Acute Inflammatory and Metabolic Effect of High Fructose Intake

NCT05573438 | Completed

• 1 other identifier: CAAE: 21852314.7.0000.5149
• Study Type: interventional
• Target: 22
• Locations: 0 countries
• Sites: N/A

Brief 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

Keywords

Fructose; Postprandial Period; Inflammation; Metabolism

Outcome Measures

Primary Outcomes (3)

• Changes in serum levels of triglycerides

  Triglycerides (ml/dL)

  Change from Baseline serum level at 240 minutes postprandial.

• Changes in serum levels of adiponectin

  Adiponectin (pg/dL)

  Change from Baseline serum level at 240 minutes postprandial.

• Changes in serum levels of tumor necrosis factor

  Tumor necrosis factor (pg/dL)

  Change from Baseline serum level at 240 minutes postprandial.

Secondary Outcomes (14)

• Changes in serum levels of interleukin-2

  Change from Baseline serum level at 240 minutes postprandial.

• Changes in serum levels of interleukin-4

  Change from Baseline serum level at 240 minutes postprandial.

• Changes in serum levels of interleukin-5

  Change from Baseline serum level at 240 minutes postprandial.

• Changes in serum levels of interleukin-6

  Change from Baseline serum level at 240 minutes postprandial.

• Changes in serum levels of interleukin-10

  Change from Baseline serum level at 240 minutes postprandial.

Study Arms (3)

Fructose

EXPERIMENTAL

Participants received a standardized meal of bread, ham, and margarine plus a sweetened drink (200mL) with fructose. The meals provided 25% of the energy requirements. The meal consisted of 15% of protein, 30% of fat, and 55% of carbohydrate (30% of complex carbohydrates and 25% of fructose).

Other: Group fructose

Sucrose

EXPERIMENTAL

Participants received a standardized meal of bread, ham, and margarine plus a sweetened drink (200mL) with sucrose. The meals provided 25% of the energy requirements. The meal consisted of 15% of protein, 30% of fat, and 55% of carbohydrate (30% of complex carbohydrates and 25% of sucrose).

Other: Group Sucrose

Glucose

PLACEBO COMPARATOR

Participants received a standardized meal of bread, ham, and margarine plus a sweetened drink (200mL) with glucose. The meals provided 25% of the energy requirements. The meal consisted of 15% of protein, 30% of fat, and 55% of carbohydrate (30% of complex carbohydrates and 25% of glucose).

Other: Group Glucose

Interventions

Group fructose OTHER

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.

Fructose

Group Sucrose OTHER

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.

Sucrose

Group Glucose OTHER

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.

Also known as: Placebo Comparator

Glucose

Eligibility Criteria

• Age: 20 Years - 50 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Women aged
• and 47 years
• body mass index (BMI) from 18.50 to 24.99 kg/m²

You may not qualify if:

• chronic diseases, such as DM, chronic renal failure (CRF), cardiovascular or hepatic diseases, acute inflammatory or autoimmune diseases;
• participants with glycemia \> 99 mg/dL;
• triglycerides \> 200 mg/dL;
• prior bariatric surgery for weight loss;
• people who were taking medication for thyroid disorders, dyslipidemia, insulin sensitivity or DM, CRF, cardiovascular and hepatic diseases, inflammation and/or infection, immunosuppressive and weight loss;
• smokers or people who drink more than two doses of alcohol a day (28g of pure alcohol); and (vii) pregnancy or breast-feeding.

Sponsors & Collaborators

• Adaliene Versiani M. Ferreira: lead
• Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.: collaborator
• Fundação de Amparo à Pesquisa do estado de Minas Gerais: collaborator
• Conselho Nacional de Desenvolvimento Científico e Tecnológico: collaborator

Related Publications (1)

• Rodrigues AMDS, Martins LB, Fagundes GBP, Tibaes JRB, Amaral MHA, Vieira ELM, Oliveira MC, Correia MITD, Ferreira AVM. Acute inflammatory and metabolic effect of high fructose intake in normal-weight women: A randomized, double-masked, crossover trial. Nutrition. 2025 Jan;129:112602. doi: 10.1016/j.nut.2024.112602. Epub 2024 Oct 9.

  PMID: 39442382 DERIVED

MeSH Terms

Conditions

Inflammation

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Adaliene VM Ferreira, PhD

  Federal University of Minas Gerais

  PRINCIPAL INVESTIGATOR

Study Design

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

Model Details: This will be a three-arm crossover, randomized, double-blind clinical trial.

Study Record Dates

• First Submitted: September 22, 2022
• First Posted: October 10, 2022
• Study Start: January 1, 2015
• Primary Completion: November 30, 2017
• Study Completion: November 30, 2017
• Last Updated: October 10, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share