NCT05573438

Acute Inflammatory and Metabolic Effect of High Fructose Intake

Completed NA Last updated 10 October 2022

What this trial tests

NA trial testing Group fructose in Inflammatory Response in 22 participants. Completed in 30 November 2017.

Timeline

1 January 2015

Primary endpoint
30 November 2017

30 November 2017

Quick facts

Lead sponsor	Adaliene Versiani M. Ferreira
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	crossover
Masking	triple
Primary purpose	prevention
Enrollment	22
Start date	1 January 2015
Primary completion	30 November 2017
Estimated completion	30 November 2017

Drugs / interventions tested

• Group fructose
• Group Sucrose
• Group Glucose

Conditions studied

• Inflammatory Response — all drugs for Inflammatory Response →
• Metabolic Disturbance — all drugs for Metabolic Disturbance →

Sponsor

Adaliene Versiani M. Ferreira

Who can join

Adults 20 to 50, female only, with Inflammatory Response or Metabolic Disturbance. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Fructose consumption is associated with the development of metabolic diseases and low-grade inflammation. However, the acute effect of a single meal rich in fructose on the metabolic and inflammatory response is not fully understood. This study will to evaluate the acute metabolic and inflammatory effect caused by a meal containing fructose overload. This will be a three-arm crossover, randomized, double-blind clinical trial.

Participants will undergo the three interventions for random order: (i) standardized meal plus sucrose overload; (ii) standardized meal plus glucose overload; (iii) standardized meal plus fructose overload. During the washout period (7 to 21 days), the subjects will instructed to maintain their usual eating behavior and physical activity.

On the day of each intervention, participants will to the outpatient clinic in the morning after an overnight fast. Anthropometric data (weight, height, and waist circumference) will collected. Body composition will evaluated using bioimpedance (Quantum® apparatus, RJM Systems, Michigan) and blood pressure and heart rate (digital monitor, model HEM705CP®, Omron) will measured after 30 minutes of rest.

A catheter with a three-way stopcock will inserted into the arm of the volunteers. Blood samples (5mL) will collected after overnight fasting (baseline) and 30, 60, 120, and 240 minutes after the standardized meal containing sucrose or glucose or fructose overload. Participants will remain seated throughout the evaluation period. Participants will receive a standardized meal of bread, ham, and margarine plus a sweetened drink (200mL) with similar amounts of different carbohydrates (sucrose, glucose, or fructose) in each intervention. The meals will provide 25% of the energy requirements, calculated from the resting energy expenditure measured by indirect calorimetry (KORR®, MetaCheck) multiplied by the activity factor plus 10% referring to the thermal effect of food. The meal will consiste of 15% of protein, 30% of fat, and 55% of carbohydrate (30% of complex carbohydrates and 25% of sucrose or glucose or fructose).

Serum levels of glucose, triglycerides, total cholesterol, alanine aminotransferase (ALT) and aspartate aminotransferase (AST) will be measured by colorimetric enzymatic test. Serum levels of adiponectin, leptin, resistin and TNF will be measured by Enzyme Linked ImmuneSorbent Assay (ELISA). Serum levels of IL-2, IL-4, IL-5, IL-6, IL-10, IL-17, IFN-γ and eotaxin will be obtained by the Cytometric Bead Array (CBA).

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.