Fasting Clinical Trial
Official title:
Evaluation of p21 Induction and Molecular Pathways Related to Short-term Fasting Response
NCT number | NCT04259879 |
Other study ID # | IMD PI0025 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | April 7, 2016 |
Est. completion date | June 15, 2016 |
Verified date | January 2020 |
Source | IMDEA Food |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This study will evaluate the effect of short-term fasting (36 hours) in gene expression in blood cells in healthy volunteers.
Status | Completed |
Enrollment | 20 |
Est. completion date | June 15, 2016 |
Est. primary completion date | May 18, 2016 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 50 Years |
Eligibility |
Inclusion Criteria: - Men and women between 18 - 50 years old. - BMI >20<30 - Adequate education level and comprehension of the clinical study - Willingness to participate in the study as a volunteer and to provide written consent Exclusion Criteria: - BMI <20 (thinness) - BMI >30 (obesity) - Abnormal low glucose levels after fasting - Having donated blood less than 8 weeks before starting the study - Subjects who report special discomfort after previous periods of short fasting - Diagnosis of type 2 Diabetes mellitus (insulin-dependent) - Dyslipidemia under pharmacological treatment - High blood pressure under pharmacological treatment - Dementia, neurological disease or reduction of cognitive function - Severe illness (hepatic disease, renal disease, etc - Taking medications that could affect the lipid and glycemic profiles (statins, fibrate, diuretics, corticoids, anti-inflammatory, hypoglycemic or insulin) 30 days before the beginning of the study. - Taking medications or substances for weight loss management (15 days before the beginning of the study) - Pregnancy or lactation |
Country | Name | City | State |
---|---|---|---|
Spain | IMDEA Food | Madrid |
Lead Sponsor | Collaborator |
---|---|
IMDEA Food | Centro Nacional de Investigaciones Oncologicas CARLOS III |
Spain,
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* Note: There are 22 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Changes in gene expression in PBMCs after fasting | Expression analysis of p21, Pyruvate Dehydrogenase Kinase 4 (PDK4), Carnitine palmitoyltransferase 1 (CPT1), Adipophilin (ADFP) and Solute carrier family 25, member 50 (SLC25A50) were performed in a HT-7900 Fast Real time polymerase chain reaction (PCR). Quantifications were made applying the ?Ct method (?Ct = [Ct of gene of interest - Ct of housekeeping]). The housekeeping genes used for input normalization were ß-actin (ACTB) and ribosomal protein lateral stalk subunit P0 (RPLP0). | Baseline, 24 hours and 48 hours later | |
Secondary | Changes in Insulin levels in response to fasting | Insulin levels (International Units per milliliter) were measured with a kit from Abbott Laboratories, by luminescent immunoassay using the Architect instrument from Abbott Laboratories. | Baseline, 24 hours and 48 hours later | |
Secondary | Changes in Free Fatty Acids levels in response to fasting | Free fatty acids levels (moles per milliliter) were evaluated with a kit from Abbott Laboratories, by enzymatic spectrophotometric assays using an Architect instrument from Abbott Laboratories. | Baseline, 24 hours and 48 hours later | |
Secondary | Changes ketone bodies in response to fasting | Ketone bodies concentration (moles per milliliter) will be measured with a kit from Sigma-Aldrich, by an enzymatic spectrophotometric assay using an microplate reader from Thermo Fisher. | Baseline, 24 hours and 48 hours later | |
Secondary | Changes in leptin levels in response to fasting | Leptin levels (nanograms per milliliter) were measured with a kit from Mercodia by a non-competitive automatic ELISA immunoanalysis | Baseline, 24 hours and 48 hours later | |
Secondary | Changes in lipid profile in response to fasting | To evaluate lipid improvements the following measurements were considered: Triacylglycerol, Total Cholesterol, low Density Lipoprotein and High-Density Lipoprotein measured by routine laboratory (CQS, Madrid, Spain) methods. | Baseline, 24 hours and 48 hours later | |
Secondary | Subjective evaluation of tolerance to fasting | To evaluate the tolerance to fasting, participants will fill in a fasting tolerance test based on the symptoms they feel, this will result in a final score of tolerance to fasting. | 36 hours of fasting |
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