Metabolites Profiling Reveals Nutrient Processing Patterns Upon Dietary Loading

Not Applicable

Not yet recruiting

• Conditions: Nutrition; Metabolism Disorder
• Interventions: Other: Macronutrients; Other: Mixed meal tolerance test (MMTT)

• Registration Number: NCT05784506
• Lead Sponsor: Nanjing Medical University

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-02-20
• Status Verified: 2023-03
• Study First Submitted QC: 2023-03-13
• Last Update Submitted: 2023-03-13
• Study First Posted: 2023-03-27
• Last Update Posted: 2023-03-27
• Study Start: 2023-03-31
• Primary Completion: 2023-07-31
• Study Completion: 2023-12-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 150

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Macronutrients loading test for healthy group	Macronutrients	A total of 30 subjects with normal metabolic status underwent three successive food tolerance tests (glucose, protein and fat) at one-week intervals.
Mixed meal tolerance test (MMTT) for healthy group	Mixed meal tolerance test (MMTT)	A total of 40 subjects with normal weight and plasma glucose levels underwent MMTT.
Mixed meal tolerance test (MMTT) for overweight subjects with normal plasma glucose	Mixed meal tolerance test (MMTT)	A total of 40 overweight subjects without a history of diabetes underwent MMTT.
Mixed meal tolerance test (MMTT) for obese subjects with abnormal plasma glucose	Mixed meal tolerance test (MMTT)	A total of 40 obese subjects without a history of diabetes underwent MMTT.

Primary Outcome Measures

Name	Time	Method
Metabolites	Change from plasma metabolites during 180 minutes.	Plasma metabolites after dietary loading.
Endocrine hormones	Change from plasma insulin and C-peptide during 180 minutes.	Plasma insulin and C-peptide after dietary loading.

Trial Locations

Locations (1)

First Affiliated Hospital, Nanjing Medical University; 🇨🇳 Nanjing, Jiangsu, China