An interventional study of Mediterranean Lemonade and Green Tea in Obesity, Hypercholesterolemia and Hyperglycemia, sponsored by University of Arizona. Completed at 1 site in United States. Open to participants aged 18 Years to 64 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-10-25.
Sponsored by University of Arizona · Not applicable, Interventional, and Treatment
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.
6,570 studies on the registry are indexed under Obesity; 1,718 are open to participants now.
This study's enrollment of 50 is below the median of 77 across 5,084 interventional studies indexed under Obesity.
Browse Obesity studies →University of Arizona is the lead sponsor of 475 studies on the registry; 87 are open to participants now.
Of its 51 completed or terminated interventional studies of FDA-regulated products, 30 (59%) have results posted.
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Exclusion Criteria:
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.
Other: Mediterranean Lemonade
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.
Other: Green Tea
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.
Other: Flavored Water
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.
Also known as: Beverage Consumption Intervention
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.
Also known as: Beverage Consumption Intervention
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.
Also known as: Beverage Consumption Intervention
Study Recruitment: Interest in Participation
The number of Hispanic adults who contact the researchers and express interest in participation.
Time frame: Baseline
Study Recruitment: Screened for Eligibility
The number of Hispanic adults screened for eligibility
Time frame: Baseline
Study Recruitment: Eligibility
The number of Hispanic adults eligible for study inclusion.
Time frame: Baseline
Study Recruitment: Ineligibility
The number of Hispanic adults ineligible for study inclusion.
Time frame: Baseline
Enrollment
The number of Hispanic adults enrolled in the study.
Time frame: Baseline
Retention
Retention will be measured as the number of participants who remain in the study at 6 weeks.
Time frame: 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.
Time frame: Week 6
Change in Total Cholesterol (Baseline and Week 6)
Fasting blood samples (venipuncture) will be collected for the purpose of examining changes in total cholesterol.
Time frame: Baseline and Week 6
Change in Fasting Glucose (Baseline and Week 6)
Fasting blood samples (venipuncture) will be collected for the purpose of examining changes in glucose.
Time frame: 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.
Time frame: 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.
Time frame: Baseline and Week 6
| Milestone | Mediterranean Lemonade Consumption | Green Tea Consumption | Flavored Water Consumption |
|---|---|---|---|
| Started | 21 | 19 | 10 |
| Completed | 18 | 16 | 10 |
| Not completed | 3 | 3 | 0 |
The number of Hispanic adults who contact the researchers and express interest in participation.
| Participants | Interest in Participation. |
|---|---|
| Study Recruitment: Interest in Participation | 279 |
The number of Hispanic adults screened for eligibility
| Participants | Study Recruitment: Screened for Eligibility |
|---|---|
| Study Recruitment: Screened for Eligibility | 236 |
The number of Hispanic adults eligible for study inclusion.
| Participants | Study Recruitment: Eligibility |
|---|---|
| Study Recruitment: Eligibility | 104 |
The number of Hispanic adults ineligible for study inclusion.
| Participants | Study Recruitment: Ineligibility |
|---|---|
| Study Recruitment: Ineligibility | 132 |
The number of Hispanic adults enrolled in the study.
| Participants | Enrollment |
|---|---|
| Enrollment | 52 |
Retention will be measured as the number of participants who remain in the study at 6 weeks.
| Participants | Retention |
|---|---|
| Retention | 44 |
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.
| units on a scale | Treatment Satisfaction Flavored Water | Treatment Satisfaction Mediterranean Lemonade | Treatment Satisfaction Green Tea |
|---|---|---|---|
| Treatment Satisfaction | 3.3 ± 1.1 | 3.4 ± 0.9 | 3.3 ± 1.0 |
Fasting blood samples (venipuncture) will be collected for the purpose of examining changes in total cholesterol.
| mg/dl | Change in Total Cholesterol Flavored Water | Change in Total Cholesterol Mediterranean Lemonade | Change in Total Cholesterol Green Tea |
|---|---|---|---|
| Change in Total Cholesterol (Baseline and Week 6) | -13.2 (-30.2 to 3.8) | -1.67 (-14.2 to 10.9) | -3.9 (-17.2 to 9.4) |
Fasting blood samples (venipuncture) will be collected for the purpose of examining changes in glucose.
| mg/dl | Change in Fasting Glucose Flavored Water | Change in Fasting Glucose Mediterranean Lemonade | Change in Fasting Glucose Green Tea |
|---|---|---|---|
| Change in Fasting Glucose (Baseline and Week 6) | -1.40 (-5.0 to 2.2) | 5.2 (2.6 to 7.9) | 3.3 (0.58 to 6.4) |
Fasting blood samples (venipuncture) were collected for the purpose of examining changes in hemoglobin A1C.
| % of Hemoglobin A1C | Change in Hemoglobin A1C Flavored Water | Change in Hemoglobin A1c Mediterranean Lemonade | Change in Hemoglobin A1c Green Tea |
|---|---|---|---|
| Change in Hemoglobin A1C (Baseline and Week 6) | -0.02 (-0.14 to 0.1) | 0.05 (-0.04 to 0.14) | 0.04 (-0.06 to 0.14) |
Body weight was measured on a digital scale to assess change in body weight over the intervention period.
| kg | Change in Body Weight Flavored Water | Change in Body Weight Mediterranean Lemonade | Change in Body Weight Green Tea |
|---|---|---|---|
| Change in Body Weight (Baseline and Week 6) | -1.8 (-2.9 to -0.55) | -0.12 (-1.0 to 0.8) | -0.36 (-1.6 to 1.8) |
Collected over 1 year (August 2016-August 2017). Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Mediterranean Lemonade Consumption | 0/21 (0%) | 0/21 (0%) | 2/21 (9.5%) |
| Green Tea Consumption | 0/19 (0%) | 0/19 (0%) | 0/19 (0%) |
| Flavored Water Consumption | 0/10 (0%) | 0/10 (0%) | 0/10 (0%) |
| Event | Mediterranean Lemonade Consumption | Green Tea Consumption | Flavored Water Consumption |
|---|---|---|---|
| Gastrointestinal DistressGastrointestinal disorders | 2/21 | 0/19 | 0/10 |
| Age, Continuous(years) | Flavored Water | Mediterranean Lemonade | Green Tea | Total |
|---|---|---|---|---|
| Mean | 39.0 ± 7.1 | 44.5 ± 9.5 | 48.1 ± 10.9 | 44.7 ± 10.1 |
| Sex: Female, Male(Participants) | Flavored Water | Mediterranean Lemonade | Green Tea | Total |
|---|---|---|---|---|
| Female | 8 | 16 | 15 | 39 |
| Male | 2 | 5 | 4 | 11 |
| Race/Ethnicity, Customized(Participants) | Flavored Water | Mediterranean Lemonade | Green Tea | Total |
|---|---|---|---|---|
| Mexican | 4 | 11 | 15 | 30 |
| Mexican-American | 4 | 6 | 3 | 13 |
| South/Central American | 2 | 1 | 0 | 3 |
| Other Spanish, Hispanic, Latino | 0 | 2 | 0 | 2 |
| Missing | 0 | 1 | 1 | 2 |
| Region of Enrollment(Participants) | Flavored Water | Mediterranean Lemonade | Green Tea | Total |
|---|---|---|---|---|
| United States | 10 | 21 | 19 | 50 |
| Total Cholesterol(mg/dl) | Flavored Water | Mediterranean Lemonade | Green Tea | Total |
|---|---|---|---|---|
| Mean | 182.7 ± 31.6 | 190.5 ± 45.3 | 200.1 ± 32.8 | 192.6 ± 38.2 |
| Fasting Glucose(mg/dl) | Flavored Water | Mediterranean Lemonade | Green Tea | Total |
|---|---|---|---|---|
| Mean | 89.8 ± 9.8 | 93.0 ± 12.3 | 93.7 ± 12.3 | 92.6 ± 11.7 |
| Hemoglobin A1C(% of Hemoglobin A1C) | Flavored Water | Mediterranean Lemonade | Green Tea | Total |
|---|---|---|---|---|
| Mean | 5.37 ± 0.28 | 5.52 ± 0.31 | 5.46 ± 0.39 | 5.47 ± 0.34 |
| Body Weight(kg) | Flavored Water | Mediterranean Lemonade | Green Tea | Total |
|---|---|---|---|---|
| Mean | 99.1 ± 27.9 | 97 ± 17.7 | 89.9 ± 15.1 | 94.7 ± 19.2 |
Documents are hosted by the registry — open the source record to download them.
Plan to share: No
Ran from Jun 2016 to primary completion in Aug 2017, 14 months.
Results were first posted in Oct 2019, 2 years 2 months after primary completion.
Of 2,253 non-industry interventional studies with no phase under Obesity, half reached primary completion within 26 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 50. This study's 14 months is below that.
Counting every sponsor, half of 2,351 studies reached it within 26 months; a quarter within 11 and three quarters within 48.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Oct 2017. You cannot join it, but the record below documents what was studied.
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