Study to Determine the Effect of Synbiotics in Patients With Pre-diabetes (Rheostat)
|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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT04428606|
Recruitment Status : Recruiting
First Posted : June 11, 2020
Last Update Posted : April 19, 2021
|Condition or disease||Intervention/treatment||Phase|
|PreDiabetes||Dietary Supplement: Metabolic Rheostat Dietary Supplement: Butyrate Ultra Dietary Supplement: Placebo||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||60 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||This is a double blinded, pilot placebo-controlled trial of two interventions compared to placebo to determine the effects individually of Metabolic Rheostat™ and Butyrate Ultra daily consumption for 8 weeks on glucose homeostasis in subjects with prediabetes. The study will include 20 subjects with prediabetes treated with Metabolic Rheostat™; 20 subjects with prediabetes treated with Butyrate Ultra and 20 subjects with prediabetes treated with placebo. Participants will take 6 capsules daily, two capsules three times per day 30 minutes prior to each meal for 56 days.|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|Official Title:||Placebo Controlled Pilot Trial to Determine the Effect of Metabolic Rheostat™ and Butyrate Ultra on Hemoglobin A1C and Blood Glucose Levels in Patients With Pre-diabetes|
|Actual Study Start Date :||April 1, 2021|
|Estimated Primary Completion Date :||March 30, 2022|
|Estimated Study Completion Date :||December 20, 2022|
Experimental: Metabolic Rheostat™
Participants will take 6 capsules of Rheostat daily, two capsules three times per day 30 minutes prior to each meal for 56 days.
Dietary Supplement: Metabolic Rheostat
Metabolic Rheostat™ Ingredients: Ginseng extract, Ginseng root extract, berberine chloride, Livaux (gold kiwi powder), MegaSporeBiotic, and MenaquinGold (vitamin K2-7) powder
Experimental: Butyrate Ultra
Participants will take 6 capsules Butyrate Ultra daily, two capsules three times per day 30 minutes prior to each meal for 56 days.
Dietary Supplement: Butyrate Ultra
An anerobic probiotic supplement that contains butyrate-producing Butyricicoccus pullicaecorum 25-3T, vitamin K2, and fenugreek to maintain healthy glucose balance.
Placebo Comparator: Placebo
Participants will take 6 capsules of placebo daily, two capsules three times per day 30 minutes prior to each meal for 56 days.
Dietary Supplement: Placebo
- Blood glucose effects of dietary supplement: Metabolic Rheostat vs. Butyrate Ultra [ Time Frame: 2 hours ]Determine the effect of Metabolic Rheostat™ and Butyrate Ultra on blood glucose levels after a liquid meal challenge in patients with pre-diabetes.
- Metabolic impact of Metabolic Rheostat and Butyrate Ultra [ Time Frame: 8 weeks ]Determining the effects of Metabolic Rheostat™ and Butyrate Ultra on gut hormones/incretins (including insulin, C-peptide, glucagon, CCK, GLP-1, GIP, and PYY) using Luminex bead-based technology.
- Impact of Metabolic Rheostat and Butyrate Ultra on food addiction and cravings [ Time Frame: 8 weeks ]Exploratory of Food Addiction (FA) using the Yale Food Addiction Scale (0 symptoms to 11 symptoms). Scale indications are: mild = 2-3 symptoms plus impairment or distress, moderate = 4-5 symptoms plus impairment or distress, severe = 6 or more symptoms plus impairment or distress).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04428606
|Contact: Gail Thames||310-825-0453||Gthames@mednet.ucla.edu|
|Contact: Jeraldine Guzmanfirstname.lastname@example.org|
|United States, California|
|UCLA Center for Human Nutrition, 1000 Veteran Ave.||Recruiting|
|Los Angeles, California, United States, 90095|
|Contact: Gail Thames 310-825-0453 email@example.com|
|Contact: Jeraldine Guzman 310-206-8292 firstname.lastname@example.org|
|Principal Investigator: Zhaoping Li|