Postprandial Metabolome and Metabolic Flexibility

NCT06878781 | Recruiting

• 1 other identifier: 467
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

Brief Summary

Metabolic flexibility is a process in which the body can switch energy substrates in different physiological states. This flexibility plays an important role in an individual's health because losing it increases the risk of obesity, metabolic syndrome, insulin resistance, and type 2 diabetes. Considering that humans spend most of their awakening hours in a postprandial (PP) state, an organism's metabolic flexibility (MF) to respond to a standardized meal's consumption would provide information on the individual's metabolic health. The PP response to glucose following an oral glucose tolerance test or consumption of a high-carbohydrate meal is well described; however, few studies assess the FM and PP metabolome using mixed meals with different macronutrients. The investigators address how metabolic flexibility and metabolome change after consuming standardized meals with different macronutrient ratios. Data collection includes clinical and diet information, indirect calorimetry, and capillary blood sampling during fasting and after consumption of standardized meals. Samples are collected weekly for one month. The data will determine the metabolic flexibility and metabolome after consuming standardized meals with different macronutrient ratios.

Conditions

Fasting; Postprandial Hyperglycemia; Lipid Metabolism Disorders; Glucose Metabolism Disorders; Insulin Sensitivity

Keywords

metabolic flexibility; postprandial response; mixed meals

Outcome Measures

Primary Outcomes (1)

• Metabolic Flexibility Assessed by Respiratory Quotient (RQ) and Substrate Oxidation

  Metabolic flexibility will be assessed by measuring the respiratory quotient (RQ) and substrate oxidation during fasting and postprandial states. RQ values are expected to range from 0.70 to 0.80 during fasting and vary during the postprandial period depending on the food consumed: 0.87-1.00 for the high-carbohydrate challenge, 0.70-80 for the high-fat challenge, and 0.81-0.90 for the high-protein challenge. Measurements will be conducted using the Cardio Coach CO2 Vmax Encore 29 System Calorimeter. Oxygen consumption (VO2) and carbon dioxide production (VCO2) values will be used to calculate energy expenditure using Weir's equation: Energy Expenditure = \[3.941(VO2) + 1.11(VCO2)\] × 1440 min/day.

  Once a week for three weeks

Secondary Outcomes (4)

• Postprandial Glucose Levels

  Once a week for three weeks

• Postprandial Triglyceride Levels

  Once a week for three weeks

• Postprandial Acyl Carnitines Levels

  Once a week for three weeks

• Postprandial Amino Acid Levels

  Once a week for three weeks

Study Arms (3)

High carbohydrate challenge

EXPERIMENTAL

High carbohydrate challenge should be consumed within 15 minutes. After 5 minutes of rest, indirect calorimetry will be postprandially, lasting 30 minutes. Capillary blood shall be obtained at the following times: 15-30-45-60-90 and 120 min after ingestion of food.

Other: High carbohydrate challenge

High lipid challenge

EXPERIMENTAL

High lipid challenge should be consumed within 15 minutes. After 5 minutes of rest, indirect calorimetry will be postprandially, lasting 30 minutes. Capillary blood shall be obtained at the following times: 15-30-45-60-90 and 120 min after ingestion of food.

Other: High lipid challenge

High protein challenge

EXPERIMENTAL

High protein challenge should be consumed within 15 minutes. After 5 minutes of rest, indirect calorimetry will be postprandially, lasting 30 minutes. Capillary blood shall be obtained at the following times: 15-30-45-60-90 and 120 min after ingestion of food.

Other: High proteinchallenge

Interventions

High carbohydrate challenge OTHER

Capillary blood samples will be obtained in the morning after an overnight 8-hour fasting; then, an indirect fasting calorimetry will be performed. After the indirect calorimetry, the metabolic and hormonal response to the test meal is performed. The nutritional composition of the standardized meal is shown below. Energy, 479.6 kcal; Carbohydrate, 83.6%; Lipids, 12.4%, and Protein, 4.0% (70 g of hot cake, 100 g of mango, 270 ml of peach nectar, and 40 g of strawberry jam). The food challenge should be consumed within 15 minutes. After 5 minutes of rest, indirect calorimetry will be postprandially, lasting 30 minutes. Capillary blood shall be obtained at the following times: 15-30-45-60-90 and 120 min after ingestion of food.

High carbohydrate challenge

High lipid challenge OTHER

Capillary blood samples will be obtained in the morning after an overnight 8-hour fasting; then, an indirect fasting calorimetry will be performed. After the indirect calorimetry, the metabolic and hormonal response to the test meal is performed. The nutritional composition of the standardized meal is shown below. Energy, 1043.4 kcal; Carbohydrate, 4.9%; Lipids, 86.8%, and Protein, 8.3% (60 g of manchego cheese, 25 g of egg, white, dried, 24 g of bacon, 5 ml of oil, 65 g of cream cheese, 70 g of cream, and 16 g of poblano pepper). The food challenge should be consumed within 15 minutes. After 5 minutes of rest, indirect calorimetry will be postprandially, lasting 30 minutes. Capillary blood shall be obtained at the following times: 15-30-45-60-90 and 120 min after ingestion of food.

High lipid challenge

High proteinchallenge OTHER

Capillary blood samples will be obtained in the morning after an overnight 8-hour fasting; then, an indirect fasting calorimetry will be performed. After the indirect calorimetry, the metabolic and hormonal response to the test meal is performed. The nutritional composition of the standardized meal is shown below. Energy, 441.3 kcal; Carbohydrate, 1.6%; Lipids, 5.1%, and Protein, 93.3% (2 scoop Isopure Zero Carb, 180 g of chicken breast, 20 g of lettuce and 24 g of ham turkey breast). The food challenge should be consumed within 15 minutes. After 5 minutes of rest, indirect calorimetry will be postprandially, lasting 30 minutes. Capillary blood shall be obtained at the following times: 15-30-45-60-90 and 120 min after ingestion of food.

High protein challenge

Eligibility Criteria

• Age: 18 Years - 30 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• be over 18 years of age and under 30 years of age;
• without active drug addictions: smoking, alcoholism, and/or drug addiction;
• in female subjects: regular menstrual cycles;

You may not qualify if:

• subjects with any pathology that requires medication or special treatment, such as type 2 diabetes mellitus, high blood pressure, dyslipidemia, polycystic ovary syn-drome, autoimmune, thyroid, kidney, neurological diseases, and cancer;
• pregnant or lactating women;
• subjects with problems with chewing, salivation, and swallowing.
• Elimination criteria:
• subjects who only have samples (blood and calorimetry) from one study period (fasting or postprandial);
• subjects who only have samples (blood and calorimetry) of a metabolic challenge;
• subjects who have an infection at the scheduled appointment;
• subjects who withdraw their informed consent

Sponsors & Collaborators

• Instituto Nacional de Medicina Genomica: lead
• Universidad Nacional Autonoma de Mexico: collaborator

Study Sites (1)

Berenice Palacios-Gonzalez

Mexico City, 14610, Mexico

RECRUITING

Related Publications (32)

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MeSH Terms

Conditions

Fasting; Hyperglycemia; Lipid Metabolism Disorders; Glucose Metabolism Disorders; Insulin Resistance

Condition Hierarchy (Ancestors)

Feeding Behavior; Behavior; Metabolic Diseases; Nutritional and Metabolic Diseases; Hyperinsulinism

Study Officials

• Berenice Palacios-Gonzalez, PhD

  National Institute of Genomic Medicine

  PRINCIPAL INVESTIGATOR

• Noemi Meraz-Cruz, PhD

  Universidad Nacional Autonoma de Mexico

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Berenice Palacios-Gonzalez, PhD

CONTACT

5553501900; bpalacios@inmegen.gob.mx

Noemi Meraz-Cruz, PhD

CONTACT

5553501900; nmeraz@inmegen.gob.mx

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: There will be a single-blind principal investigator (PI). All results will be coded and will remain closed until the study is completed. The PI will remain blind to the results until the codes are opened at the end of the study.
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD

Model Details: Enrolled subjects are followed every week for one month. At each visit, a questionnaire assesses daily time-activity patterns. Dietary intake is assessed by a food frequency questionnaire and a multi-step 24-hour dietary recall. Subjects will then be randomized to receive the metabolic challenges in a different order. The procedures will be performed before (fasting; 8-10 hours) and after (postprandial) consumption of the metabolic challenges. Capillary blood samples are obtained in the morning after an 8-hour fasting and after test meal consumption. Once the drop of blood is formed, it is placed directly into the CardioCheck Plus® cassette to determine glucose triglyceride, LDL-cholesterol, HDL-cholesterol, and total cholesterol. A second drop of capillary blood shall be placed on a filter paper. Indirect fasting calorimetry is also performed. After the indirect calorimetry, the metabolic and hormonal response to the test meal is performed.

Study Record Dates

• First Submitted: April 8, 2024
• First Posted: March 17, 2025
• Study Start: January 8, 2024
• Primary Completion: January 30, 2026
• Study Completion (Estimated): December 18, 2026
• Last Updated: March 17, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

ME (1)