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Target Mitochondrial Fitness, Chronobiology and Metabolism

Target Mitochondrial Fitness, Chronobiology and Metabolism

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05600192
Acronym
PI19/00507
Enrollment
100
Registered
2022-10-31
Start date
2021-10-18
Completion date
2023-12-31
Last updated
2022-11-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy Subjects

Keywords

Mitochondrial fitness, Metabolism, Chronobiology

Brief summary

Exercise could be an element that affects the biochemical, metabolic and microbiome parameters of organisms. Thus, to identify and validate the effects of aerobic and anaerobic exercises at different times of the day (morning or afternoon) on mitochondrial fitness and whether this changes could have a relation with metabolism and cardiovascular parameters and microbiome is of great interest for its applicability in biomedicine. As specific objectives of this project will study: 1. \- To study the direct effect of aerobic and anaerobic exercise at different time points in the day on mitochondria fitness (short study: basal, at the end of the exercise and 2 h after exercise). 2. \- To study mitochondria fitness under morning or afternoon aerobic and anaerobic exercise (prospective study: basal, 4, 8 and 12 weeks of the study). 3. \- To identify and validate modulators and target proteins of mitochondria fitness affected by exercise (miRNA omic and proteomic analysis of mitochondria from the different groups of the study at basal and 12 weeks of the study). 4. \- To study the relationship of the mitochondrial response (Objectives 1 and 2) to the different combination of exercises and chronobiology with anthropometric-clinical, carbohydrate and lipid metabolic and cardiovascular changes. 5. \- To check the effect of morning or afternoon aerobic and anaerobic exercise on gut microbiota and its relation to mitochondria fitness, clinical and metabolic parameters (basal, 4, 8 and 12 weeks of the study).

Interventions

OTHERAerobic or anaerobic exercise

Aerobic or anaerobic exercise in the morning or in the afternoon

Sponsors

Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
20 Years to 55 Years
Healthy volunteers
Yes

Inclusion criteria

* 20- * IMC \<30 kg/m2 * Informed consent

Exclusion criteria

* Smoker * Previous physical exercise of more than 20 minutes / 2 times a week

Design outcomes

Primary

MeasureTime frameDescription
Change in weightFrom baseline to week 12Weight in kg
BMI (body mass index) changesFrom baseline to week 12Measured by body composition analysis
Change in waist circumferenceFrom baseline to week 12Circumference in cm
Change in hip circumferenceFrom baseline to week 12Circumference in cm
Changes in diastolic and systolic blood pressureFrom baseline to week 12To analyze the effect of exercise on blood pressure
Changes in body compositionFrom baseline to week 12To analyze the effect of exercise on anthropometric parameters measured by bioelectrical impedance analysis
Change in glucose concentrationFrom baseline to week 12Glucose in mg/dl
Change in insulin concentrationFrom baseline to week 12Insulin in mg/dl
Change in glycated haemoglobin concentrationFrom baseline to week 12Glycated haemoglobin in mg/dl
Change in Triglycerides concentrationFrom baseline to week 12Triglycerides in mg/dl
Change in cholesterol concentrationFrom baseline to week 12Serum cholesterol in mg/dl
Change in HDL concentrationFrom baseline to week 12Serum HDL in mg/dl
Change in LDL concentrationFrom baseline to week 12Serum LDL in mg/dl
Change in transaminases concentrationFrom baseline to week 12Serum transaminases in UI/l
Change in creatinine concentrationFrom baseline to week 12Creatinine in mg/dl
Change in uric acid concentrationFrom baseline to week 12Uric acid in mg/dl
Change in alkaline phosphatase concentrationFrom baseline to week 12Serum alkaline phosphatase in UI/l
Change in bilirubin concentrationFrom baseline to week 12Serum bilirubin in mg/dl
Change in lactate concentrationFrom baseline to week 12Serum lactate in mmol/L
Change in cortisol concentrationFrom baseline to week 12Serum cortisol in nmol/L
Change in total and free testosterone concentrationFrom baseline to week 12Serum total and free testosterone in nmol/L
Change in melatonine concentrationFrom baseline to week 12Serum melatonine in pg/ml
Characterize exercise participant behaviorFrom baseline to week 12International Physical Activity Questionnaire (IPAQ). The IPAQ consists of 7 questions about the frequency, duration and intensity of activity (moderate and intense) carried out in the last seven days, as well as walking and sitting time in a work day. It evaluates three characteristics of physics (PA): intensity (mild, moderate or vigorous), frequency (days per week) and duration (time per day). Weekly activity is recorded in Mets (Metabolic Equivalent of Task or Metabolic Index Units) per minute and week.
Mediterranean diet adherence questionnaireFrom baseline to week 12To evaluate adherence to a Mediterranean diet pattern. It consists of 14 items in which different components of the Mediterranean diet are evaluated (number of pieces of fruit consumed per day, number of portions of legumes consumed per week...). Each item is scored as 0 or 1. A total score of \<9 indicates poor adherence, while a score of ≥9 indicates good adherence.
Change in faecal microbiotaFrom baseline to week 12To evaluate faecal microbiota composition in the studied subjects and the effect of aerobic and anaerobic exercise in the morning or afternoon on faecal microbiota composition. 16S rRNA amplicons of fecal community DNA
Change in fitness mitochondrialFrom baseline to week 12To evaluate the effect of aerobic and anaerobic exercise in the morning or afternoon on mitochondrial fitness, evaluated by mitochondrial gene expression and protein abundance, mitochondrial metabolites, mitochondrial markers trough flow citometry.

Countries

Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026