number |
| Artificially-sweetened Beverages | Preference for Sweet Taste | 6 Sample number |
| Unsweetened Beverages | Preference for Sweet Taste | 5 Sample number |
Secondary
Systolic Blood Pressure
Systolic Blood Pressure
Time frame: 12 Month
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Sugar-Sweetened Beverages | Systolic Blood Pressure | 109 mmHg | Standard Deviation 10 |
| Artificially-sweetened Beverages | Systolic Blood Pressure | 107 mmHg | Standard Deviation 11 |
| Unsweetened Beverages | Systolic Blood Pressure | 106 mmHg | Standard Deviation 9 |
Secondary
Uric Acid
Uric Acid
Time frame: 12 Month
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Sugar-Sweetened Beverages | Uric Acid | 5.2 mg/dL | Standard Deviation 1.3 |
| Artificially-sweetened Beverages | Uric Acid | 5.1 mg/dL | Standard Deviation 1.4 |
| Unsweetened Beverages | Uric Acid | 5.4 mg/dL | Standard Deviation 1.5 |