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

NCT06129578 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 27

Last updated 2023-11-13

No results posted yet for this study

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.

Conditions

  • Obesity
  • Metabolic Syndrome
  • Metabolic Disorder
  • Inflammation
  • Immune System and Related Disorders

Interventions

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.

Sponsors & Collaborators

  • Spanish National Research Council

    collaborator OTHER_GOV
  • Sergio Montserrat de la Paz

    lead OTHER

Study Design

Allocation
NA
Purpose
BASIC_SCIENCE
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-01-01
Primary Completion
2022-09-01
Completion
2022-09-01

Countries

  • Spain

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06129578 on ClinicalTrials.gov