Metabolites Profiling Reveals Nutrient Processing Patterns Upon Dietary Loading

NCT ID: NCT05784506

Last Updated: 2025-09-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 147 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-09-01
• Study Completion Date: 2023-12-31

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

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Macronutrients

Intervention Type: OTHER

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

Mixed meal tolerance test (MMTT) for healthy group

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

Group Type: EXPERIMENTAL

Mixed meal tolerance test (MMTT)

Intervention Type: OTHER

Mixed meal tolerance test (MMTT)

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.

Group Type: EXPERIMENTAL

Mixed meal tolerance test (MMTT)

Intervention Type: OTHER

Mixed meal tolerance test (MMTT)

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.

Group Type: EXPERIMENTAL

Mixed meal tolerance test (MMTT)

Intervention Type: OTHER

Mixed meal tolerance test (MMTT)

Interventions

Macronutrients

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

Intervention Type: OTHER

Mixed meal tolerance test (MMTT)

Mixed meal tolerance test (MMTT)

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Nanjing Medical University

OTHER

Sponsor Role: lead

Responsible Party

Yang Tao

Professor, Chief physician

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Tao Yang, MD/PhD

Role: STUDY_CHAIR

First Affiliated Hospital, Nanjing Medical University

Locations

First Affiliated Hospital, Nanjing Medical University

Nanjing, Jiangsu, China

Countries

China

Provided Documents

Document Type: Informed Consent Form

View Document

Other Identifiers

2021-SR-298

Identifier Type: -

Identifier Source: org_study_id