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

NCT ID: NCT06129578

Last Updated: 2023-11-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 27 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-01-01
• Study Completion Date: 2022-09-01

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.

Conditions

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

Study Design

• Allocation Method: NA
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Interventions

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.

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Spanish National Research Council

OTHER_GOV

Sponsor Role: collaborator

Sergio Montserrat de la Paz

OTHER

Sponsor Role: lead

Responsible Party

Sergio Montserrat de la Paz

Professor

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

University of Seville

Seville, , Spain

Countries

Spain

Other Identifiers

2246-N-20

Identifier Type: -

Identifier Source: org_study_id