Metabolism DisorderNCT05784506
Metabolites Profiling Reveals Nutrient Processing Patterns Upon Dietary Loading
A study testing Macronutrients and Mixed meal tolerance test (MMTT) in people with Metabolism Disorder and Nutrition, run by Nanjing Medical University at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 20 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Metabolism Disorder, Nutrition
- What is being tested?
- Macronutrients and Mixed meal tolerance test (MMTT)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 147 participants
- Where
- 1 siteChina
- Study dates
- 1 Sep 2023to 31 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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:
Show all 15Show fewer
- 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.
- Hepatic excretion dysfunction (eg. hyperbilirubinemia) and/or synthesis dysfunction, or other decompensated liver disease.
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site
First Affiliated Hospital, Nanjing Medical University
Nanjing, Jiangsu, 210029
About this study
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
- Being tested
- Macronutrients, Mixed meal tolerance test (MMTT)
- Medical subject headings
- Metabolic Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MacronutrientsOther
Four successive food tolerance tests (glucose, protein, butter and olive oil) at one-week intervals.
Mixed meal tolerance test (MMTT)Other
Mixed meal tolerance test (MMTT)
| Study group | Role | What they receive |
|---|---|---|
| Macronutrients loading test for healthy group | Experimental | 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. Receives: Other: Macronutrients |
| Mixed meal tolerance test (MMTT) for healthy group | Experimental | A total of 40 subjects with normal weight and plasma glucose levels underwent MMTT. Receives: Other: Mixed meal tolerance test (MMTT) |
| Mixed meal tolerance test (MMTT) for overweight subjects with normal plasma glucose | Experimental | A total of 40 overweight subjects without a history of diabetes underwent MMTT. Receives: Other: Mixed meal tolerance test (MMTT) |
| Mixed meal tolerance test (MMTT) for obese subjects with abnormal plasma glucose | Experimental | A total of 40 obese subjects without a history of diabetes underwent MMTT. Receives: Other: Mixed meal tolerance test (MMTT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Metabolites
Plasma metabolites after dietary loading.
Measured: 0 to 180 minutes after a dietary loading
Endocrine hormones
Plasma insulin and C-peptide after dietary loading.
Measured: 0 to 180 minutes after a dietary loading
Proteomics
Plasma proteomics after dietary loading.
Measured: 0 to 180 minutes after a dietary loading
Lipidomics
Plasma lipidomics after dietary loading.
Measured: 0 to 180 minutes after a dietary loading
Diet questionnaire
Diet questionnaire
Measured: 3 days
Stool microbiome
Metagenomic sequencing and 16s microbiome sequencing
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2023
- Study start1 Sep 2023
- Primary completion30 Nov 2023
- Study completion31 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metabolism DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 147 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nanjing Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yang Tao, Nanjing Medical University
- Investigators
- Tao Yang, MD/PhD, Study chair, First Affiliated Hospital, Nanjing Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05784506
- Sponsor's protocol ID
- 2021-SR-298
- Status last verified
- Sep 2025
- First submitted
- 20 Feb 2023
- Last updated
- 18 Sep 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Metabolites Profiling Reveals Nutrient Processing Patterns Upon Dietary Loading
- ClinicalTrials.gov ID
- NCT05784506
- Acronym / sponsor ID
- 2021-SR-298
- Conditions
- Metabolism Disorder, Nutrition
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 147 participants (actual)
- Lead sponsor
- Nanjing Medical UniversityUniversity, hospital or other
- Study start
- 1 Sep 2023 (actual)
- Primary completion
- 30 Nov 2023 (actual)
- Study completion
- 31 Dec 2023 (actual)
- First posted
- 27 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Macronutrients loading test for healthy group | Experimental | Other: MacronutrientsA total of 30 subjects with normal metabolic status underwent four successive food tolerance tests (glucose, protein, butter and olive oil) at one-week intervals. |
| Mixed meal tolerance test (MMTT) for healthy group | Experimental | Other: 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 | Experimental | Other: 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 | Experimental | Other: Mixed meal tolerance test (MMTT)A total of 40 obese subjects without a history of diabetes underwent MMTT. |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (15 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MacronutrientsFour successive food tolerance tests (glucose, protein, butter and olive oil) at one-week intervals. | Other | Macronutrients loading test for healthy group |
| Mixed meal tolerance test (MMTT)Mixed meal tolerance test (MMTT) | Other | Mixed meal tolerance test (MMTT) for healthy group, Mixed meal tolerance test (MMTT) for obese subjects with abnormal plasma glucose, Mixed meal tolerance test (MMTT) for overweight subjects with normal plasma glucose |
Primary outcome
Metabolites
Time frame: 0 to 180 minutes after a dietary loading
Plasma metabolites after dietary loading.
Endocrine hormones
Time frame: 0 to 180 minutes after a dietary loading
Plasma insulin and C-peptide after dietary loading.
Proteomics
Time frame: 0 to 180 minutes after a dietary loading
Plasma proteomics after dietary loading.
Lipidomics
Time frame: 0 to 180 minutes after a dietary loading
Plasma lipidomics after dietary loading.
Diet questionnaire
Time frame: 3 days
Diet questionnaire
Stool microbiome
Time frame: Baseline
Metagenomic sequencing and 16s microbiome sequencing
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tao Yang, MD/PhD study chair
First Affiliated Hospital, Nanjing Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Macronutrients and Mixed meal tolerance test (MMTT) in people with Metabolism Disorder and Nutrition, run by Nanjing Medical University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Metabolites (time frame: 0 to 180 minutes after a dietary loading). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Sep 2025.