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

Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06129578
• Other study ID #: 2246-N-20
• Status: Completed
• Phase: N/A
• Start date: January 1, 2021
• Est. completion date: September 1, 2022

Study information

• Verified date: November 2023
• Source: University of Seville
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 27
• Est. completion date: September 1, 2022
• Est. primary completion date: September 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

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

Intervention

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.

Locations

Country	Name	City	State
Spain	University of Seville	Seville

Sponsors (2)

Lead Sponsor	Collaborator
Sergio Montserrat de la Paz	Spanish National Research Council

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evolution of cytokines in intervention	Pro-inflammatory and anti-inflammatory cytokines, including NFa, IL-1ß, 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]
Primary	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]
Primary	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]
Primary	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]