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

NCT05110703 | Completed

• 1 other identifier: 001-001
• Study Type: interventional
• Target: 192
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetes Mellitus, Type 2

Keywords

Diabetes; Microbiome; Fiber; Prebiotic

Outcome Measures

Primary Outcomes (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]

  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 Outcomes (7)

• To examine the effect of PFMR shakes on hunger [Time Frame: Baseline to 12 weeks]

  12 weeks

• Changes from baseline on gastrointestinal symptoms after daily use of PFMR shakes [Time Frame: Baseline to 12 weeks]

  12 weeks

• Changes from baseline in fruit, vegetable, and fiber consumption. [Time Frame: Baseline to 12 weeks]

  12 weeks

• Changes from baseline in A1C associated with type 2 diabetes (T2D) after daily use of PFMR shakes [Time Frame: Baseline to 12 weeks]

  12 weeks

• Changes from baseline in blood pressure after daily use of PFMR shakes on blood pressure. [Time Frame: Baseline to 12 weeks]

  12 weeks

Study Arms (3)

Dietary supplement: Prebiotic fiber meal replacement shake

ACTIVE COMPARATOR

Prebiotic fiber meal replacement shake

Dietary Supplement: Supergut

Dietary supplement: Placebo meal replacement shake

PLACEBO COMPARATOR

Placebo meal replacement shake

Dietary Supplement: Placebo

Dietary guidelines

OTHER

Dietary guidelines

Other: Dietary guidelines

Interventions

Supergut DIETARY_SUPPLEMENT

Meal replacement shake

Dietary supplement: Prebiotic fiber meal replacement shake

Placebo DIETARY_SUPPLEMENT

Placebo

Dietary supplement: Placebo meal replacement shake

Dietary guidelines OTHER

Dietary guidelines

Dietary guidelines

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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)
• 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.

Sponsors & Collaborators

• Uplifting Results Labs Inc.: lead

Study Sites (1)

Citruslabs

Santa Monica, California, 90404, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Diabetes Mellitus

Interventions

Nutrition Policy

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Health Policy; Public Policy; Social Control Policies; Policy; Health Care Economics and Organizations

Study Officials

• Juan Frias, MD

  Uplifting Results Labs Inc.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: This will be a 3-arm randomized, double-blinded (for the two meal replacement arms), placebo-controlled study

Study Record Dates

• First Submitted: October 4, 2021
• First Posted: November 8, 2021
• Study Start: October 11, 2021
• Primary Completion: March 1, 2022
• Study Completion: March 1, 2022
• Last Updated: July 11, 2022

Record last verified: 2022-07

Locations

US (1)