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OpenTrials
Completed

NCT Number: NCT06671756

Metabolic Effects of Fructose Intake

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.

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Key information

Conditions

Healthy

Age range

18 year–64 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Baylor St. Luke's Medical Center

Houston, Texas, 77030, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Fructose Ingestion

Dietary Supplement

Participants will consume a beverage containing 75g of fructose dissolved in 225ml of water.

Glucose Ingestion

Dietary Supplement

Participants will consume a beverage containing 75g of glucose dissolved in 225ml of water.

Primary outcomes

  1. Changes in Circulating Levels of Soluble Leptin Receptor After Fructose Ingestion

    Time frame: 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 outcomes

  1. Change in Circulating Levels of fibroblast growth factor 21(FGF 21)

    Time frame: 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.

  2. Change in Circulating Insulin Levels

    Time frame: 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.

  3. Change in Triglyceride Levels

    Time frame: 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.

  4. Change in Cholesterol Levels

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Baylor College of Medicine

Other

Registry information

Official study title

The Metabolic Response to Fructose Ingestion

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Nov 4, 2024
Registry last updated
Jul 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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