Clinical trial NCT06671756: Metabolic Effects of Fructose Intake
Official title: The Metabolic Response to Fructose Ingestion
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Healthy
Keywords: Fructose
Metabolism
Soluble Leptin Receptor
Lead sponsor: Baylor College of Medicine
Sponsor class: OTHER
First posted: 2024-11-04
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Changes in Circulating Levels of Soluble Leptin Receptor After Fructose Ingestion
timeFrame: From baseline (Day 0) to 300 minutes post-ingestion.
Secondary outcomes:
measure: Change in Circulating Levels of fibroblast growth factor 21(FGF 21)
timeFrame: From baseline (0 minutes) to 300 minutes post-ingestion.
measure: Change in Circulating Insulin Levels
timeFrame: From baseline (0 minutes) to 300 minutes post-ingestion.
measure: Change in Triglyceride Levels
timeFrame: From baseline (0 minutes) to 300 minutes post-ingestion.
measure: Change in Cholesterol Levels
timeFrame: From baseline (0 minutes) to 300 minutes post-ingestion.
Other outcomes:
Locations:
city: Houston
country: United States
facility: Baylor St. Luke's Medical Center
state: Texas
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.