Observational Metabolic Health Study

NCT06790407 | Completed

• 1 other identifier: PS10
• Study Type: observational
• Target: 96
• Locations: 1 country
• Sites: 1

Brief Summary

The rationale for this study is to observe the effect of a consumer-grade commercially available product called Mimio Biomimetic Cell Care on metabolic health in overweight individuals. Additionally, the study aims to observe the effects of the study product on hunger and satiety, as well as effects on cognitive function, sleep, stress, pain, mood, gastrointestinal symptoms and metabolic and inflammatory blood markers via activities that can successfully and effectively be completed in a home setting. Because this product is currently available in the OTC market across the United States, a consumer-driven, decentralized observational clinical research study is well-suited for examining the effects of this study product in this population. The study will examine outcomes in a broad age range of adults who have chosen to try this product. The study will incorporate participant reported outcome questionnaires and surveys, blood sample collection for NMR lipoprofile, oxidized LDL, hsCRP, HbA1c, Insulin and plasma glucose and a saliva sample collection for biological age test. There is no "doctor-patient" relationship as part of this research since the participant as a consumer is making the informed choice to take the product and take part in the observational process with self-reported measures, saliva sample collection and blood sample collection at their local laboratory. Findings from this study will contribute knowledge toward the design of future studies and important knowledge on metabolic health.

Conditions

Healthy

Keywords

Healthy Population

Outcome Measures

Primary Outcomes (1)

• Determine the effect of the study product on hunger and satiety

  The primary objective of this study is to determine the effect of the study product on hunger and satiety via a 7-item Hunger, Satiety and Cravings scale. The higher the score, the worse the outcome. The study team aggregates individual changes in the survey from the baseline period to week 8 and compares placebo and product groups using non-parametric statistics or parametric statistics, depending on final data distribution. Univariate statistics will be generated to describe the distribution of patient characteristics and outcome data. Continuous variables will be described using means, medians, standard deviations/median absolute deviations, minimums and maximums while categorical variables will be described using counts and percentages. The study team is testing the null hypothesis that there is no difference between placebo group and study product groups on mean or ranked scores within study participants.

  Participants will complete up to a 14-week study consisting of a screening period, randomization and shipping period, a 2-week baseline period, and an 8-week product/placebo use period.

Secondary Outcomes (7)

• Assess the effect of the study product on cognitive function

  Participants will complete up to a 14-week study consisting of a screening period, randomization and shipping period, a 2-week baseline period, and an 8-week product/placebo use period.

• Assess the effect of the study product on cognitive and behavioral eating

  Participants will complete up to a 14-week study consisting of a screening period, randomization and shipping period, a 2-week baseline period, and an 8-week product/placebo use period.

• Assess the effect of the study product on metabolic blood markers

  Participants will complete up to a 14-week study consisting of a screening period, randomization and shipping period, a 2-week baseline period, and an 8-week product/placebo use period.

• Observe the effect of the study product on epigenetic profile/biological age

  Participants will complete up to a 14-week study consisting of a screening period, randomization and shipping period, a 2-week baseline period, and an 8-week product/placebo use period.

• Assess the effect of the study product on gastrointestinal symptoms

  Participants will complete up to a 14-week study consisting of a screening period, randomization and shipping period, a 2-week baseline period, and an 8-week product/placebo use period.

Study Arms (2)

Mimio Product Group

Participants are randomized to the Mimio Study Product Group or the Placebo.

Dietary Supplement: Mimio Study Product

Placebo Group

Participants are randomized to the Mimio Study Product Group or the Placebo.

Dietary Supplement: Placebo

Interventions

Mimio Study Product DIETARY_SUPPLEMENT

Active ingredients in the Mimio study product include Nicotinamide 250mg, Ultra-Micronized Palmitoylethanolamide 600mg, Oleoylethanolamide 400mg, Spermidine 8mg; Other Ingredients: Hydroxypropyl-Methylcellulose (capsule), Silicon Dioxide, Magnesium Stearate.

Mimio Product Group

Placebo DIETARY_SUPPLEMENT

Non-active study ingredients in the placebo include Micro Crystalline Cellulose 250mg, Hypromellose, Titanium Dioxide.

Placebo Group

Eligibility Criteria

• Age: 55 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Healthy participants who meet the eligibility criteria will be recruited through People Science community, email outreach, advocacy groups and social media channels. Advertisements will be in paper and digital format and will link to a study landing page to enable sign up.

You may qualify if:

• Age 55 years old and above
• Have a BMI between 25 to 29.9 from self-reported weight and height measured within the last 6 months prior to randomization
• Interested in understanding more about their metabolic health
• If taking any prescription medication for cholesterol (e.g. statins) or other class of medications for metabolic disorders such as metformin, ACE inhibitors, beta blockers, rapamycin, thiazolidinediones, etc., must be on a stable dose for at least 4 weeks prior to randomization and throughout the course of the study
• If taking any fiber supplements, must be on a stable dose for at least 4 weeks prior to randomization and throughout the course of the study. If not on a stable dose, must be willing to stop at least 1 week prior to randomization and throughout the course of the study.
• If taking any other supplement products such as fish oil, resveratrol, alpha-ketoglutarate, berberine, ashwagandha, pre- and probiotics, melatonin, NAD+ precursors (niacin, nicotinamide riboside (NR), nicotinamide mononucleotide (NMN), NADH, etc), fisetin, astaxanthin, urolithin-A, CoQ-10, green tea extract or EGG, pterostilbene, must be willing to stop at least 1 week prior to randomization and throughout the course of the study
• If using any cannabis, THC, or CBD containing products regularly, must be willing to stop at least 1 week prior to randomization and throughout the course of the study
• Must be on a consistent and regular diet for at least 2 months prior to randomization and willing to maintain it throughout the course of the study
• For females, must be in menopausal stage
• In good general health at the time of screening (Investigator discretion).
• Able to read and understand English.
• Able to read, understand, and provide informed consent.
• Able to use a personal smartphone device and download Chloe by People Science.
• Able to receive shipment of the product at an address within the United States.
• Able and willing to travel to a local Quest Diagnostics laboratory for blood sample collection (with fasting) twice during the course of the study

You may not qualify if:

• Do not have a personal smartphone, internet access, or unwilling to download Chloe.
• Concomitant Therapies:
• GLP-1 receptor agonists and related incretin mimetics, (e.g. semaglutide (Ozempic, Rybelsus), dulaglutide (Trulicity), exenatide (Byetta, Bydureon), liraglutide (Victoza, Saxenda), lixisenatide (Adlyxin), sitagliptin (Januvia, Janumet), saxagliptin (Onglyza, Komblglyze), alogliptin (Nesina, Kazano, Oseni), linagliptin (Tradjenta, Jentadueto) or tirzepatide (Mounjaro))
• Hormone Replacement Therapy (especially fluctuating/ cycle mimicking dose) or Hormonal Contraceptives (oral or IUD)
• Participants receiving any investigational therapies or treatments within 30 days prior to randomization.
• Concurrent participation in any other investigational study during the study period.
• Regular use of over-the-counter allergy or pain medications (including ibuprofen, acetaminophen, aspirin, naproxen, diphenhydramine, cetirizine, loratadine, fexofenadine ) (\>3-4 times/week).
• Other Illnesses or Conditions: Participants who have the following comorbidities or conditions are excluded:
• Currently or previously diagnosed with Obesity (BMI greater than 29.9)
• Known diagnosis of Type 1 or Type 2 Diabetes Mellitus requiring medical intervention.
• Known diagnosis of an eating disorder
• Currently diagnosed with Alcohol Abuse and/or Substance Use Disorder
• Women not yet in menopause (Have had a menstrual period within the last 12 months)
• Currently diagnosed with Anemia
• Significant cardiovascular disease or severe cardiac event, except hypertension.

Sponsors & Collaborators

• Mimio Health, Inc.: lead
• People Science, Inc.: collaborator

Study Sites (1)

People Science, Inc.

Los Angeles, California, 90034, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Blood sample collection for NMR lipoprofile, oxidized LDL, hsCRP, HbA1c, Insulin and plasma glucose

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 4, 2024
• First Posted: January 24, 2025
• Study Start: August 26, 2024
• Primary Completion: December 27, 2024
• Study Completion: January 31, 2025
• Last Updated: May 11, 2025

Record last verified: 2024-12

Locations

US (1)