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Completed

NCT Number: 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.

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Key information

Conditions

Obesity Body Weight Glucose Metabolism Disorders Hyperinsulinism Immune System and Related Disorders Inflammation Insulin Resistance Metabolic Diseases Metabolic Disorder Metabolic Syndrome Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathologic Processes Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Seville

Seville, 41009, Spain

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Mediterranean diet supplement with 20 g / day of hemp protein.

Dietary Supplement

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.

Primary outcomes

  1. 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).

  2. 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).

  3. 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.

  4. 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).

Sponsors and collaborators

Lead sponsor

Sergio Montserrat de la Paz

Other

Collaborators

  • Spanish National Research Council

Registry information

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Nov 13, 2023
Registry last updated
Nov 13, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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