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

Not Applicable

Completed

• Conditions: Metabolic Disorder; Immune System and Related Disorders; Obesity; Metabolic Syndrome; Inflammation

• Registration Number: NCT06129578
• Lead Sponsor: Sergio Montserrat de la Paz

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-01-01
• Primary Completion: 2022-09-01
• Study Completion: 2022-09-01
• Status Verified: 2023-11
• Study First Submitted: 2023-11-02
• Study First Submitted QC: 2023-11-08
• Last Update Submitted: 2023-11-08
• Study First Posted: 2023-11-13
• Last Update Posted: 2023-11-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 27

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Primary Outcome Measures

Name	Time	Method
Evolution of cytokines in intervention	[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).
Effect of the intervention on the serum mineral levels of the subjects.	[Time Frame: Up to 6 hours]	Mineral content (μgl/L) was evaluated using UV or colorimetrics commercial kits (Bioscience Medical).
Effect of the intervention on subjects' biochemical measures	[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).
Effect of the intervention on the serum amino acid levels of the subjects.	[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.

Trial Locations

Locations (1)

University of Seville; 🇪🇸 Seville, Spain