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

Study Overview
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Brief Summary
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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.

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

Conditions
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Obesity, Metabolic Syndrome, Metabolic Disorder, Inflammation, Immune System and Related Disorders

Intervention / Treatment
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* Dietary Supplement: Mediterranean diet supplement with 20 g / day of hemp protein.


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Intervention Model: Sequential Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Dietary Supplement: Mediterranean diet supplement with 20 g / day of hemp protein.|All participants followed a low-energy diet (1315 kcal/daily) based on Mediterranean diet for 12 weeks, supplement with 20 g / day of hemp protein. The specific menu was designed by a trainee nutritionist. The program prescribed five meals a day, with the time customized to fit the lifestyle of each patient. Based on the baseline metabolism, the energy and nutritional parameters of every patient were computed. Patients reported the dietary intake data daily. The intervention included face to face visit every two weeks, individual nutrition counseling and education sessions.|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evolution of cytokines in intervention | 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 | 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. | 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. | Mineral content (μgl/L) was evaluated using UV or colorimetrics commercial kits (Bioscience Medical). | [Time Frame: Up to 6 hours] |