RecruitingNot ApplicableNCT06878781

Postprandial Metabolome and Metabolic Flexibility

Standardized Meals With Different Macronutrient Ratios on the Postprandial Metabolome and Metabolic Flexibility


Sponsor

Instituto Nacional de Medicina Genomica

Enrollment

300 participants

Start Date

Jan 8, 2024

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 YearsMax Age: 30 Years

Inclusion Criteria4

  • 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.

Exclusion Criteria8

  • 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

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Interventions

OTHERHigh carbohydrate challenge

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.

OTHERHigh lipid challenge

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.

OTHERHigh proteinchallenge

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.


Locations(1)

Berenice Palacios-Gonzalez

Mexico City, Mexico

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NCT06878781


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