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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Diabetes Mellitus, Type 2
• Intervention / Treatment: Dietary supplement: Meal replacement shake

• Study Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Patrick Renner, MSc; Phone Number: 4242450284; Email: hello@citruslabs.com

Study Locations

• United States
  • California
    • Santa Monica, California, United States, 90404
      • Citruslabs
      • Contact: Patrick Renner, MSc; Phone Number: 424-245-0284; Email: hello@citruslabs.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Meal replacement shake; Teatis meal replacement shake	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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Teatis, Inc
• Collaborators: Citruslabs

Study record dates

Study Major Dates

• Study Start (Anticipated): September 15, 2022
• Primary Completion (Anticipated): December 30, 2022
• Study Completion (Anticipated): December 30, 2022

Study Registration Dates

• First Submitted: November 3, 2021
• First Submitted That Met QC Criteria: November 18, 2021
• First Posted (Actual): November 22, 2021

Study Record Updates

• Last Update Posted (Actual): April 27, 2022
• Last Update Submitted That Met QC Criteria: April 25, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2
• Other Study ID Numbers: 20227Teatis

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No