Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| People Science | UNKNOWN |
Not provided
Not provided
Not provided
Not provided
The main objective of this study is to evaluate the chronic effects of replacing traditional non-diet soda with a prebiotic soda on biomarkers associated with glycemic control in adults with glucose dysregulation who are habitual consumers of traditional soda.
The primary aim of this clinical trial is to evaluate the effects of replacing traditional non-diet soda with a prebiotic soda (i.e., OLIPOP) over an 8 week period on markers of glucose (blood sugar) control in adults with glucose (blood sugar) dysregulation.
Participants (n=224) will be habitual consumers of traditional non-diet sodas, consuming on average 2-3 servings of non-diet soda daily. Participants will be randomized to either an active control group (continued habitual traditional non-diet soda intake, 2 - 3 servings/day) or a behavioral intervention group (OLIPOP prebiotic soda, 2 cans/day (24 fl. oz/day), 6 g dietary fiber and 2 - 5 g total sugar per 12 fl. oz can).
Secondary outcomes will include evaluating the effects of prebiotic soda consumption on additional markers of metabolic health, including long-term glycemic control and insulin sensitivity.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention | Experimental | Participants will be randomized to replace traditional non-diet soda with prebiotic soda |
|
| Control Group | Active Comparator | Participants will be randomized to continue consumption of traditional non-diet soda. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Prebiotic Soda | Behavioral | Participants will replace traditional non-diet sodas in their diet with a prebiotic soda (OLIPOP). Participants will consume 2 cans/day (24 fl. oz/day) that will add 12 g dietary fiber/day to their diet. |
| Measure | Description | Time Frame |
|---|---|---|
| Effects on Fasting Plasma Glucose | Change in fasting plasma glucose | Baseline to 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Effects on Long-term Glycemic Control | Change in HbA1c | Baseline to week 8 |
| Effect on insulin sensitivity | Change in fasting plasma insulin |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Megha Doshi | Contact | megha@peoplescience.health | ||
| People Science | Contact | ps48metabolichealthstudy@peoplescience.health |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| People Science | Recruiting | Los Angeles | California | 90045 | United States |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Randomized, Open-Label, Controlled
Not provided
Not provided
Not provided
Not provided
| Active Control | Behavioral | Participants will continue to consume their habitual intake (on average 2-3 servings/day) of traditional non-diet soda. |
|
| Baseline to week 8 |