Metabolism Disorder, Nutrition
Conditions
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.
Interventions
OTHERMacronutrients
Four successive food tolerance tests (glucose, protein, butter and olive oil) at one-week intervals.
Mixed meal tolerance test (MMTT)
Sponsors
Nanjing Medical University
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to 65 Years
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: 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Metabolites | 0 to 180 minutes after a dietary loading | Plasma metabolites after dietary loading. |
| Endocrine hormones | 0 to 180 minutes after a dietary loading | Plasma insulin and C-peptide after dietary loading. |
| Proteomics | 0 to 180 minutes after a dietary loading | Plasma proteomics after dietary loading. |
| Lipidomics | 0 to 180 minutes after a dietary loading | Plasma lipidomics after dietary loading. |
| Diet questionnaire | 3 days | Diet questionnaire |
| Stool microbiome | Baseline | Metagenomic sequencing and 16s microbiome sequencing |
Countries
China
Outcome results
None listed