Study to Assess Safety and Effect of a Prebiotic Fiber Meal Replacement Shake in Individuals With Type 2 Diabetes

Diabetes Mellitus, Type 2 Clinical Trial

Official title:

A Double-Blind, Randomized, Placebo-Controlled Study to Assess the Safety and Effect on Quality of Life of a Prebiotic Fiber Meal Replacement Shake in Individuals With Type 2 Diabetes

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05110703
• Other study ID #: 001-001
• Status: Completed
• Phase: N/A
• Start date: October 11, 2021
• Est. completion date: March 1, 2022

Study information

• Verified date: July 2022
• Source: Uplifting Results Labs Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study is a double-blind, randomized, trial of a commercially available meal-replacement shake versus a placebo control designed to evaluate the impact on quality of life, safety, and tolerability. It also includes a randomized, non-blinded third arm consisting of only dietary guidelines.

Description:

A total of 147 participants will be recruited for the study following screening, with the expectation that approximately 131 participants will complete the trial. The 147 participants will be randomized to the three different study arms in a 2:1:1 ratio with the commercially available meal-replacement shake group being the one favored, i.e., 73 participants in that arm and 37 in the other two arms.

The trial will be mostly virtual, with in-person visits to a laboratory facility for blood draws, as well as standardized BMI calculations, waist circumference, and blood pressure readings. A technology platform will be utilized to screen, enroll and capture study data of the participants.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 192
• Est. completion date: March 1, 2022
• Est. primary completion date: March 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• Diagnosed with T2D for =90 days

• HbA1c of 7.5 to 10.5%, inclusive

• BMI of 27 to 50 kg/m2, inclusive

• Treatment for T2D with lifestyle intervention only (for at least 90 days) or, if using antidiabetic medication(s), treated with a stable daily dose (for at least 90 days) of any of the following agents alone or in any combination: metformin (any formulation), sulfonylurea (e.g., glyburide, glipizide, glimepiride), DPP-4 inhibitor (e.g., sitagliptin, saxagliptin, linagliptin), SGLT-2 inhibitor (e.g., empagliflozin, canagliflozin, dapagliflozin, ertugliflozin), GLP-1 receptor agonists (e.g., liraglutide, semaglutide, dulaglutide)

Exclusion Criteria:

• Have type 1 diabetes or secondary forms of diabetes (e.g., secondary to cystic fibrosis)

• Have a history of severe hypoglycemia or hyperglycemia requiring hospitalization within the prior 6 months

• Have required insulin therapy for the treatment of T2D (with the exception of prior acute, temporary use during a hospitalization and/or for past treatment of gestational diabetes)

• Treatment with any glucose-lowering agent(s) other than those stated in the inclusion criteria during a period of 90 days prior to screening

• Receiving chronic oral steroid therapy (excluding those for skin, eyes, nose, or inhaled) or have received such therapy within 1 month of screening

• Female who is pregnant, breastfeeding or intends to become pregnant during the course of the study

• Participation in a clinical research trial within 30 days prior to screening

• Food allergies to ingredients in the shake including but not limited to milk protein allergy

• Ankylosing spondylitis

• Crohn's disease

• Celiac disease

• Cardiovascular (CV) conditions within 2 months prior to screening: acute myocardial infarction, cerebrovascular accident (stroke), or hospitalization due to congestive heart failure (CHF)

• Other gastrointestinal conditions which in the investigator's opinion may jeopardize the individual's safety or interfere with the ability to comply with the study.

• Gastrointestinal surgeries such as those for weight loss, large bowel resection or small bowel resection which in the investigator's opinion may jeopardize the individual's safety or interfere with the ability to comply with the study.

• Have a history of any other condition such as known drug, alcohol abuse, or psychiatric disorder which in the investigator's opinion may jeopardize the individual's safety or interfere with the ability to comply with the study.

• Any disorder, unwillingness or inability, which in the investigator's opinion, might jeopardize the individual's safety or interfere with the ability to comply with the study.

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2

Intervention

Dietary Supplement:
• Supergut
Meal replacement shake
• Placebo
Placebo

Other:
• Dietary guidelines
Dietary guidelines

Locations

Country	Name	City	State
United States	Citruslabs	Santa Monica	California

Sponsors (1)

Lead Sponsor	Collaborator
Uplifting Results Labs Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Examination of the effect of daily use of a prebiotic fiber meal replacement (PFMR) shake on quality of life [Time Frame: Baseline to 12 weeks]	The endpoint will be reported by the participant on a scale to measure the quality of life. Participants will complete the surveys at baseline and 12-weeks. The study uses a questionnaire including a scale from 0-5 to assess their quality of life(0=not a problem and 5=a very serious problem).	12 weeks
Secondary	To examine the effect of PFMR shakes on hunger [Time Frame: Baseline to 12 weeks]	The endpoints will be reported by the participant as follows: Hunger: surveys at baseline and 12-weeks. The study uses a questionnaire including a scale from 0-10 to assess hunger (0=starving & beyond and 10=thanksgiving full)	12 weeks
Secondary	Changes from baseline on gastrointestinal symptoms after daily use of PFMR shakes [Time Frame: Baseline to 12 weeks]	The endpoints will be reported by the participant as follows: Gastrointestinal symptoms: surveys at baseline and 12-weeks. The study uses a questionnaire including a scale from 0-7 to assess gastrointestinal discomfort (0=no discomfort at all and 7=very severe discomfort)	12 weeks
Secondary	Changes from baseline in fruit, vegetable, and fiber consumption. [Time Frame: Baseline to 12 weeks]	The endpoints will be reported by the participant as follows: Fruit, vegetable, and fiber consumption: surveys at baseline and 12-weeks. The study uses a questionnaire including a scale from 0-6 to assess consumption (0=no consumption; 6=daily consumption)	12 weeks
Secondary	Changes from baseline in A1C associated with type 2 diabetes (T2D) after daily use of PFMR shakes [Time Frame: Baseline to 12 weeks]	Changes in biomarkers associated with T2D (changes in a1c) at baseline, 4-weeks, and 12-weeks.	12 weeks
Secondary	Changes from baseline in blood pressure after daily use of PFMR shakes on blood pressure. [Time Frame: Baseline to 12 weeks]	Changes in blood pressure at baseline, 4-weeks, and 12-weeks.	12 weeks
Secondary	Changes from baseline in body weight after daily use of PFMR shakes. [Time Frame: Baseline to 12 weeks]	Changes in body weight (in lbs) are measured at baseline, 4-weeks, and 12-weeks.	12 weeks
Secondary	Changes from baseline on short-chain fatty acid synthesis from baseline after daily use of PFMR shakes. [Time Frame: Baseline to 12 weeks]	Changes is short chain fatty acids synthesis measured with an at-home stool kit at baseline, 4 weeks, and 12 weeks.	12 weeks