NCT06878781 Postprandial Metabolome and Metabolic Flexibility
| NCT ID | NCT06878781 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Instituto Nacional de Medicina Genomica |
| Condition | Fasting |
| Study Type | INTERVENTIONAL |
| Enrollment | 300 participants |
| Start Date | 2024-01-08 |
| Primary Completion | 2026-01-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 300 participants in total. It began in 2024-01-08 with a primary completion date of 2026-01-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
Inclusion Criteria: * 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 Criteria: * 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
Contact & Investigator
Berenice Palacios-Gonzalez, PhD
PRINCIPAL INVESTIGATOR
National Institute of Genomic Medicine
Frequently Asked Questions
Who can join the NCT06878781 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 30 Years, studying Fasting. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06878781 currently recruiting?
Yes, NCT06878781 is actively recruiting participants. Contact the research team at bpalacios@inmegen.gob.mx for enrollment information.
Where is the NCT06878781 trial being conducted?
This trial is being conducted at Mexico City, Mexico.
Who is sponsoring the NCT06878781 clinical trial?
NCT06878781 is sponsored by Instituto Nacional de Medicina Genomica. The principal investigator is Berenice Palacios-Gonzalez, PhD at National Institute of Genomic Medicine. The trial plans to enroll 300 participants.