Postprandial Metabolome and Metabolic Flexibility

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-30
SponsorInstituto Nacional de Medicina Genomica

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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;

give written consent for their inclusion in the study.

Disqualifiers

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.

subjects who only have samples (blood and calorimetry) from one study period (fasting or postprandial);

Trial design

Design model

Crossover

Treatments tested in this trial

  • High carbohydrate challenge

    Other intervention

    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 lipid challenge

    Other intervention

    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 proteinchallenge

    Other intervention

    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.

Treatment groups

300 Participants
are divided into 3 treatment groups
Group A: High carbohydrate challengeExperimental treatment 1 intervention
Group B: High lipid challengeExperimental treatment 1 intervention
Group C: High protein challengeExperimental treatment 1 intervention

Trial outcomes

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.

Time frame
Once a week for three weeks

Secondary outcomes

1

Postprandial Glucose Levels

Measure of postprandial glucose concentration (ml/dL) after meal intake.

Time frame
Once a week for three weeks
2

Postprandial Triglyceride Levels

Measure of postprandial triglyceride concentration (mg/dL) after meal intake.

Time frame
Once a week for three weeks
3

Postprandial Acyl Carnitines Levels

Measure of postprandial acyl carnitines concentration (µmol/L) after meal intake.

Time frame
Once a week for three weeks
4

Postprandial Amino Acid Levels

Measure of postprandial amino acid concentration (µmol/L) after meal intake.

Time frame
Once a week for three weeks

Other outcomes

Sponsors and contacts

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Instituto Nacional de Medicina Genomica

Lead sponsor

Universidad Nacional Autonoma de Mexico

Collaborator