Plant Protein Supplementation Within a Healthy Lifestyle Modulates Plasma Circulating Amino Acids and Improves the Health Status of Overweight Individuals

November 8, 2023 updated by: Sergio Montserrat de la Paz

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

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

27

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Seville, Spain, 41009
        • University of Seville

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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

This is where you will find people and organizations involved with this study.

Sponsor

Sergio Montserrat de la Paz

Collaborators

Spanish National Research Council

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2021

Primary Completion (Actual)

September 1, 2022

Study Completion (Actual)

September 1, 2022

Study Registration Dates

First Submitted

November 2, 2023

First Submitted That Met QC Criteria

November 8, 2023

First Posted (Actual)

November 13, 2023

Study Record Updates

Last Update Posted (Actual)

November 13, 2023

Last Update Submitted That Met QC Criteria

November 8, 2023

Last Verified

November 1, 2023

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)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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