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

Diabetes Mellitus, Type 2 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05129735
• Other study ID #: 20227Teatis
• Status: Not yet recruiting
• Phase: N/A
• Start date: September 15, 2022
• Est. completion date: December 30, 2022

Study information

• Verified date: April 2022
• Source: Teatis, Inc
• Contact: Patrick Renner, MSc
• Phone: 4242450284
• Email: hello[@]citruslabs.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: December 30, 2022
• Est. primary completion date: December 30, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2

Intervention

Dietary Supplement:
• Meal 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.

Locations

Country	Name	City	State
United States	Citruslabs	Santa Monica	California

Sponsors (2)

Lead Sponsor	Collaborator
Teatis, Inc	Citruslabs

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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