Metabolic Effects of Fructose Intake

NCT06671756 | Completed

• 1 other identifier: H55353
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy

Keywords

Fructose; Metabolism; Soluble Leptin Receptor

Outcome Measures

Primary Outcomes (1)

• Changes in Circulating Levels of Soluble Leptin Receptor After Fructose 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.

  From baseline (Day 0) to 300 minutes post-ingestion.

Secondary Outcomes (4)

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

  From baseline (0 minutes) to 300 minutes post-ingestion.

• Change in Circulating Insulin Levels

  From baseline (0 minutes) to 300 minutes post-ingestion.

• Change in Triglyceride Levels

  From baseline (0 minutes) to 300 minutes post-ingestion.

• Change in Cholesterol Levels

  From baseline (0 minutes) to 300 minutes post-ingestion.

Study Arms (2)

Fructose First, Glucose Second (10 participants)

EXPERIMENTAL

Participants will first consume 75g of fructose in 225ml of water. Blood samples will be taken at specific intervals to measure metabolic responses. After 2 weeks, they will consume 75g of glucose in 225ml of water, with blood samples taken at the same intervals.

Dietary Supplement: Fructose Ingestion; Dietary Supplement: Glucose Ingestion

Glucose First, Fructose Second (10 participants)

EXPERIMENTAL

Participants will first consume 75g of glucose in 225ml of water, followed by the same blood sampling schedule. After 2 weeks, they will switch to 75g of fructose, with blood samples taken at the same intervals.

Dietary Supplement: Fructose Ingestion; Dietary Supplement: Glucose Ingestion

Interventions

Fructose Ingestion DIETARY_SUPPLEMENT

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

Fructose First, Glucose Second (10 participants); Glucose First, Fructose Second (10 participants)

Glucose Ingestion DIETARY_SUPPLEMENT

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

Fructose First, Glucose Second (10 participants); Glucose First, Fructose Second (10 participants)

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Baylor College of Medicine: lead

Study Sites (1)

Baylor St. Luke's Medical Center

Houston, Texas, 77030, United States

Location

Related Publications (5)

• Fisher FM, Kim M, Doridot L, Cunniff JC, Parker TS, Levine DM, Hellerstein MK, Hudgins LC, Maratos-Flier E, Herman MA. A critical role for ChREBP-mediated FGF21 secretion in hepatic fructose metabolism. Mol Metab. 2016 Nov 23;6(1):14-21. doi: 10.1016/j.molmet.2016.11.008. eCollection 2017 Jan.

  PMID: 28123933 BACKGROUND

• Katz LS, Baumel-Alterzon S, Scott DK, Herman MA. Adaptive and maladaptive roles for ChREBP in the liver and pancreatic islets. J Biol Chem. 2021 Jan-Jun;296:100623. doi: 10.1016/j.jbc.2021.100623. Epub 2021 Apr 2.

  PMID: 33812993 BACKGROUND

• Kim MS, Krawczyk SA, Doridot L, Fowler AJ, Wang JX, Trauger SA, Noh HL, Kang HJ, Meissen JK, Blatnik M, Kim JK, Lai M, Herman MA. ChREBP regulates fructose-induced glucose production independently of insulin signaling. J Clin Invest. 2016 Nov 1;126(11):4372-4386. doi: 10.1172/JCI81993. Epub 2016 Sep 26.

  PMID: 27669460 BACKGROUND

• Sargsyan A, Doridot L, Hannou SA, Tong W, Srinivasan H, Ivison R, Monn R, Kou HH, Haldeman JM, Arlotto M, White PJ, Grimsrud PA, Astapova I, Tsai LT, Herman MA. HGFAC is a ChREBP-regulated hepatokine that enhances glucose and lipid homeostasis. JCI Insight. 2023 Jan 10;8(1):e153740. doi: 10.1172/jci.insight.153740.

  PMID: 36413406 BACKGROUND

• Herman MA, Birnbaum MJ. Molecular aspects of fructose metabolism and metabolic disease. Cell Metab. 2021 Dec 7;33(12):2329-2354. doi: 10.1016/j.cmet.2021.09.010. Epub 2021 Oct 6.

  PMID: 34619074 BACKGROUND

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor; Chief, Section of Endocrinology, Diabetes, and Metabolism, Medicine, Baylor College of Medicine

Study Record Dates

• First Submitted: October 24, 2024
• First Posted: November 4, 2024
• Study Start: December 2, 2024
• Primary Completion: April 30, 2025
• Study Completion: May 31, 2025
• Last Updated: July 24, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF, CSR, ANALYTIC CODE
• Time Frame: This information will be available for 5 years following publication of the study.
• Access Criteria: Academic investigators upon request to the study's PI.

Locations

US (1)