An interventional study of Supergut and Placebo in Diabetes Mellitus, Type 2, sponsored by Uplifting Results Labs Inc.. Completed at 1 site in United States. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2022-07-11.
Sponsored by Uplifting Results Labs Inc. · Not applicable, Interventional, and Other
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.
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.
9,590 studies on the registry are indexed under Diabetes Mellitus, Type 2; 1,332 are open to participants now.
This study's enrollment of 192 is above the median of 81 across 7,713 interventional studies indexed under Diabetes Mellitus, Type 2.
Browse Diabetes Mellitus, Type 2 studies →This is the only study on the registry with Uplifting Results Labs Inc. as lead sponsor.
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Exclusion Criteria:
Prebiotic fiber meal replacement shake
Dietary Supplement: Supergut
Placebo meal replacement shake
Dietary Supplement: Placebo
Dietary guidelines
Other: Dietary guidelines
Meal replacement shake
Placebo
Dietary guidelines
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).
Time frame: 12 weeks
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)
Time frame: 12 weeks
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)
Time frame: 12 weeks
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)
Time frame: 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]
Changes in biomarkers associated with T2D (changes in a1c) at baseline, 4-weeks, and 12-weeks.
Time frame: 12 weeks
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.
Time frame: 12 weeks
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.
Time frame: 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]
Changes is short chain fatty acids synthesis measured with an at-home stool kit at baseline, 4 weeks, and 12 weeks.
Time frame: 12 weeks
Plan to share: Undecided
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This study is completed, as verified in Jul 2022. You cannot join it, but the record below documents what was studied.
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