Diabetes Mellitus, Type 2
Conditions
Brief summary
This is an open-label single-arm observational trial to study the effectiveness of a commercially available meal-replacement shake and its effect on the quality of life in individuals with type 2 diabetes.
Interventions
DIETARY_SUPPLEMENTMeal replacement shake
Each day for the study period (12 weeks), the participants will take one meal-replacement shake per day for breakfast. The breakfast will be replaced by the shake entirely.
Sponsors
Citruslabs
Teatis, Inc
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
This is an open-label single-arm observational trial
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
Yes
Inclusion criteria
* Male or Female between 18-75 years old * Diagnosed with type 2 diabetes for at least 3 months * HbA1c of 7.5 to 10% inclusive * BMI of 27 to 40 kg/m2 * If on any medication, treated with a stable dose for at least 90 days * Must be in good health (don't report any medical conditions asked in the screening questionnaire) * Willing and able to provide written informed consent * Must have a Glucometer at home
Exclusion criteria
* Diagnosis of type 1 diabetes * Have a history of severe hypoglycemia or hyperglycemia requiring hospitalization within the prior 6 months * Use of dietary supplements or meal-replacement shakes targeted at diabetes and unwilling to stop using them for the duration of the study * Allergies to any test product ingredients * Has any of the following medical conditions: * Oncological conditions * Psychiatric disease * Cardiovascular disease: any hospitalization within the past 3 months * Multiple Sclerosis * Gastrointestinal conditions such as Celiac disease, Crohn's disease, etc. * Any other severe chronic disease * History of drug or alcohol abuse * Females who are pregnant, want to become pregnant for the duration of the study, or who are breastfeeding during the course of the study * Participation in a clinical research trial within 30 days prior to screening * Participating in an investigational health product research study * Any disorder, unwillingness, or inability, which in the investigator's opinion, might jeopardize the individual's safety or compliance with the protocol
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Improvement of quality of life score from baseline to 12-weeks | 12 weeks | Survey based quality of life measure on a scale from 0-5 (0=lowest possible score, 5=highest possible score) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Improvement in blood glucose from baseline to 12-weeks | 12 weeks | Change in blood glucose biomarkers measured with an at-home blood test after 12 weeks compared to baseline results. |
| Improvement in insulin levels from baseline to 12-weeks | 12 weeks | Change in insulin levels measured with an at-home blood test after 12 weeks compared to baseline results. |
| Improvement in total cholesterol levels from baseline to 12-weeks | 12 weeks | Change in total cholesterol measured with an at-home blood test after 12 weeks compared to baseline results. |
| Improvement in a1c levels from baseline to 12-weeks | 12 weeks | Change in a1c biomarkers measured with an at-home blood test after 12 weeks compared to baseline results. |
| Improvement in HDL cholesterol levels from baseline to 12-weeks | 12 weeks | Change in HDL cholesterol measured with an at-home blood test after 12 weeks compared to baseline results. |
| Improvement in LDL cholesterol levels from baseline to 12-weeks | 12 weeks | Change in LDL cholesterol measured with an at-home blood test after 12 weeks compared to baseline results. |
| Improvement in triglyceride levels from baseline to 12-weeks | 12 weeks | Change in triglyceride measured with an at-home blood test after 12 weeks compared to baseline results. |
Countries
United States
Outcome results
None listed