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Completed

NCT Number: NCT05784506

Metabolites Profiling Reveals Nutrient Processing Patterns Upon Dietary Loading

The reasonable combination of macronutrients including carbohydrates, proteins and fat, is the basis of rational diet and beneficial to treatment of metabolic diseases including obesity and diabetes. Endocrine hormones play pivotal roles in regulation of nutrients metabolism and energy homeostasis. However, the dynamic metabolism following the consumption of macronutrients and the relationship between various metabolites and endocrine hormones during these procedures yet to be adequately explained nowadays. Therefore, in this study, the investigators selected glucose, protein, fat and mixed meal tolerance test (MMTT) for the loading tests, endocrine hormones and metabolites were detected to profile the molecular changes in the plasma. The investigators aimed to explore the nutrient processing patterns of various macronutrients and determine the interaction between metabolic hormones and metabolites.

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Key information

Conditions

Metabolism Disorder Metabolic Diseases Nutrition Nutritional and Metabolic Diseases

Age range

20 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

First Affiliated Hospital, Nanjing Medical University

Nanjing, Jiangsu, 210029, China

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Those who agree to participate in the study and sign informed consent.
  • Age between 20 and 65 year.
  • Fasting plasma glucose < 7.0mmol/l, and 2-hour postprandial plasma glucose < 11.1mmol/l.
  • BMI > 18 kg/m2.

Exclusion criteria

  • History of diabetes.
  • Pregnant or lactating women.
  • The subjects had not received oral/systemic corticosteroids for 7 consecutive days during the last 6 months.
  • Subjects were taking medication known to affect glucose metabolism.
  • Subjects who take strong inhibitors of cytochrome P450 (CYP)3A4/5, for example, ketoconazole, azanaway, clarithromycin, indinavir, itraconazole, nefazodone, nelfinavir, ritonavir, saquinavir and telithromycin.
  • Patients with either of the following characteristics of severe hepatic disease:

i. Two consecutive abnormal hepatic function results during recent four weeks, with ALT or AST three times the upper limit of the institutions normal reference ranges.

ii. Hepatic excretion dysfunction (eg. hyperbilirubinemia) and/or synthesis dysfunction, or other decompensated liver disease.

iii. Acute viral hepatitis, autoimmune hepatitis, and alcoholic hepatitis

  • Patients with moderate and severe renal impairment, and end-stage renal disease (serum creatinine > 194.5 mmol/L, or serum potassium > 5.5 mmol/L).
  • New York Heart Association (NYHA) functional class III or IV congestive heart failure.
  • History of acute or chronic pancreatitis.
  • History of gastrointestinal disorders: gastroenterostomy, enterectomy, ileus and intestinal ulcers.
  • Subjects with previously diagnosed malignancy within the past 5 years.
  • Any other reasons that the investigator considered inappropriate to participate in the study.

Treatment and study plan

Macronutrients

Other

Four successive food tolerance tests (glucose, protein, butter and olive oil) at one-week intervals.

Mixed Meal Tolerance Test (MMTT)

Other

Mixed meal tolerance test (MMTT)

Primary outcomes

  1. Metabolites

    Time frame: 0 to 180 minutes after a dietary loading

    Plasma metabolites after dietary loading.

  2. Endocrine hormones

    Time frame: 0 to 180 minutes after a dietary loading

    Plasma insulin and C-peptide after dietary loading.

  3. Proteomics

    Time frame: 0 to 180 minutes after a dietary loading

    Plasma proteomics after dietary loading.

  4. Lipidomics

    Time frame: 0 to 180 minutes after a dietary loading

    Plasma lipidomics after dietary loading.

  5. Diet questionnaire

    Time frame: 3 days

    Diet questionnaire

  6. Stool microbiome

    Time frame: Baseline

    Metagenomic sequencing and 16s microbiome sequencing

Sponsors and collaborators

Lead sponsor

Nanjing Medical University

Other

Registry information

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Mar 27, 2023
Registry last updated
Sep 18, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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