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New treatment option for Nutrition Intake
Official title A Randomized, Triple-blind, Placebo-controlled Study to Evaluate the Effects of a Supplement on Nutrient Gaps and Gut Health Among Individuals Utilizing GLP-1 RAs
ClinicalTrials.gov ID: NCT07437911
What this study is testing
- What it's testing
- This study is a triple-blind, placebo-controlled, randomized controlled trial of 120 adults that will evaluate the impact of a novel nutritional supplement on improving nutrient gaps and changing nutrient status and the gut microbiome among glucagon-like peptide-1 receptor agonist (GLP-1 RA) users.
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 59
You may be able to join if
- Be male or female
- Be aged 18-59.
- Has a BMI between 20-31.9.
- Anyone currently taking GLP-1 medication at their maintenance dose (week 8+), and without any plans to alter their dosage. This includes: Semaglutide...
- Anyone willing to follow the study protocol, including immediately prior to the all blood tests, duplicating their diet for 72 hours (3 days)...
You likely can't join if
- Anyone with a diagnosis of Type I or Type II diabetes.
- Anyone with a diagnosis of any metabolic health condition, such as hypertension and dyslipidemia.
- Anyone who has taken any multivitamin/multimineral supplements within the past 3 months.
- Anyone who has taken a probiotic supplement within the past month.
- Anyone who has regularly consumed (5 days/week or more) products that target healthy aging, anti-aging, longevity, gut health, energy, or ingestive...
- Anyone who has received an antibiotic, antifungal, antiparasitic, or antiviral treatment within the past 90 days.
See the full eligibility criteria
- Be male or female
- Be aged 18-59.
- Has a BMI between 20-31.9.
- Anyone currently taking GLP-1 medication at their maintenance dose (week 8+), and without any plans to alter their dosage. This includes: Semaglutide (Ozempic®, Wegovy®, Rybelsus®), Liraglutide (Saxenda®, Victoza®)...
- Anyone willing to follow the study protocol, including immediately prior to the all blood tests, duplicating their diet for 72 hours (3 days), refraining from caffeine and exercise for 24 hours, and fasting for 10 hours.
- Anyone willing to maintain their current diet, sleep pattern, and activity levels for the duration of the trial.
- Anyone willing to avoid introducing any other supplements, medications, or herbal remedies for the duration of this trial.
- Anyone who is generally healthy - does not live with any diagnosed uncontrolled chronic disease.
- Has access to a consistent weighing scale for the duration of the study.
- Resides in the United States.
- Anyone with a diagnosis of Type I or Type II diabetes.
- Anyone with a diagnosis of any metabolic health condition, such as hypertension and dyslipidemia.
- Anyone who has taken any multivitamin/multimineral supplements within the past 3 months.
- Anyone who has taken a probiotic supplement within the past month.
- Anyone who has regularly consumed (5 days/week or more) products that target healthy aging, anti-aging, longevity, gut health, energy, or ingestive behaviour (such as cravings), including resveratrol, quercetin...
- Anyone who has received an antibiotic, antifungal, antiparasitic, or antiviral treatment within the past 90 days.
- Anyone who has a known history of severe digestive disorders or metabolic conditions that impact nutrient absorption or metabolism, including acid reflux, Irritable Bowel Syndrome (IBS), Irritable Bowel Disease (IBD)...
- Anyone with any known allergies or hypersensitivities to any supplement product ingredients.
- Anyone with any chronic health conditions that could impact participation in this study, such as asthma, gout, fibromyalgia, chronic inflammatory conditions (such as Crohn's, Lupus, HIV/AIDS), thyroid conditions, cancer...
- Anyone currently pregnant, trying to conceive, or breastfeeding.
- Anyone who has undergone a change in hormone therapy (including oral contraceptives) within the past 4 weeks, or is unwilling to maintain their current hormone therapy/oral contraceptive use throughout the course of the...
- Anyone who consumes more than 2 standard alcoholic drinks per day or more than 10 drinks per week, or has within the past 6 months.
- Anyone who is currently a smoker or has been a smoker within the past month.
- Anyone who follows a specific exclusion diet, including vegan, vegetarian, carnivore, paleo, atkins, or ketogenic.
The study team makes the final eligibility decision.
Where it's taking place
- Santa Monica, California, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 59 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Santa Monica, California, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.