Metabolites Profiling Reveals Nutrient Processing Patterns Upon Dietary Loading

NCT05784506 | Completed

• 1 other identifier: 2021-SR-298
• Study Type: interventional
• Target: 147
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Metabolism Disorder; Nutrition

Outcome Measures

Primary Outcomes (6)

• 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

Study Arms (4)

Macronutrients loading test for healthy group

EXPERIMENTAL

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

Mixed meal tolerance test (MMTT) for healthy group

EXPERIMENTAL

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) for overweight subjects with normal plasma glucose

EXPERIMENTAL

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

Other: Mixed meal tolerance test (MMTT)

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

EXPERIMENTAL

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

Other: Mixed meal tolerance test (MMTT)

Interventions

Macronutrients OTHER

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

Macronutrients loading test for healthy group

Mixed meal tolerance test (MMTT) OTHER

Mixed meal tolerance test (MMTT)

Mixed meal tolerance test (MMTT) for healthy group; Mixed meal tolerance test (MMTT) for obese subjects with abnormal plasma glucose; Mixed meal tolerance test (MMTT) for overweight subjects with normal plasma glucose

Eligibility Criteria

• Age: 20 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Nanjing Medical University: lead

Study Sites (1)

First Affiliated Hospital, Nanjing Medical University

Nanjing, Jiangsu, 210029, China

Location

MeSH Terms

Conditions

Metabolic Diseases

Interventions

Nutrients

Condition Hierarchy (Ancestors)

Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• Tao Yang, MD/PhD

  First Affiliated Hospital, Nanjing Medical University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Chief physician

Study Record Dates

• First Submitted: February 20, 2023
• First Posted: March 27, 2023
• Study Start: September 1, 2023
• Primary Completion: November 30, 2023
• Study Completion: December 31, 2023
• Last Updated: September 18, 2025

Record last verified: 2025-09

Locations

CN (1)