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History of Changes for Study: NCT05110703
Study to Assess Safety and Effect of a Prebiotic Fiber Meal Replacement Shake in Individuals With Type 2 Diabetes
Latest version (submitted July 7, 2022) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 October 26, 2021 None (earliest Version on record)
2 February 10, 2022 IPDSharing, Eligibility, Study Design, Study Description, Sponsor/Collaborators and Study Status
3 July 7, 2022 Recruitment Status, Study Status, Contacts/Locations, Arms and Interventions and Study Design
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Study NCT05110703
Submitted Date:  October 26, 2021 (v1)

Open or close this module Study Identification
Unique Protocol ID: 001-001
Brief Title: Study to Assess Safety and Effect of a Prebiotic Fiber Meal Replacement Shake in Individuals With Type 2 Diabetes
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
Secondary IDs:
Open or close this module Study Status
Record Verification: October 2021
Overall Status: Recruiting
Study Start: October 11, 2021
Primary Completion: March 1, 2022 [Anticipated]
Study Completion: March 1, 2022 [Anticipated]
First Submitted: October 4, 2021
First Submitted that
Met QC Criteria:
October 26, 2021
First Posted: November 8, 2021 [Actual]
Last Update Submitted that
Met QC Criteria:
October 26, 2021
Last Update Posted: November 8, 2021 [Actual]
Open or close this module Sponsor/Collaborators
Sponsor: Uplifting Results Labs Inc.
Responsible Party: Sponsor
Collaborators: Citruslabs
Open or close this module Oversight
U.S. FDA-regulated Drug: No
U.S. FDA-regulated Device: No
Data Monitoring: No
Open or close this module 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.
Detailed Description:

A total of 219 participants will be recruited for the study following screening, with the expectation that approximately 200 participants will complete the trial. The 219 participants will be randomized to the three different study arms, 73 participants per arm.

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.

Open or close this module Conditions
Conditions: Diabetes Mellitus, Type 2
Keywords: Diabetes
Microbiome
Fiber
Prebiotic
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Other
Study Phase: Not Applicable
Interventional Study Model: Parallel Assignment
This will be a 3-arm randomized, double-blinded (for the two meal replacement arms), placebo-controlled study
Number of Arms: 3
Masking: Triple (Participant, Care Provider, Investigator)
Allocation: Randomized
Enrollment: 219 [Anticipated]
Open or close this module Arms and Interventions
Arms Assigned Interventions
Active Comparator: Dietary supplement: Prebiotic fiber meal replacement shake
Prebiotic fiber meal replacement shake
Dietary Supplement: Muniq
Meal replacement shake
Placebo Comparator: Dietary supplement: Placebo meal replacement shake
Placebo meal replacement shake
Dietary Supplement: Placebo
Placebo
Dietary guidelines
Dietary guidelines
Dietary guidelines
Dietary guidelines
Open or close this module 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.
Open or close this module Eligibility
Minimum Age: 18 Years
Maximum Age: 75 Years
Sex: All
Gender Based:
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 40 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.
Open or close this module Contacts/Locations
Central Contact Person: Patrick Renner, MSc
Telephone: 4242450284
Email: hello@citruslabs.com
Study Officials: Juan Frias, MD
Principal Investigator
Uplifting Results Labs Inc.
Locations: United States, California
Citruslabs
[Recruiting]
Santa Monica, California, United States, 90404
Contact:Contact: Patrick Renner, MSc 424-245-0284 hello@citruslabs.com
Open or close this module IPDSharing
Plan to Share IPD: Undecided
Undecided
Open or close this module References
Citations:
Links:
Available IPD/Information:

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U.S. National Library of Medicine | U.S. National Institutes of Health | U.S. Department of Health & Human Services