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FastingNCT06878781

Postprandial Metabolome and Metabolic Flexibility

A study testing High carbohydrate challenge, High lipid challenge and High proteinchallenge in people with Fasting and Postprandial Hyperglycemia, run by Instituto Nacional de Medicina Genomica at 1 site in Mexico.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 to 30 yearsHealthy volunteers can take part
What is being tested?
High carbohydrate challenge, High lipid challenge and High proteinchallenge
Could I receive a placebo?
No, everyone receives an active treatment
How many people
300 participants
Where
1 siteMexico
Study dates
8 Jan 2024to 18 Dec 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 30 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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.

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Berenice Palacios-Gonzalez, PhD contact

5553501900 ext. 1451

bpalacios@inmegen.gob.mx

Noemi Meraz-Cruz, PhD contact

5553501900 ext. 1200

nmeraz@inmegen.gob.mx

Mexico1 site, 1 recruiting

  • Berenice Palacios-Gonzalez

    Mexico City, 14610

    Berenice Palacios-Gonzalez, PhD, 5553501900 ext. 1451, bpalacios@inmegen.gob.mx

    Noemi Meraz-Cruz, PhD

    Recruiting

Other trials in Mexico

About this study

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

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.

Read the detailed description

Enrolled subjects are followed every week for one month. At each visit, a questionnaire assesses daily time activity patterns relevant to energy expenditure, general health status, including infectious symptoms, and confirmation of basic social and demographic characteristics. Dietary intake is assessed by a food frequency questionnaire and a multi-step 24-hour dietary recall for quantitative analysis. If symptoms of infection are present, participants are treated with ad-hoc broad antibiotics. Anthropometrics are obtained. 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 (40µ) are obtained in the morning after an 8-hour fasting and after test meal consumption. To obtain the capillary blood sample, sterilize the ring finger with alcohol and allow it to dry. Then, puncture the area with a sterile 2 mm long lancet. 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 (S\&S 903) until a circle of filter paper is filled with blood to saturate the paper throughout its thickness. Insulin concentration shall be determined following the protocol for dried blood, which is standardized in the laboratory. Indirect fasting calorimetry is also performed. After the indirect calorimetry, the metabolic and hormonal response to the test meal is performed.

Each 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.

Nutrient composition of standardized meal and meal example.

  • High carbohydrate challenge: 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)
  • High lipid challenge: 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)
  • High protein challenge: 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)

Determination of metabolites in dried blood To determine the concentration of metabolites (amino acids and acyl-carnitines), a circle of 3 mm diameter shall be punched out of the filter paper and placed in a 96-well plate. Add 100 µl of the acyl-carnitine and amino acid standards from the NeoBase PerkinElmer kit. Subsequently, follow the manufacturer's instructions for determining metabolites by liquid chromatography coupled to mass spectrometry (LC-MS).

Determination of the respiratory quotient (RQ) To determine the respiratory quotient (RQ= VmaxCO2/ VmaxO2) and lipid and carbohydrate oxidation examinations, the Cardio Coach CO2 Vmax Encore 29 System calorimeter software (Korr, Inc, UT, USA) will be used according to the instructions of the supplier. Examinations are invariably performed in the morning (8:00-9:00 am) in a thermoneutral environment with controlled pressure, humidity, and temperature, with the patient supine but awake. The investigators examine a maximum of two subjects per day. Oxygen consumption and carbon dioxide production were obtained using a canopy and were monitored continuously for 30 minutes. The initial 10 minutes of the measurement are discarded for the calculation to ensure greater data homogeneity. O2 consumption and CO2 production will be recorded continuously for 30 min. VO2 and VCO2 values will be used in the equation proposed by Weir (Energy Expenditure = [3.941(VO2) + 1.11(VCO2)] x 1440 min/day), considered as the standard method [34]. Additionally, one day before the test, subjects are instructed to fast for 8 hours and not engage in physical activity or consume caffeine the day before the exam. All participants will be asked to eat the same dinner the night before each test. Dinner provides 15% of the daily energy intake; 20 g of protein, 7 g of lipids, and 34 g of carbohydrates)

Being tested
High carbohydrate challenge, High lipid challenge, High proteinchallenge
Keywords
metabolic flexibility, postprandial response, mixed meals
Medical subject headings
Fasting, Hyperglycemia, Lipid Metabolism Disorders, Glucose Metabolism Disorders, Insulin Resistance

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • High carbohydrate challengeOther

    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 challengeOther

    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 proteinchallengeOther

    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.

Study groups in NCT06878781
Study groupRoleWhat they receive
High carbohydrate challengeExperimentalHigh 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.
Receives: Other: High carbohydrate challenge
High lipid challengeExperimentalHigh 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.
Receives: Other: High lipid challenge
High protein challengeExperimentalHigh 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.
Receives: Other: High proteinchallenge

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Once a week for three weeks

Secondary outcomes (4)

  1. Postprandial Glucose Levels

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

    Measured: Once a week for three weeks

  2. Postprandial Triglyceride Levels

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

    Measured: Once a week for three weeks

  3. Postprandial Acyl Carnitines Levels

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

    Measured: Once a week for three weeks

  4. Postprandial Amino Acid Levels

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

    Measured: Once a week for three weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Mar 2025
  2. Study start8 Jan 2024
  3. Primary completion30 Jan 2026 (estimated)
  4. Study completion18 Dec 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Crossover
Model description
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.
Masking
Single blind
Who is masked
Investigator
Enrolment
300 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06878781
Sponsor's protocol ID
467
Status last verified
Mar 2025
First submitted
8 Apr 2024
Last updated
17 Mar 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Schonknecht YB, Crommen S, Stoffel-Wagner B, Coenen M, Fimmers R, Holst JJ, Simon MC, Stehle P, Egert S. Acute Effects of Three Different Meal Patterns on Postprandial Metabolism in Older Individuals with a Risk Phenotype for Cardiometabolic Diseases: A Randomized Controlled Crossover Trial. Mol Nutr Food Res. 2020 May;64(9):e1901035. doi: 10.1002/mnfr.201901035. Epub 2020 Apr 15.

    PubMed 32223057

  • Weinisch P, Fiamoncini J, Schranner D, Raffler J, Skurk T, Rist MJ, Romisch-Margl W, Prehn C, Adamski J, Hauner H, Daniel H, Suhre K, Kastenmuller G. Dynamic patterns of postprandial metabolic responses to three dietary challenges. Front Nutr. 2022 Sep 22;9:933526. doi: 10.3389/fnut.2022.933526. eCollection 2022.

    PubMed 36211489

  • Kelley DE, Mandarino LJ. Fuel selection in human skeletal muscle in insulin resistance: a reexamination. Diabetes. 2000 May;49(5):677-83. doi: 10.2337/diabetes.49.5.677.

    PubMed 10905472

  • Delgadillo-Velazquez JA, Nambo-Venegas R, Patino N, Meraz-Cruz N, Razo-Azamar M, Guevara-Cruz M, Fonseca M, Pale Montero LE, Ibarra-Gonzalez I, Vela-Amieva M, Vadillo-Ortega F, Palacios-Gonzalez B. Metabolic flexibility during normal pregnancy allows appropriate adaptation during gestation independently of BMI. Clin Nutr ESPEN. 2021 Aug;44:254-262. doi: 10.1016/j.clnesp.2021.06.007. Epub 2021 Jun 19.

    PubMed 34330475

  • Gupta RD, Ramachandran R, Venkatesan P, Anoop S, Joseph M, Thomas N. Indirect Calorimetry: From Bench to Bedside. Indian J Endocrinol Metab. 2017 Jul-Aug;21(4):594-599. doi: 10.4103/ijem.IJEM_484_16.

    PubMed 28670546

  • Lepine G, Tremblay-Franco M, Bouder S, Dimina L, Fouillet H, Mariotti F, Polakof S. Investigating the Postprandial Metabolome after Challenge Tests to Assess Metabolic Flexibility and Dysregulations Associated with Cardiometabolic Diseases. Nutrients. 2022 Jan 21;14(3):472. doi: 10.3390/nu14030472.

    PubMed 35276829

  • Muoio DM. Metabolic inflexibility: when mitochondrial indecision leads to metabolic gridlock. Cell. 2014 Dec 4;159(6):1253-62. doi: 10.1016/j.cell.2014.11.034.

    PubMed 25480291

  • Zeevi D, Korem T, Zmora N, Israeli D, Rothschild D, Weinberger A, Ben-Yacov O, Lador D, Avnit-Sagi T, Lotan-Pompan M, Suez J, Mahdi JA, Matot E, Malka G, Kosower N, Rein M, Zilberman-Schapira G, Dohnalova L, Pevsner-Fischer M, Bikovsky R, Halpern Z, Elinav E, Segal E. Personalized Nutrition by Prediction of Glycemic Responses. Cell. 2015 Nov 19;163(5):1079-1094. doi: 10.1016/j.cell.2015.11.001.

    PubMed 26590418

  • Bansal S, Buring JE, Rifai N, Mora S, Sacks FM, Ridker PM. Fasting compared with nonfasting triglycerides and risk of cardiovascular events in women. JAMA. 2007 Jul 18;298(3):309-16. doi: 10.1001/jama.298.3.309.

    PubMed 17635891

  • Nishida T, Tsuji S, Tsujii M, Arimitsu S, Haruna Y, Imano E, Suzuki M, Kanda T, Kawano S, Hiramatsu N, Hayashi N, Hori M. Oral glucose tolerance test predicts prognosis of patients with liver cirrhosis. Am J Gastroenterol. 2006 Jan;101(1):70-5. doi: 10.1111/j.1572-0241.2005.00307.x.

    PubMed 16405536

  • Vis, D.J., et al., Analyzing metabolomics-based challenge tests. Metabolomics, 2015. 11(1): p. 50-63.

  • Krug S, Kastenmuller G, Stuckler F, Rist MJ, Skurk T, Sailer M, Raffler J, Romisch-Margl W, Adamski J, Prehn C, Frank T, Engel KH, Hofmann T, Luy B, Zimmermann R, Moritz F, Schmitt-Kopplin P, Krumsiek J, Kremer W, Huber F, Oeh U, Theis FJ, Szymczak W, Hauner H, Suhre K, Daniel H. The dynamic range of the human metabolome revealed by challenges. FASEB J. 2012 Jun;26(6):2607-19. doi: 10.1096/fj.11-198093. Epub 2012 Mar 16.

    PubMed 22426117

  • LaBarre JL, Singer K, Burant CF. Advantages of Studying the Metabolome in Response to Mixed-Macronutrient Challenges and Suggestions for Future Research Designs. J Nutr. 2021 Oct 1;151(10):2868-2881. doi: 10.1093/jn/nxab223.

    PubMed 34255076

  • Yu EA, Yu T, Jones DP, Ramirez-Zea M, Stein AD. Metabolomic Profiling After a Meal Shows Greater Changes and Lower Metabolic Flexibility in Cardiometabolic Diseases. J Endocr Soc. 2020 Aug 25;4(11):bvaa127. doi: 10.1210/jendso/bvaa127. eCollection 2020 Nov 1.

    PubMed 33134764

  • Sebedio, j.-l. and S. Polakof, Using metabolomics to identify biomarkers for metabolic diseases: Analytical methods and applications. 2015. p. 145-166.

Questions about this trial

What is this clinical trial studying?

A study testing High carbohydrate challenge, High lipid challenge and High proteinchallenge in people with Fasting and Postprandial Hyperglycemia, run by Instituto Nacional de Medicina Genomica at 1 site in Mexico.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 17 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Mexico. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Berenice Palacios-Gonzalez, PhD (5553501900 ext. 1451, bpalacios@inmegen.gob.mx), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Metabolic Flexibility Assessed by Respiratory Quotient (RQ) and Substrate Oxidation (time frame: Once a week for three weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06878781, which also lists 32 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Mar 2025.

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