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Healthy Volunteers clinical trials

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NCT ID: NCT04044118 Completed - Healthy Volunteer Clinical Trials

Calorie Restriction Intervention Induces Enterotype-associated BMI Loss in Nonobese Individuals

CRDI
Start date: April 1, 2017
Phase: N/A
Study type: Interventional

Calorie restriction (CR), which has the potential effect on weight loss and blood amino acids, has been demonstrated to associate with gut microbiota in humans, especially in obese individuals. However, studies for simultaneously evaluating enterotype-dependent impacts of CR on the gut microbiota and blood amino acids in nonobese individuals are still limited. Here, 41 nonobese individuals received a 3-week CR diet with approximately 50% fewer calories than a normal diet. The investigators measured individuals' BMI and blood amino acid concentration, along with the gut microbiota before and after the intervention. In this trial, 28 Enterotype Bacteroides (ETB) subjects and 13 Enterotype Prevotella (ETP) subjects were identified before the intervention. The purpose of this intervention study is to evaluate the effect of calorie restriction on BMI loss, amino acid, and gut microbiota in healthy volunteers of two different enterotypes and provide useful insights for potential application of gut microbiome stratification in personalized nutrition intervention.

NCT ID: NCT04042428 Completed - Healthy Volunteers Clinical Trials

Generation of Biological Samples Positive to Somatropin for Anti-doping Control

GH5
Start date: October 25, 2019
Phase: Phase 1
Study type: Interventional

Background: Somatropin, also known as recombinant growth hormone (rhGH), is one of the World Anti-Doping Agency (WADA) prohibited substances. Its consumption in athletes has been banned since 1990, as it is known to improve physical performance. Hypothesis: The subcutaneous administration of recombinant somatropin (rhGH) in healthy subjects allows obtaining positive doping samples. The concentrations of hGH variants (isoforms) and biomarkers can be measured in serum. Objectives: Primary objective: To generate enough serum samples positive to recombinant somatropin in order to be analyzed as control samples by anti-doping laboratories. Secondary objective: To determine the analytical parameters necessary to detect the administration of recombinant somatropin in healthy volunteers by direct and/or indirect methods. Methods: Phase I, open, randomized clinical trial, with a treatment condition (recombinant somatropin or rhGH) administered subcutaneously to 4 subjects (2:1 ratio). Control samples of the study correspond to basal samples of 2 subjects who do not receive any treatment.

NCT ID: NCT04036162 Completed - Healthy Volunteers Clinical Trials

Spatial and Dynamic Characterization of Brain Activity for Language and Posture (Verticality) During Normal Aging. Magnetoencephalography (MEG) Study (MEG-AGING)

MEG-AGING
Start date: October 1, 2019
Phase: N/A
Study type: Interventional

Depending on the point of view, different definitions of aging have been proposed. Thus, at the biological level, aging corresponds to a natural physiological process that leads to the progressive degeneration of cells and the slowing down of the vital functions of a living organism. More generally, aging is a multifactorial and multidimensional process that occurs at the cognitive, social, biological or psychological level. The primary objective of this study is to evaluate the balance between activation (Task-Positive Network : TPN-Language, L, TPN-Verticality, V) and rest (Task-Negative Network : TNN) activity during normal aging, in two domains (language and posturo-spatial perception of verticality).

NCT ID: NCT04034290 Completed - Healthy Volunteers Clinical Trials

A Double-blind Randomized Placebo-controlled Study Study of the Safety, Reactogenicity and Immunogenicity of the GamFluVac

Start date: October 18, 2019
Phase: Phase 2
Study type: Interventional

The aim of the present study is at the first stage: a comparative assessment of the safety of the two methods of vaccine administration, at the second - an assessment of the safety and state of post-vaccination immunity at different times after vaccination

NCT ID: NCT04025580 Completed - Healthy Volunteer Clinical Trials

Systems Analyses of the Immune Response to the Seasonal Influenza Vaccine

Start date: October 2, 2019
Phase: Phase 2
Study type: Interventional

Background: Vaccines help prevent disease by causing the body to have an immune response. Many parts of this response happen in the blood. This response happens over days and weeks after getting the vaccine. Researchers want to how the blood changes over time in response to vaccines. They want to find out why vaccines work better for some people than for others. This could help make more effective vaccines. Objective: To learn about how the body responds to vaccines. Eligibility: Healthy people ages 18 and older Design: Participants will be screened with a medical history, physical exam, and blood and urine tests. Participants will have 9 visits over 6 months. All visits will include blood tests and a physical exam. Participants will have the first visit 1 week before they get the vaccine. Participants will get the flu vaccine at the second visit. The vaccine will be injected into the muscle of the upper arm with a needle. They will be watched for side effects for 15 minutes. Participants will have the next 2 visits exactly 1 day and 1 week after they get the vaccine. They will have the other 5 visits about 14, 28, 70, and 100 days after they get the vaccine. Participants will take email questionnaires about whether they had any side effects. Participants may have optional extra study visits. These will be no more than once a month for up to 1 year after they get the vaccine. Optionally, they can also repeat the study each year through the 2023 - 2024 flu season

NCT ID: NCT04024228 Completed - Healthy Volunteers Clinical Trials

Study to Assess the Immune Response and the Safety Profile of a High-Dose Quadrivalent Influenza Vaccine (QIV-HD) Compared to a Standard-Dose Quadrivalent Influenza Vaccine (QIV-SD) in Europeans Adults 60 Years of Age and Older

Start date: October 28, 2019
Phase: Phase 3
Study type: Interventional

Primary Objective: To demonstrate that high-dose quadrivalent influenza vaccine (QIV-HD) induces an immune response that is superior to the responses induced by standard-dose quadrivalent influenza vaccine (QIV-SD) for all 4 virus strains 28 days post-vaccination in participants 60 to 64 years of age and in participants 65 years of age and older. Secondary Objective: - Immunogenicity: To further describe the immune response induced by QIV-HD and QIV-SD in all participants by age group, in pooled age groups, and by vaccine group (QIV-HD; QIV-SD). - Safety: To describe the safety profile of all participants by age group, in pooled age groups, and by vaccine group (QIV-HD; QIV-SD).

NCT ID: NCT04022317 Completed - Healthy Volunteer Clinical Trials

Comparision of Pharmacokinetics(PK) and Pharmacodynamics(PD) of Biocon Insulin R and Humulin® R

Start date: June 18, 2019
Phase: Phase 1
Study type: Interventional

Single-centre, randomised, double-blind, single dose, two-treatment, two-period, two sequence, crossover,12-hour euglycaemic glucose clamp trial in healthy subjects

NCT ID: NCT04022304 Completed - Healthy Volunteer Clinical Trials

Comparision of Pharmacokinetic and Pharmacodynamic of Biocon Insulin N and Humulin® N

Start date: June 15, 2019
Phase: Phase 1
Study type: Interventional

Single-centre, randomised, double-blind, three-period, six-sequence, partially replicated design, crossover trial in healthy subjects

NCT ID: NCT04022291 Completed - Healthy Volunteer Clinical Trials

Comparison of Pharmacokinetic (PK) and Pharmacodynamic(PD) of Biocon Insulin 70/30 and Humulin® 70/30

Start date: June 15, 2019
Phase: Phase 1
Study type: Interventional

Two-centre, randomised, double-blind, single dose, two-treatment, two-period, two sequence, crossover, 24-hour euglycaemic glucose clamp trial in healthy subjects.

NCT ID: NCT04021563 Completed - Healthy Volunteers Clinical Trials

The Safety, Tolerability, Pharmacokinetics(PK) of SR419 in Healthy Volunteers

Start date: July 26, 2019
Phase: Phase 1
Study type: Interventional

This study is to evaluate the safety, tolerability, PK of SR419 in healthy volunteers.