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This study aims to 1) assess the feasibility and acceptability of a prescribed beverage intervention in 50 obese Hispanic adults ages 18-64 years over 6 weeks; and 2) assess preliminary effects of the beverage intervention on cholesterol and triglyceride levels as well as other markers of health such as blood pressure, glucose and markers of inflammation. This project, if successful, will provide early evidence that targeting dietary behavior around beverage intake could be a novel and easily adopted approach to reduce the burden or delay the onset of metabolic abnormalities in obese Hispanic adults. The expected outcome of the proposed project is the identification of feasible and appropriate beverage intervention strategies to improve engagement and adherence to dietary modification approaches for control of metabolic health indicators in this vulnerable ethnic group.
In the U.S., Hispanics have the highest rates of overweight and obesity when compared to other racial/ethnic groups placing them at a greater risk for obesity-related disease. Yet, current literature is limited to information on best practices to engage Hispanics in health-promoting lifestyle interventions. Without this information the health consequences associated with obesity, including high blood pressure, elevated blood glucose and high cholesterol, will continue. Evidence exists to support diet-specific behavioral interventions in reducing obesity-related health risks. Among the more adoptable interventions to date are efforts targeting beverage intake. Yet, there are limited data to suggest these approaches are effective for Hispanics despite this being the fastest growing and highest burdened group for obesity-related disease within the U.S. population.
This study aims to 1) assess the feasibility and acceptability of a prescribed beverage intervention in 50 obese Hispanic adults ages 18-64 years over 6 weeks; 2) assess preliminary effects of the beverage intervention on cholesterol and triglyceride levels as well as other markers of health such as blood pressure, glucose and markers of inflammation. This project, if successful, will provide early evidence that targeting dietary behavior around beverage intake could be a novel and easily adopted approach to reduce the burden or delay the onset of metabolic abnormalities in obese Hispanic adults. The expected outcome of the proposed project is the identification of feasible and appropriate beverage intervention strategies to improve engagement and adherence to dietary modification approaches for control of metabolic health indicators in this vulnerable ethnic group.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Mediterranean Lemonade Consumption | Experimental | All participants will be asked to consume 32 ounces daily of Mediterranean Lemonade. The beverage will be previously prepared and packaged by study personnel. Participants will receive their beverage supply on a weekly basis for a total of six weeks. |
|
| Green Tea Consumption | Experimental | All participants will be asked to consume 32 ounces daily of Green Tea. The beverage will be previously prepared and packaged by study personnel. Participants will receive their beverage supply on a weekly basis for a total of six weeks. |
|
| Flavored Water Consumption | Placebo Comparator | All participants will be asked to consume 32 ounces daily of Flavored Water. The beverage will be previously prepared and packaged by study personnel. Participants will receive their beverage supply on a weekly basis for a total of six weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mediterranean Lemonade | Other | All participants will be advised to consume all of the beverage assigned (mediterranean lemonade) on a daily basis (rather than save up and consume large amounts on fewer days). The beverages will be prepared in advance by study personnel, refrigerated, and distributed to study participants on a weekly basis. Participants will be provided a daily 32-ounce beverage container for beverage consumption and instructed to clean the container nightly. Participants will also be asked to keep a log of completion of beverage on a daily basis and instructions regarding intake of other beverages will be provided. |
| Measure | Description | Time Frame |
|---|---|---|
| Study Recruitment: Interest in Participation | The number of Hispanic adults who contact the researchers and express interest in participation. | Baseline |
| Study Recruitment: Screened for Eligibility | The number of Hispanic adults screened for eligibility | Baseline |
| Study Recruitment: Eligibility | The number of Hispanic adults eligible for study inclusion. | Baseline |
| Study Recruitment: Ineligibility | The number of Hispanic adults ineligible for study inclusion. | Baseline |
| Enrollment | The number of Hispanic adults enrolled in the study. | Baseline |
| Retention | Retention will be measured as the number of participants who remain in the study at 6 weeks. | Week 6 |
| Treatment Satisfaction | Participants will be asked to rate their overall satisfaction (1- low; 4-high) with the intervention for changing dietary patterns at Week 6 and if they would recommend the program to others. | Week 6 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Total Cholesterol (Baseline and Week 6) | Fasting blood samples (venipuncture) will be collected for the purpose of examining changes in total cholesterol. | Baseline and Week 6 |
| Change in Fasting Glucose (Baseline and Week 6) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| David O Garcia, PhD | University of Arizona | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Arizona Collaboratory for Metabolic Disease Prevention and Treatment | Tucson | Arizona | 85714 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24570244 | Background | Ogden CL, Carroll MD, Kit BK, Flegal KM. Prevalence of childhood and adult obesity in the United States, 2011-2012. JAMA. 2014 Feb 26;311(8):806-14. doi: 10.1001/jama.2014.732. | |
| 21715508 | Background | Zheng XX, Xu YL, Li SH, Liu XX, Hui R, Huang XH. Green tea intake lowers fasting serum total and LDL cholesterol in adults: a meta-analysis of 14 randomized controlled trials. Am J Clin Nutr. 2011 Aug;94(2):601-10. doi: 10.3945/ajcn.110.010926. Epub 2011 Jun 29. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Mediterranean Lemonade Consumption | All participants will be asked to consume 32 ounces daily of Mediterranean Lemonade. The beverage will be previously prepared and packaged by study personnel. Participants will receive their beverage supply on a weekly basis for a total of six weeks. Mediterranean Lemonade: All participants will be advised to consume all of the beverage assigned (mediterranean lemonade) on a daily basis (rather than save up and consume large amounts on fewer days). The beverages will be prepared in advance by study personnel, refrigerated, and distributed to study participants on a weekly basis. Participants will be provided a daily 32-ounce beverage container for beverage consumption and instructed to clean the container nightly. Participants will also be asked to keep a log of completion of beverage on a daily basis and instructions regarding intake of other beverages will be provided. |
| FG001 | Green Tea Consumption | All participants will be asked to consume 32 ounces daily of Green Tea. The beverage will be previously prepared and packaged by study personnel. Participants will receive their beverage supply on a weekly basis for a total of six weeks. Green Tea: All participants will be advised to consume all of the beverage assigned (green tea) on a daily basis (rather than save up and consume large amounts on fewer days). The beverages will be prepared in advance by study personnel, refrigerated, and distributed to study participants on a weekly basis. Participants will be provided a daily 32-ounce beverage container for beverage consumption and instructed to clean the container nightly. Participants will also be asked to keep a log of completion of beverage on a daily basis and instructions regarding intake of other beverages will be provided. |
| FG002 | Flavored Water Consumption | All participants will be asked to consume 32 ounces daily of Flavored Water. The beverage will be previously prepared and packaged by study personnel. Participants will receive their beverage supply on a weekly basis for a total of six weeks. Flavored Water: All participants will be advised to consume all of the beverage assigned (flavored water) on a daily basis (rather than save up and consume large amounts on fewer days). The beverages will be prepared in advance by study personnel, refrigerated, and distributed to study participants on a weekly basis. Participants will be provided a daily 32-ounce beverage container for beverage consumption and instructed to clean the container nightly. Participants will also be asked to keep a log of completion of beverage on a daily basis and instructions regarding intake of other beverages will be provided. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Flavored Water | All participants were advised to consume all of the beverage assigned (flavored water) on a daily basis (rather than save up and consume large amounts on fewer days). The beverages were prepared in advance by study personnel, refrigerated, and distributed to study participants on a weekly basis. Participants were provided a daily 32-ounce beverage container for beverage consumption and instructed to clean the container nightly. Participants were asked to keep a log of completion of beverage on a daily basis and instructions regarding intake of other beverages were provided. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Study Recruitment: Interest in Participation | The number of Hispanic adults who contact the researchers and express interest in participation. | Posted | Count of Participants | Participants | Baseline |
|
|
1 year (August 2016-August 2017)
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Mediterranean Lemonade Consumption | All participants will be asked to consume 32 ounces daily of Mediterranean Lemonade. The beverage will be previously prepared and packaged by study personnel. Participants will receive their beverage supply on a weekly basis for a total of six weeks. Mediterranean Lemonade: All participants will be advised to consume all of the beverage assigned (mediterranean lemonade) on a daily basis (rather than save up and consume large amounts on fewer days). The beverages will be prepared in advance by study personnel, refrigerated, and distributed to study participants on a weekly basis. Participants will be provided a daily 32-ounce beverage container for beverage consumption and instructed to clean the container nightly. Participants will also be asked to keep a log of completion of beverage on a daily basis and instructions regarding intake of other beverages will be provided. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Gastrointestinal Distress | Gastrointestinal disorders | GI Distress | Systematic Assessment |
The study was short in duration. It is possible that this was not an adequate amount of time to observe changes in our primary outcomes. In addition, the small sample size may have reduced effect size, thus hindering our capacity to detect changes.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| David O. Garcia, PhD, FACSM | University of Arizona | 520-626-4641 | davidogarcia@email.arizona.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Nov 1, 2017 | Jun 15, 2019 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D009765 | Obesity |
| D006937 | Hypercholesterolemia |
| D006943 | Hyperglycemia |
| D015228 | Hypertriglyceridemia |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D013662 | Tea |
| ID | Term |
|---|---|
| D028321 | Plant Preparations |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
| D001628 | Beverages |
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|
|
| Green Tea | Other | All participants will be advised to consume all of the beverage assigned (green tea) on a daily basis (rather than save up and consume large amounts on fewer days). The beverages will be prepared in advance by study personnel, refrigerated, and distributed to study participants on a weekly basis. Participants will be provided a daily 32-ounce beverage container for beverage consumption and instructed to clean the container nightly. Participants will also be asked to keep a log of completion of beverage on a daily basis and instructions regarding intake of other beverages will be provided. |
|
|
| Flavored Water | Other | All participants will be advised to consume all of the beverage assigned (flavored water) on a daily basis (rather than save up and consume large amounts on fewer days). The beverages will be prepared in advance by study personnel, refrigerated, and distributed to study participants on a weekly basis. Participants will be provided a daily 32-ounce beverage container for beverage consumption and instructed to clean the container nightly. Participants will also be asked to keep a log of completion of beverage on a daily basis and instructions regarding intake of other beverages will be provided. |
|
|
Fasting blood samples (venipuncture) will be collected for the purpose of examining changes in glucose.
| Baseline and Week 6 |
| Change in Hemoglobin A1C (Baseline and Week 6) | Fasting blood samples (venipuncture) were collected for the purpose of examining changes in hemoglobin A1C. | Baseline and Week 6 |
| Change in Body Weight (Baseline and Week 6) | Body weight was measured on a digital scale to assess change in body weight over the intervention period. | Baseline and Week 6 |
| 11401918 | Background | Hakim IA, Hartz V, Harris RB, Balentine D, Weisgerber UM, Graver E, Whitacre R, Alberts D. Reproducibility and relative validity of a questionnaire to assess intake of black tea polyphenols in epidemiological studies. Cancer Epidemiol Biomarkers Prev. 2001 Jun;10(6):667-78. |
| 30451147 | Derived | Garcia DO, Morrill KE, Aceves B, Valdez LA, Rabe BA, Bell ML, Hakim IA, Martinez JA, Thomson CA. Feasibility and acceptability of a beverage intervention for Hispanic adults: results from a pilot randomized controlled trial. Public Health Nutr. 2019 Mar;22(3):542-552. doi: 10.1017/S1368980018003051. Epub 2018 Nov 19. |
| 29426328 | Derived | Morrill KE, Aceves B, Valdez LA, Thomson CA, Hakim IA, Bell ML, Martinez JA, Garcia DO. Feasibility and acceptability of a beverage intervention for Hispanic adults: a protocol for a pilot randomized controlled trial. Nutr J. 2018 Feb 9;17(1):16. doi: 10.1186/s12937-018-0329-y. |
| BG001 | Mediterranean Lemonade | All participants were advised to consume all of the beverage assigned (Mediterranean lemonade) on a daily basis (rather than save up and consume large amounts on fewer days). The beverages were prepared in advance by study personnel, refrigerated, and distributed to study participants on a weekly basis. Participants were provided a daily 32-ounce beverage container for beverage consumption and instructed to clean the container nightly. Participants were asked to keep a log of completion of beverage on a daily basis and instructions regarding intake of other beverages were provided. |
| BG002 | Green Tea | All participants were advised to consume all of the beverage assigned (green tea) on a daily basis (rather than save up and consume large amounts on fewer days). The beverages were prepared in advance by study personnel, refrigerated, and distributed to study participants on a weekly basis. Participants were provided a daily 32-ounce beverage container for beverage consumption and instructed to clean the container nightly. Participants were asked to keep a log of completion of beverage on a daily basis and instructions regarding intake of other beverages were provided. |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants | No |
|
| Total Cholesterol | Mean | Standard Deviation | mg/dl |
|
| Fasting Glucose | Mean | Standard Deviation | mg/dl |
|
| Hemoglobin A1C | Mean | Standard Deviation | % of Hemoglobin A1C |
|
| Body Weight | Mean | Standard Deviation | kg |
|
|
| Primary | Study Recruitment: Screened for Eligibility | The number of Hispanic adults screened for eligibility | Posted | Count of Participants | Participants | Baseline |
|
|
|
| Primary | Study Recruitment: Eligibility | The number of Hispanic adults eligible for study inclusion. | Posted | Count of Participants | Participants | Baseline |
|
|
|
| Primary | Study Recruitment: Ineligibility | The number of Hispanic adults ineligible for study inclusion. | Posted | Count of Participants | Participants | Baseline |
|
|
|
| Primary | Enrollment | The number of Hispanic adults enrolled in the study. | Posted | Count of Participants | Participants | Baseline |
|
|
|
| Primary | Retention | Retention will be measured as the number of participants who remain in the study at 6 weeks. | Posted | Count of Participants | Participants | Week 6 |
|
|
|
| Primary | Treatment Satisfaction | Participants will be asked to rate their overall satisfaction (1- low; 4-high) with the intervention for changing dietary patterns at Week 6 and if they would recommend the program to others. | Posted | Mean | Standard Deviation | units on a scale | Week 6 |
|
|
|
| Secondary | Change in Total Cholesterol (Baseline and Week 6) | Fasting blood samples (venipuncture) will be collected for the purpose of examining changes in total cholesterol. | Posted | Mean | 95% Confidence Interval | mg/dl | Baseline and Week 6 |
|
|
|
| Secondary | Change in Fasting Glucose (Baseline and Week 6) | Fasting blood samples (venipuncture) will be collected for the purpose of examining changes in glucose. | Posted | Mean | 95% Confidence Interval | mg/dl | Baseline and Week 6 |
|
|
|
| Secondary | Change in Hemoglobin A1C (Baseline and Week 6) | Fasting blood samples (venipuncture) were collected for the purpose of examining changes in hemoglobin A1C. | Posted | Mean | 95% Confidence Interval | % of Hemoglobin A1C | Baseline and Week 6 |
|
|
|
| Secondary | Change in Body Weight (Baseline and Week 6) | Body weight was measured on a digital scale to assess change in body weight over the intervention period. | Posted | Mean | 95% Confidence Interval | kg | Baseline and Week 6 |
|
|
|
| 0 |
| 21 |
| 0 |
| 21 |
| 2 |
| 21 |
| EG001 | Green Tea Consumption | All participants will be asked to consume 32 ounces daily of Green Tea. The beverage will be previously prepared and packaged by study personnel. Participants will receive their beverage supply on a weekly basis for a total of six weeks. Green Tea: All participants will be advised to consume all of the beverage assigned (green tea) on a daily basis (rather than save up and consume large amounts on fewer days). The beverages will be prepared in advance by study personnel, refrigerated, and distributed to study participants on a weekly basis. Participants will be provided a daily 32-ounce beverage container for beverage consumption and instructed to clean the container nightly. Participants will also be asked to keep a log of completion of beverage on a daily basis and instructions regarding intake of other beverages will be provided. | 0 | 19 | 0 | 19 | 0 | 19 |
| EG002 | Flavored Water Consumption | All participants will be asked to consume 32 ounces daily of Flavored Water. The beverage will be previously prepared and packaged by study personnel. Participants will receive their beverage supply on a weekly basis for a total of six weeks. Flavored Water: All participants will be advised to consume all of the beverage assigned (flavored water) on a daily basis (rather than save up and consume large amounts on fewer days). The beverages will be prepared in advance by study personnel, refrigerated, and distributed to study participants on a weekly basis. Participants will be provided a daily 32-ounce beverage container for beverage consumption and instructed to clean the container nightly. Participants will also be asked to keep a log of completion of beverage on a daily basis and instructions regarding intake of other beverages will be provided. | 0 | 10 | 0 | 10 | 0 | 10 |
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| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D006949 | Hyperlipidemias |
| D050171 | Dyslipidemias |
| D052439 | Lipid Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D044882 | Glucose Metabolism Disorders |
| D000066888 |
| Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
| D019602 | Food and Beverages |