Metabolites Profiling Reveals Nutrient Processing Patterns Upon Dietary Loading

Nutrition Clinical Trial

Official title:

Metabolites Profiling Reveals Nutrient Processing Patterns Upon Dietary Loading

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05784506
• Other study ID #: 2021-SR-298
• Status: Not yet recruiting
• Phase: N/A
• Start date: March 31, 2023
• Est. completion date: December 31, 2023

Study information

• Verified date: March 2023
• Source: Nanjing Medical University
• Contact: Tao Yang, MD/PhD
• Phone: 86-25-83718836
• Email: yangt[@]njmu.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 150
• Est. completion date: December 31, 2023
• Est. primary completion date: July 31, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Metabolic Diseases
• Metabolism Disorder
• Nutrition

Intervention

Other:
• Macronutrients
Three successive food tolerance tests (glucose, protein and fat) at one-week intervals.
• Mixed meal tolerance test (MMTT)
Mixed meal tolerance test (MMTT)

Locations

Country	Name	City	State
China	First Affiliated Hospital, Nanjing Medical University	Nanjing	Jiangsu

Sponsors (1)

Lead Sponsor	Collaborator
Nanjing Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Metabolites	Plasma metabolites after dietary loading.	Change from plasma metabolites during 180 minutes.
Primary	Endocrine hormones	Plasma insulin and C-peptide after dietary loading.	Change from plasma insulin and C-peptide during 180 minutes.