Metabolic Effects of Fructose Intake

Not Applicable

Recruiting

• Conditions: Healthy

• Registration Number: NCT06671756
• Lead Sponsor: Baylor College of Medicine

Brief Summary

The goal of this clinical trial is to learn how fructose ingestion affects metabolic factors in healthy adults aged 18-64, with a BMI between 19 and 30 kg/m², of any sex or gender. Specifically, the study aims to examine the impact of fructose compared to glucose on circulating metabolic factors including the soluble leptin receptor.

The main questions it aims to answer are:

How does fructose ingestion influence levels of circulating metabolic markers, including the soluble leptin receptor? Does fructose consumption have different metabolic effects compared to glucose?

Participants will:

Complete a screening phone call to review their health history and eligibility.

Attend two in-person visits at least two weeks apart, where they will:

Fast for 8 hours beforehand. Consume a beverage containing either 75g of fructose or glucose. Have blood drawn at regular intervals for up to 5 hours after consumption to measure circulating levels of metabolic markers.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-10-24
• Study First Submitted QC: 2024-10-31
• Study First Posted: 2024-11-04
• Status Verified: 2024-12
• Study Start: 2024-12-02
• Last Update Submitted: 2024-12-03
• Last Update Posted: 2024-12-05
• Primary Completion: 2025-04-30
• Study Completion: 2025-05-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

• Age: Participants must be between 18 and 64 years old.
• BMI: Participants must have a Body Mass Index (BMI) between 19 and 30 kg/m² (healthy weight to slightly overweight).
• Health Status: Participants must be healthy volunteers with no significant medical conditions.
• Sex/Gender: Both males and females are eligible to participate.

Exclusion Criteria

• Known significant medical illness, any medications except oral contraceptives, history of fructose intolerance, pregnancy. We will not enroll BCM Medical students or individuals who work directly for any of the study investigators.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
Changes in Circulating Levels of Soluble Leptin Receptor After Fructose Ingestion	From baseline (Day 0) to 300 minutes post-ingestion.	The study will measure changes in the blood levels of soluble leptin receptor (ng/mL) following fructose ingestion. These levels will be assessed at multiple time points-baseline (0 minutes), 30 minutes, 60 minutes, 120 minutes, 180 minutes, 240 minutes, and 300 minutes post-ingestion-to evaluate how fructose affects their concentrations compared to baseline levels and glucose ingestion.

Secondary Outcome Measures

Name	Time	Method
Change in Circulating Levels of fibroblast growth factor 21(FGF 21)	From baseline (0 minutes) to 300 minutes post-ingestion.	The study will assess changes in FGF21 levels (pg/mL) in response to fructose and glucose ingestion. FGF21 levels will be measured at specific time points-baseline (0 minutes), 30 minutes, 60 minutes, 120 minutes, 180 minutes, 240 minutes, and 300 minutes post-ingestion-to explore the effects of these sugars.
Change in Circulating Insulin Levels	From baseline (0 minutes) to 300 minutes post-ingestion.	The study will evaluate changes in insulin levels (µIU/mL) following fructose and glucose ingestion. Insulin levels will be measured at baseline (0 minutes), 30 minutes, 60 minutes, 120 minutes, 180 minutes, 240 minutes, and 300 minutes post-ingestion to assess how these sugars affect insulin secretion and metabolic regulation.
Change in Triglyceride Levels	From baseline (0 minutes) to 300 minutes post-ingestion.	The study will measure changes in circulating triglyceride levels (mg/dL) to explore how fructose and glucose ingestion affect lipid metabolism. Triglyceride levels will be measured at baseline (0 minutes), 30 minutes, 60 minutes, 120 minutes, 180 minutes, 240 minutes, and 300 minutes post-ingestion.
Change in Cholesterol Levels	From baseline (0 minutes) to 300 minutes post-ingestion.	The study will assess changes in total cholesterol levels ((mg/dL) following fructose and glucose ingestion to evaluate potential effects on cholesterol metabolism. Cholesterol levels will be measured at baseline (0 minutes), 30 minutes, 60 minutes, 120 minutes, 180 minutes, 240 minutes, and 300 minutes post-ingestion.

Trial Locations

Locations (1)

Baylor St. Luke's Medical Center; 🇺🇸 Houston, Texas, United States