- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06129578
Plant Protein Supplementation Within a Healthy Lifestyle Modulates Plasma Circulating Amino Acids and Improves the Health Status of Overweight Individuals
A dietary pattern based on Mediterranean diet has been reported as healthy for humans, as well as doing aerobic exercise regularly, diminishing the development of potential inflammation in subjects. Protein intake has been proposed as nutritional strategy to further improve these positives outcomes in terms of preventing inflammation diseases. In this work, overweight patients followed a Mediterranean diet together with aerobic exercise according to WHO-guidelines and were supplemented with 20 g of hemp protein/day, for twelve weeks.
Anthropometric and biochemical measures (including analysis of oligoelements), as well as plasma circulating amino acids were evaluated in each patient at the end of the intervention, to assess whether biologically relevant changes could be observed.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Seville, Spain, 41009
- University of Seville
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- age between 18 and 65 years old
- waist circumference ≥94cm in men and ≥88cm in women
- MET<4
Exclusion Criteria:
- prediabetic patients on pharmacotherapy
- subjects suffering from medical issues (e.g., diabetes or another chronic disease)
- smokers
- pregnant or lactating women.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: N/A
- Interventional Model: Sequential Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Evolution of cytokines in intervention
Time Frame: [Time Frame: Up to 6 hours]
|
Pro-inflammatory and anti-inflammatory cytokines, including NFα, IL-1β, IL-6, IL-8, IL-10, ICAM-1, MCP-1, leptin, and adiponectin, in plasma will be measured using appropriate methods (EIA, ELISA, and/or Bioplex multiplex system) (mg/dl).
|
[Time Frame: Up to 6 hours]
|
Effect of the intervention on subjects' biochemical measures
Time Frame: [Time Frame: Up to 6 hours]
|
Total cholesterol and triglycerides (TAG) (mg/dL) were determined by enzymatic methods (CHOD-PAP and GPO-PAP, respectively; Roche Diagnostics, Basel, Switzerland).
High density lipoprotein-cholesterol (HDL-C) (mg/dL= was determined after precipitation with phosphotungstic acid.
Low-density lipoprotein cholesterol (LDL-C) (mg/dL) was calculated with the Firedewald formula.
Blood glucose levels, measured by biochemical procedures (mg/dL).
|
[Time Frame: Up to 6 hours]
|
Effect of the intervention on the serum amino acid levels of the subjects.
Time Frame: [Time Frame: Up to 6 hours]
|
The amino acid content in plasma (μmol/L) samples analyses were carried out in the University of Sevilla (General Microanalysis Research Service), using an amino acid analyzer BIOCHROM 30, following an amino acid analysis method based on ion exchange chromatography with post column derivatization with ninhydrin.
|
[Time Frame: Up to 6 hours]
|
Effect of the intervention on the serum mineral levels of the subjects.
Time Frame: [Time Frame: Up to 6 hours]
|
Mineral content (μgl/L) was evaluated using UV or colorimetrics commercial kits (Bioscience Medical).
|
[Time Frame: Up to 6 hours]
|
Collaborators and Investigators
Sponsor
Collaborators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2246-N-20
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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