Fructose: Substrate, Stimulus, or Both?

NCT04168372 | Active Not Recruiting

• 1 other identifier: M-3018
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

Brief Summary

This objective of this study is to use sensitive methodology under controlled conditions to investigate the mechanisms by which fructose consumption contributes to excess fatty acid synthesis and elevations in blood glucose levels following consumption of meals containing fructose.

Conditions

Pre Diabetes; Insulin Resistance; Insulin Sensitivity

Keywords

Fructose; Glucose; Lipogenesis

Outcome Measures

Primary Outcomes (3)

• Hepatic fractional de novo lipogenesis in triglyceride rich lipoprotein (TRL)

  Measured by the detection of 13C carbons in TRL-palmitate from administered 13C labeled pyruvate or 13C labeled fructose.

  6 hours

• Rate of appearance of UDP-glucose

  An estimate of hepatic glycogen flux measured by administration of D1 galactose and acetaminophen

  6 hours

• Rate of appearance of blood glucose from gluconeogenesis

  Measured by the dilution method of labeled glucose

  6 hours

Secondary Outcomes (9)

• Serum triglyceride concentration

  6 hours

• Serum glucose concentration

  6 hours

• Serum lactate concentration

  6 hours

• Serum insulin concentration

  6 hours

• Serum free fatty acid concentration

  6 hours

Study Arms (4)

High fructose meal, with fructose label

EXPERIMENTAL

2-13C fructose incorporated into a meal with high fructose content

Other: High fructose, fructose labeled meal

High fructose meal, with pyruvate label

EXPERIMENTAL

2-13C pyruvate incorporated into a meal with high fructose content

Other: High fructose, pyruvate labeled meal

Low fructose meal, with fructose label

EXPERIMENTAL

2-13C fructose incorporated into a meal with low fructose content

Other: Low fructose, fructose labeled meal

Low fructose meal, with pyruvate label

EXPERIMENTAL

2-13C pyruvate incorporated into a meal with low fructose content

Other: Low fructose, pyruvate labeled meal

Interventions

High fructose, fructose labeled meal OTHER

Liquid meal containing high fructose (16% of energy), labeled with 2-13C fructose

High fructose meal, with fructose label

High fructose, pyruvate labeled meal OTHER

Liquid meal containing high fructose (16% of energy), labeled with 2-13C pyruvate

High fructose meal, with pyruvate label

Low fructose, fructose labeled meal OTHER

Liquid meals containing low fructose (6% of energy), labeled with 2-13C fructose

Low fructose meal, with fructose label

Low fructose, pyruvate labeled meal OTHER

Liquid meal containing low fructose (6% of energy), labeled with 2-13C pyruvate

Low fructose meal, with pyruvate label

Eligibility Criteria

• Age: 20 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Body Mass Index 22 to 35 kg/m2
• Prediabetic (HbA1c 5.7% to 6.5%) or hyperinsulinemic (fasting insulin ≥12 µIU/mL) but non-diabetic (fasting glucose \<126mg/dL and HbA1c \< 6.5%) ; or normal control (fasting insulin \<10 µIU/mL, fasting glucose \<100 mg/dL, and HbA1c \< 5.7%)

You may not qualify if:

• Pregnancy or lactation within the past six months
• Type 1 or 2 diabetes mellitus
• History of liver disease or aspartate aminotransferase (AST) and alanine aminotransferase (ALT) 2x the upper limit of normal (ULN);
• Fasting triglyceride or total cholesterol levels above 95th percentile for age and sex;
• Hemoglobin or hematocrit below the lower limit of normal for sex;
• Report of hepatitis or HIV infection;
• History of cancer, use of any anti-diabetic medications or hypolipidemic agents in the past six months;
• History of surgical procedure for obesity;
• Self-reported change in body weight \>5% in the past six months;
• History of other conditions known to affect insulin sensitivity and lipid metabolism;
• Known intolerance to acetaminophen or components of the liquid test meals.

Sponsors & Collaborators

• Touro University, California: lead

Study Sites (1)

Touro University California

Vallejo, California, 94592, United States

Location

MeSH Terms

Conditions

Insulin Resistance; Glucose Intolerance

Condition Hierarchy (Ancestors)

Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Hyperglycemia

Study Officials

• Jean-Marc Schwarz, PhD

  Touro University, California

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 14, 2019
• First Posted: November 19, 2019
• Study Start: September 15, 2019
• Primary Completion (Estimated): May 31, 2026
• Study Completion (Estimated): December 20, 2026
• Last Updated: April 24, 2026

Record last verified: 2025-04

Locations

US (1)