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Metabolites Profiling Reveals Nutrient Processing Patterns Upon Dietary Loading

Primary Purpose

Metabolism Disorder, Nutrition

Status
Not yet recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Macronutrients
Mixed meal tolerance test (MMTT)
Sponsored by
Nanjing Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Metabolism Disorder

Eligibility Criteria

20 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: 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. Exclusion Criteria: 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.

Sites / Locations

  • First Affiliated Hospital, Nanjing Medical University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Experimental

Arm Label

Macronutrients loading test for healthy group

Mixed meal tolerance test (MMTT) for healthy group

Mixed meal tolerance test (MMTT) for overweight subjects with normal plasma glucose

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

Arm Description

A total of 30 subjects with normal metabolic status underwent three successive food tolerance tests (glucose, protein and fat) at one-week intervals.

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

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

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

Outcomes

Primary Outcome Measures

Metabolites
Plasma metabolites after dietary loading.
Endocrine hormones
Plasma insulin and C-peptide after dietary loading.

Secondary Outcome Measures

Full Information

First Posted
February 20, 2023
Last Updated
March 13, 2023
Sponsor
Nanjing Medical University
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1. Study Identification

Unique Protocol Identification Number
NCT05784506
Brief Title
Metabolites Profiling Reveals Nutrient Processing Patterns Upon Dietary Loading
Official Title
Metabolites Profiling Reveals Nutrient Processing Patterns Upon Dietary Loading
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
March 31, 2023 (Anticipated)
Primary Completion Date
July 31, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Nanjing Medical University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metabolism Disorder, Nutrition

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
150 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Macronutrients loading test for healthy group
Arm Type
Experimental
Arm Description
A total of 30 subjects with normal metabolic status underwent three successive food tolerance tests (glucose, protein and fat) at one-week intervals.
Arm Title
Mixed meal tolerance test (MMTT) for healthy group
Arm Type
Experimental
Arm Description
A total of 40 subjects with normal weight and plasma glucose levels underwent MMTT.
Arm Title
Mixed meal tolerance test (MMTT) for overweight subjects with normal plasma glucose
Arm Type
Experimental
Arm Description
A total of 40 overweight subjects without a history of diabetes underwent MMTT.
Arm Title
Mixed meal tolerance test (MMTT) for obese subjects with abnormal plasma glucose
Arm Type
Experimental
Arm Description
A total of 40 obese subjects without a history of diabetes underwent MMTT.
Intervention Type
Other
Intervention Name(s)
Macronutrients
Intervention Description
Three successive food tolerance tests (glucose, protein and fat) at one-week intervals.
Intervention Type
Other
Intervention Name(s)
Mixed meal tolerance test (MMTT)
Intervention Description
Mixed meal tolerance test (MMTT)
Primary Outcome Measure Information:
Title
Metabolites
Description
Plasma metabolites after dietary loading.
Time Frame
Change from plasma metabolites during 180 minutes.
Title
Endocrine hormones
Description
Plasma insulin and C-peptide after dietary loading.
Time Frame
Change from plasma insulin and C-peptide during 180 minutes.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Tao Yang, MD/PhD
Phone
86-25-83718836
Ext
6466
Email
yangt@njmu.edu.cn
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tao Yang, MD/PhD
Organizational Affiliation
First Affiliated Hospital, Nanjing Medical University
Official's Role
Study Chair
Facility Information:
Facility Name
First Affiliated Hospital, Nanjing Medical University
City
Nanjing
State/Province
Jiangsu
ZIP/Postal Code
210029
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tao Yang, MD/PhD
Phone
86-25-83718836
Ext
6466
Email
yangt@njmu.edu.cn

12. IPD Sharing Statement

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Metabolites Profiling Reveals Nutrient Processing Patterns Upon Dietary Loading

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