Metabolites Profiling Reveals Nutrient Processing Patterns Upon Dietary Loading

• Sponsor: Nanjing Medical University (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05784506
• Collaborator: (none)
• Enrollment: 150
• Location: 1
• Arms: 4
• Anticipated Duration (Months): 9
• Patients Per Site Per Month: 16.6

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Metabolism Disorder; Nutrition	Other: Macronutrients; Other: Mixed meal tolerance test (MMTT)	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 150 participants
• Allocation: Non-Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Basic Science
• Official Title: Metabolites Profiling Reveals Nutrient Processing Patterns Upon Dietary Loading
• Anticipated Study Start Date: Mar 31, 2023
• Anticipated Primary Completion Date: Jul 31, 2023
• Anticipated Study Completion Date: Dec 31, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Macronutrients loading test for healthy group A total of 30 subjects with normal metabolic status underwent three successive food tolerance tests (glucose, protein and fat) at one-week intervals.	Other: Macronutrients; Three successive food tolerance tests (glucose, protein and fat) at one-week intervals.
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)

Outcome Measures

Primary Outcome Measures

1. Metabolites [Change from plasma metabolites during 180 minutes.]

   Plasma metabolites after dietary loading.

2. Endocrine hormones [Change from plasma insulin and C-peptide during 180 minutes.]

   Plasma insulin and C-peptide after dietary loading.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 20 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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:

1. 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.

1. Hepatic excretion dysfunction (eg. hyperbilirubinemia) and/or synthesis dysfunction, or other decompensated liver disease.

2. Acute viral hepatitis, autoimmune hepatitis, and alcoholic hepatitis

1. 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).

2. New York Heart Association (NYHA) functional class III or IV congestive heart failure.

3. History of acute or chronic pancreatitis.

4. History of gastrointestinal disorders: gastroenterostomy, enterectomy, ileus and intestinal ulcers.

5. Subjects with previously diagnosed malignancy within the past 5 years.

6. Any other reasons that the investigator considered inappropriate to participate in the study.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	First Affiliated Hospital, Nanjing Medical University	Nanjing	Jiangsu	China	210029

Sponsors and Collaborators

• Nanjing Medical University

Investigators

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

Study Documents (Full-Text)

• Informed Consent Form - Jul 1, 2021

More Information

Publications

None provided.

• Responsible Party: Yang Tao, Professor, Chief physician, Nanjing Medical University
• ClinicalTrials.gov Identifier: NCT05784506
• Other Study ID Numbers: 2021-SR-298
• First Posted: Mar 27, 2023
• Last Update Posted: Mar 27, 2023
• Last Verified: Mar 1, 2023

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Metabolic Diseases

Study Results

No Results Posted as of Mar 27, 2023