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

NCT ID: NCT05129735

Last Updated: 2024-08-23

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-09-15
• Study Completion Date: 2022-12-30

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.

Conditions

Diabetes Mellitus, Type 2

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Meal replacement shake

Teatis meal replacement shake

Group Type: EXPERIMENTAL

Meal replacement shake

Intervention Type: DIETARY_SUPPLEMENT

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.

Interventions

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.

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Citruslabs

INDUSTRY

Sponsor Role: collaborator

Teatis, Inc

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Susanne Mitschke, MSc

Role: PRINCIPAL_INVESTIGATOR

Citruslabs

Locations

Citruslabs

Santa Monica, California, United States

Countries

United States

Other Identifiers

20227Teatis

Identifier Type: -

Identifier Source: org_study_id