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

NCT05129735 | Withdrawn

• 1 other identifier: 20227Teatis
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• Improvement in a1c levels from baseline to 12-weeks

  12 weeks

• Improvement in blood glucose from baseline to 12-weeks

  12 weeks

• Improvement in insulin levels from baseline to 12-weeks

  12 weeks

• Improvement in total cholesterol levels from baseline to 12-weeks

  12 weeks

• Improvement in triglyceride levels from baseline to 12-weeks

  12 weeks

Study Arms (1)

Meal replacement shake

EXPERIMENTAL

Teatis meal replacement shake

Dietary Supplement: Meal replacement shake

Interventions

Meal replacement shake 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.

Meal replacement shake

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Teatis, Inc: lead
• Citruslabs: collaborator

Study Sites (1)

Citruslabs

Santa Monica, California, 90404, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Susanne Mitschke, MSc

  Citruslabs

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: This is an open-label single-arm observational trial

Study Record Dates

• First Submitted: November 3, 2021
• First Posted: November 22, 2021
• Study Start: September 15, 2022
• Primary Completion: December 30, 2022
• Study Completion: December 30, 2022
• Last Updated: August 23, 2024

Record last verified: 2024-08

Locations

US (1)