An Exploratory Investigation to Assess Changes in Quality of Life for Individuals With Type 2 Diabetes After Taking a Meal-replacement Shake.

Study Overview
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Brief Summary
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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.

Official Title
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An Exploratory Investigation to Assess Changes in Quality of Life for Individuals With Type 2 Diabetes After Taking a Meal-replacement Shake.

Conditions
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Diabetes Mellitus, Type 2

Intervention / Treatment
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* Dietary Supplement: Meal replacement shake


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: This is an open-label single-arm observational trial
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Meal replacement shake<br>Teatis meal replacement shake | Dietary Supplement: Meal replacement shake<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improvement of quality of life score from baseline to 12-weeks | Survey based quality of life measure on a scale from 0-5 (0=lowest possible score, 5=highest possible score) | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improvement in a1c levels from baseline to 12-weeks | Change in a1c biomarkers measured with an at-home blood test after 12 weeks compared to baseline results. | 12 weeks | 
| Improvement in blood glucose from baseline to 12-weeks | Change in blood glucose biomarkers measured with an at-home blood test after 12 weeks compared to baseline results. | 12 weeks | 
| Improvement in insulin levels from baseline to 12-weeks | Change in insulin levels measured with an at-home blood test after 12 weeks compared to baseline results. | 12 weeks | 
| Improvement in total cholesterol levels from baseline to 12-weeks | Change in total cholesterol measured with an at-home blood test after 12 weeks compared to baseline results. | 12 weeks | 
| Improvement in triglyceride levels from baseline to 12-weeks | Change in triglyceride measured with an at-home blood test after 12 weeks compared to baseline results. | 12 weeks | 
| Improvement in HDL cholesterol levels from baseline to 12-weeks | Change in HDL cholesterol measured with an at-home blood test after 12 weeks compared to baseline results. | 12 weeks | 
| Improvement in LDL cholesterol levels from baseline to 12-weeks | Change in LDL cholesterol measured with an at-home blood test after 12 weeks compared to baseline results. | 12 weeks |