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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05110703
Recruitment Status : Completed
First Posted : November 8, 2021
Last Update Posted : July 11, 2022
Sponsor:
Information provided by (Responsible Party):
Uplifting Results Labs Inc.

Tracking Information
First Submitted Date  ICMJE October 4, 2021
First Posted Date  ICMJE November 8, 2021
Last Update Posted Date July 11, 2022
Actual Study Start Date  ICMJE October 11, 2021
Actual Primary Completion Date March 1, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 26, 2021)
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).
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 26, 2021)
  • 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)
  • 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)
  • 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)
  • 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.
  • 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.
  • 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.
  • 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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study to Assess Safety and Effect of a Prebiotic Fiber Meal Replacement Shake in Individuals With Type 2 Diabetes
Official Title  ICMJE 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
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.
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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE 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
Condition  ICMJE Diabetes Mellitus, Type 2
Intervention  ICMJE
  • Dietary Supplement: Supergut
    Meal replacement shake
  • Dietary Supplement: Placebo
    Placebo
  • Other: Dietary guidelines
    Dietary guidelines
Study Arms  ICMJE
  • Active Comparator: Dietary supplement: Prebiotic fiber meal replacement shake
    Prebiotic fiber meal replacement shake
    Intervention: Dietary Supplement: Supergut
  • Placebo Comparator: Dietary supplement: Placebo meal replacement shake
    Placebo meal replacement shake
    Intervention: Dietary Supplement: Placebo
  • Dietary guidelines
    Dietary guidelines
    Intervention: Other: Dietary guidelines
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 7, 2022)
192
Original Estimated Enrollment  ICMJE
 (submitted: October 26, 2021)
219
Actual Study Completion Date  ICMJE March 1, 2022
Actual Primary Completion Date March 1, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT05110703
Other Study ID Numbers  ICMJE 001-001
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Current Responsible Party Uplifting Results Labs Inc.
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Uplifting Results Labs Inc.
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Juan Frias, MD Uplifting Results Labs Inc.
PRS Account Uplifting Results Labs Inc.
Verification Date July 2022

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP