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.

Study Overview

• Status: Completed
• Conditions: Nutrition; Metabolism Disorder
• Intervention / Treatment: Other: Mixed meal tolerance test (MMTT); Other: Macronutrients

• Study Type: Interventional
• Enrollment (Actual): 147
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Jiangsu
    • Nanjing, Jiangsu, China, 210029
      • First Affiliated Hospital, Nanjing Medical University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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:

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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); 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); 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); Mixed meal tolerance test (MMTT)
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; Four successive food tolerance tests (glucose, protein, butter and olive oil) at one-week intervals.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Metabolites	Plasma metabolites after dietary loading.	0 to 180 minutes after a dietary loading
Endocrine hormones	Plasma insulin and C-peptide after dietary loading.	0 to 180 minutes after a dietary loading
Proteomics	Plasma proteomics after dietary loading.	0 to 180 minutes after a dietary loading
Lipidomics	Plasma lipidomics after dietary loading.	0 to 180 minutes after a dietary loading
Diet questionnaire	Diet questionnaire	3 days
Stool microbiome	Metagenomic sequencing and 16s microbiome sequencing	Baseline

Collaborators and Investigators

• Sponsor: Nanjing Medical University
• Investigators: Study Chair: Tao Yang, MD/PhD, First Affiliated Hospital, Nanjing Medical University

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2023
• Primary Completion (Actual): November 30, 2023
• Study Completion (Actual): December 31, 2023

Study Registration Dates

• First Submitted: February 20, 2023
• First Submitted That Met QC Criteria: March 13, 2023
• First Posted (Actual): March 27, 2023

Study Record Updates

• Last Update Posted (Estimated): September 18, 2025
• Last Update Submitted That Met QC Criteria: September 13, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nutritional and Metabolic Diseases; Metabolic Diseases; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages; Nutrients
• Other Study ID Numbers: 2021-SR-298

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No