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NCT06329544 · ClinicalTrials.gov registry record · NA
High Fructose Diet, the Gut Microbiome, and Metabolic Health
A NA study of Obesity and Type 2 Diabetes, sponsored by Icahn School of Medicine at Mount Sinai.
- Recruiting
- Registry status
- NA
- Development phase
- 30
- Enrollment target
- 1
- Study location
NCT06329544 is a NA study of Obesity and Type 2 Diabetes that is actively recruiting participants, run by Icahn School of Medicine at Mount Sinai. The registered enrollment target is 30 participants, below the 819-participant average among 1,053 other Obesity trials with a reported enrollment target (96% lower). The trial reports 1 study location across 1 state.
The verdict
NCT06329544, a NA study of Obesity and Type 2 Diabetes, is actively recruiting participants, sponsored by Icahn School of Medicine at Mount Sinai.
- RECRUITING
- Registry status
- NA
- Development phase
- 30 participants
- Enrollment target
- 1
- Study location
Study Summary
Americans commonly consume excess amounts of dietary fructose. Added fructose has been shown to have an adverse impact on metabolic health, including increased insulin resistance and type 2 diabetes (T2D) risk. However, the mechanisms that link dietary fructose and metabolic health are poorly understood. Malabsorption or incomplete metabolism of fructose in the small intestine is common in the population. Excess fructose reaches the colon where it may change the structure and function of the gut microbiome, alter bacterial metabolites and trigger inflammatory responses impacting T2D risk. To elucidate whether commonly consumed levels of dietary fructose influence metabolic outcomes through altering the gut microbiome, the research team will randomize 30 participants to a controlled cross-over dietary intervention, in which the participants will consume 12-day isocaloric, added fructose or glucose diets (25% of total calories) separated by a 10-day controlled diet washout period. The research team aims to: 1. Determine the relationships between high fructose consumption, the gut microbiome and metabolic risk. 2. Characterize the causal role(s) that fructose-induced alterations to the gut microbiome have on metabolic risk using a germ-free mouse model. The research team will measure 1) microbiota community structure and function via metagenomic sequencing of stool, 2) fecal metabolites via targeted and untargeted metabolomics, 3) anthropometrics, 4) insulin resistance, serum markers of T2D risk and inflammatory cytokines, 5) fecal microbial carbohydrate oxidation capacity and 6) liver fat via MRI elastography. The research team will use novel statistical approaches, including Distributed Lag Modeling, to understand the complex relationships between diet, the microbiome, metabolites and health outcomes. The research team will then conduct controlled dietary interventions and fecal microbiome transplantation studies in germ-free mice. Donor fecal samples from human
Conditions Studied
Interventions
- DIETARY_SUPPLEMENT Fructose
- DIETARY_SUPPLEMENT glucose
Study Locations (1)
New York
- Mount Sinai Morningside - New York
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2024-10-08 |
| Est. Completion | 2028-08-31 |
| Phase | NA |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06329544
The ClinicalTrials.gov registry entry for NCT06329544 describes a study currently listed as recruiting, categorized as NA. The registered enrollment target is 30 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 819-participant average among 1,053 other Obesity trials with a reported enrollment target (96% lower). The listed sponsor is Icahn School of Medicine at Mount Sinai, which has 708 total studies on file at ClinicalTrials.gov.
The record links to 3 conditions, with Obesity appearing as the primary indexed condition, and to 2 interventions - of which Fructose is the first listed.
NCT06329544 reports 1 study location spanning 1 distinct geographic area - top geographies include New York.
Frequently Asked Questions
What is clinical trial NCT06329544 about?
NCT06329544 is a clinical study titled "High Fructose Diet, the Gut Microbiome, and Metabolic Health". Americans commonly consume excess amounts of dietary fructose. Added fructose has been shown to have an adverse impact on metabolic health, including increased insulin resistance and type 2 diabetes (T2D) risk. However, the mechanisms that link dietary fructose and metabolic health are poorly unders...
What is the current status of trial NCT06329544?
This trial is currently recruiting. It is a NA study. The enrollment target is 30 participants. The study started on 2024-10-08. Estimated completion is 2028-08-31.
What conditions does trial NCT06329544 study?
This clinical trial studies the following conditions: Obesity, Type 2 Diabetes, MASLD.
What interventions are being tested in trial NCT06329544?
The interventions under investigation include: Fructose (DIETARY_SUPPLEMENT), glucose (DIETARY_SUPPLEMENT).
Who is sponsoring clinical trial NCT06329544?
This trial is sponsored by Icahn School of Medicine at Mount Sinai, which has 708 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06329544 being conducted?
This trial has 1 study location across New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Related
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