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

• ClinicalTrials.gov Identifier: NCT05110703
• Recruitment Status: Completed
• First Posted: November 8, 2021
• Last Update Posted: July 11, 2022
• Sponsor: Uplifting Results Labs Inc.
• Information provided by (Responsible Party): Uplifting Results Labs Inc.

Study Description

Brief 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.

Condition or disease	Intervention/treatment	Phase
Diabetes Mellitus, Type 2	Dietary Supplement: Supergut; Dietary Supplement: Placebo; Other: Dietary guidelines	Not Applicable

Detailed 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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 192 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: This will be a 3-arm randomized, double-blinded (for the two meal replacement arms), placebo-controlled study
• Masking: Triple (Participant, Care Provider, Investigator)
• Primary Purpose: Other
• 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
• Actual Study Start Date: October 11, 2021
• Actual Primary Completion Date: March 1, 2022
• Actual Study Completion Date: March 1, 2022

Arms and Interventions

Arm	Intervention/treatment
Active Comparator: Dietary supplement: Prebiotic fiber meal replacement shake; Prebiotic fiber meal replacement shake	Dietary Supplement: Supergut; Meal replacement shake
Placebo Comparator: Dietary supplement: Placebo meal replacement shake; Placebo meal replacement shake	Dietary Supplement: Placebo; Placebo
Dietary guidelines; Dietary guidelines	Other: Dietary guidelines; Dietary guidelines

Outcome Measures

Primary Outcome Measures :

1. 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] [ Time Frame: 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).

Secondary Outcome Measures :

1. To examine the effect of PFMR shakes on hunger [Time Frame: Baseline to 12 weeks] [ Time Frame: 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)
2. Changes from baseline on gastrointestinal symptoms after daily use of PFMR shakes [Time Frame: Baseline to 12 weeks] [ Time Frame: 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)
3. Changes from baseline in fruit, vegetable, and fiber consumption. [Time Frame: Baseline to 12 weeks] [ Time Frame: 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)
4. Changes from baseline in A1C associated with type 2 diabetes (T2D) after daily use of PFMR shakes [Time Frame: Baseline to 12 weeks] [ Time Frame: 12 weeks ]
   Changes in biomarkers associated with T2D (changes in a1c) at baseline, 4-weeks, and 12-weeks.
5. Changes from baseline in blood pressure after daily use of PFMR shakes on blood pressure. [Time Frame: Baseline to 12 weeks] [ Time Frame: 12 weeks ]
   Changes in blood pressure at baseline, 4-weeks, and 12-weeks.
6. Changes from baseline in body weight after daily use of PFMR shakes. [Time Frame: Baseline to 12 weeks] [ Time Frame: 12 weeks ]
   Changes in body weight (in lbs) are measured at baseline, 4-weeks, and 12-weeks.
7. Changes from baseline on short-chain fatty acid synthesis from baseline after daily use of PFMR shakes. [Time Frame: Baseline to 12 weeks] [ Time Frame: 12 weeks ]
   Changes is short chain fatty acids synthesis measured with an at-home stool kit at baseline, 4 weeks, and 12 weeks.

Eligibility Criteria

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

Criteria

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.

Contacts and Locations

Locations

United States, California

Citruslabs

Santa Monica, California, United States, 90404

Sponsors and Collaborators

Uplifting Results Labs Inc.

Investigators

• Principal Investigator: Juan Frias, MD; Uplifting Results Labs Inc.

More Information

• Responsible Party: Uplifting Results Labs Inc.
• ClinicalTrials.gov Identifier: NCT05110703
• Other Study ID Numbers: 001-001
• First Posted: November 8, 2021
• Last Update Posted: July 11, 2022
• Last Verified: July 2022

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Undecided

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Uplifting Results Labs Inc.:

Diabetes; Microbiome; Fiber; Prebiotic

Additional relevant MeSH terms:

Diabetes Mellitus; Diabetes Mellitus, Type 2; Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases