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CompletedNCT05784506Updated Sep 18, 2025

Metabolites Profiling Reveals Nutrient Processing Patterns Upon Dietary Loading

An interventional study of Macronutrients and Mixed meal tolerance test (MMTT) in Metabolism Disorder and Nutrition, sponsored by Nanjing Medical University. Completed at 1 site in China. Open to participants aged 20 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-09-18.

Sponsored by Nanjing Medical University · Not applicable, Interventional, and Basic science

Phase
Not applicable
Study type
Interventional
Enrollment
147
Allocation
Non-randomized
Ages
20 Years to 65 Years
Sex
All
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Study summary

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.

02

Conditions studied

  • Metabolism Disorder
  • Nutrition

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03

In context

Metabolic Diseases

997 studies on the registry are indexed under Metabolic Diseases; 234 are open to participants now.

This study's enrollment of 147 is above the median of 48 across 670 interventional studies indexed under Metabolic Diseases.

Browse Metabolic Diseases studies →

Lead sponsor

Nanjing Medical University is the lead sponsor of 169 studies on the registry; 51 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

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

  6. 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

  7. 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).
  8. New York Heart Association (NYHA) functional class III or IV congestive heart failure.
  9. History of acute or chronic pancreatitis.
  10. History of gastrointestinal disorders: gastroenterostomy, enterectomy, ileus and intestinal ulcers.
  11. Subjects with previously diagnosed malignancy within the past 5 years.
  12. Any other reasons that the investigator considered inappropriate to participate in the study.
05

Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Non-randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
147 participants (actual)

Study arms

  • Experimental
    Macronutrients loading test for healthy group

    A total of 30 subjects with normal metabolic status underwent four successive food tolerance tests (glucose, protein, butter and olive oil) at one-week intervals.

    Other: Macronutrients

  • Experimental
    Mixed meal tolerance test (MMTT) for healthy group

    A total of 40 subjects with normal weight and plasma glucose levels underwent MMTT.

    Other: Mixed meal tolerance test (MMTT)

  • Experimental
    Mixed meal tolerance test (MMTT) for overweight subjects with normal plasma glucose

    A total of 40 overweight subjects without a history of diabetes underwent MMTT.

    Other: Mixed meal tolerance test (MMTT)

  • Experimental
    Mixed meal tolerance test (MMTT) for obese subjects with abnormal plasma glucose

    A total of 40 obese subjects without a history of diabetes underwent MMTT.

    Other: Mixed meal tolerance test (MMTT)

Interventions

  • OtherMacronutrients

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

  • OtherMixed meal tolerance test (MMTT)

    Mixed meal tolerance test (MMTT)

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What researchers measure

Primary outcomes

  1. Metabolites

    Plasma metabolites after dietary loading.

    Time frame: 0 to 180 minutes after a dietary loading

  2. Endocrine hormones

    Plasma insulin and C-peptide after dietary loading.

    Time frame: 0 to 180 minutes after a dietary loading

  3. Proteomics

    Plasma proteomics after dietary loading.

    Time frame: 0 to 180 minutes after a dietary loading

  4. Lipidomics

    Plasma lipidomics after dietary loading.

    Time frame: 0 to 180 minutes after a dietary loading

  5. Diet questionnaire

    Diet questionnaire

    Time frame: 3 days

  6. Stool microbiome

    Metagenomic sequencing and 16s microbiome sequencing

    Time frame: Baseline

07

Study locations

1 site
  • First Affiliated Hospital, Nanjing Medical University
    Nanjing, Jiangsu 210029, China
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References and documents

Study documents

  • Informed consent form · Jul 1, 2021

Documents are hosted by the registry — open the source record to download them.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 18, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT05784506
Lead sponsor
Nanjing Medical University
Responsible party
Yang Tao (Professor, Chief physician, Nanjing Medical University) — Principal investigator
First posted
Mar 27, 2023
Start date
Sep 1, 2023
Primary completion
Nov 30, 2023
Completion
Dec 31, 2023
Last update
Sep 18, 2025

Study contacts

Tao Yang, MD/PhD
study chair · First Affiliated Hospital, Nanjing Medical University

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2025. You cannot join it, but the record below documents what was studied.

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