Acute Inflammatory and Metabolic Effect of High Fructose Intake

NCT05573438 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 22

Last updated 2022-10-10

No results posted yet for this study

Summary

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).

Conditions

  • Inflammatory Response
  • Metabolic Disturbance

Interventions

OTHER

Group fructose

Participants will receive a standardized meal of bread, ham, and margarine plus a sweetened drink (200mL) with fructose. 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 (24) plus 10% referring to the thermal effect of food. The meal will have 15% of protein, 30% of fat, and 55% of carbohydrate (30% of complex carbohydrates and 25% of fructose. The sweetened drinks will have artificial fruit flavor to avoid the identification of the content by the researchers and the volunteers.

OTHER

Group Sucrose

Participants will receive a standardized meal of bread, ham, and margarine plus a sweetened drink (200mL) with sucrose. 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 (24) plus 10% referring to the thermal effect of food. The meal will have 15% of protein, 30% of fat, and 55% of carbohydrate (30% of complex carbohydrates and 25% of sucrose. The sweetened drinks will have artificial fruit flavor to avoid the identification of the content by the researchers and the volunteers.

OTHER

Group Glucose

Participants will receive a standardized meal of bread, ham, and margarine plus a sweetened drink (200mL) with glucose. 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 (24) plus 10% referring to the thermal effect of food. The meal will have 15% of protein, 30% of fat, and 55% of carbohydrate (30% of complex carbohydrates and 25% of glucose. The sweetened drinks will have artificial fruit flavor to avoid the identification of the content by the researchers and the volunteers.

Sponsors & Collaborators

  • Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.

    collaborator OTHER_GOV
  • Fundação de Amparo à Pesquisa do estado de Minas Gerais

    collaborator OTHER
  • Conselho Nacional de Desenvolvimento Científico e Tecnológico

    collaborator OTHER_GOV
  • Adaliene Versiani M. Ferreira

    lead OTHER

Principal Investigators

  • Adaliene VM Ferreira, PhD · Federal University of Minas Gerais

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
CROSSOVER

Eligibility

Min Age
20 Years
Max Age
50 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2015-01-01
Primary Completion
2017-11-30
Completion
2017-11-30

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05573438 on ClinicalTrials.gov