Efficacy of a Training Program in Adults Following a Vegan Diet Versus an Omnivorous Diet (Vegan)

May 20, 2024 updated by: Universidad de Concepcion

Efficacy of an Omnivorous Versus a Vegan Diet in the Prevention or Treatment of Sarcopenia in Chilean Adults Following a Strength Training Program

The study consisted of a non-randomized controlled clinical trial with measurements at baseline and at the end of a 16 week intervention. Participants will be assigned to the intervention or control group according to their own choice and convenience. A 4 arm split was performed where the Veg-Int group was composed of people on a vegan diet who participated in the intervention, the Veg-Con group was composed of people on a vegan diet who were part of the control group, the Omn-Int group was composed of people on an omnivorous diet who participated in the intervention, and the Omn-Con group was composed of people on an omnivorous diet who were part of the control group.

The Veg-Int and Omn-Int intervention groups, participated in a physical exercise program in remote modality through a digital mHealth platform. During the 16 weeks of intervention, a total of 50 training sessions were carried out, distributed in three sessions per week, with a duration per session ranging from 40 to 50 minutes. The exercise program was designed and supervised by a physical education teacher and focused on strength training using body weight exercises targeting the major muscle groups, including upper body, lower body and abdominals. The platform recorded participants attendance and the time they spent on each exercise session. At the end of the sessions, participants had the option to evaluate and share their perception of effort during the workout through a Modified Borg scale (0-10). In addition, they were given the opportunity to communicate with the teacher via phone call, text message or e-mail, to receive feedback or raise doubts.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

All participants were evaluated in weeks 0 and 17, immediately after the intervention program, under the same conditions in terms of protocol, calibrated instruments and the same evaluator.

The evaluation of nutritional status was carried out using the body mass index (BMI, Kg/m2), while the waist circumference was measured by passing a measuring tape at the height of the navel, midpoint between the costal margin and the crest. iliac, at the end of a normal expiration and recorded in centimeters.

Body composition analysis was obtained by the bioimpedance method, using a segmented bioimpedance meter. The measurements were carried out under fasting conditions for at least 4 hours, without having performed physical exercise in the last 12 hours, without consuming stimulating drinks such as caffeine and avoiding the menstrual period. From the body composition information, the data Percentage of Fat Mass, Kilos of Fat Mass and Kilos of Lean Mass were recorded.

The level of physical activity was assessed through a self-report questionnaire of physical activity and sitting time in the last 7 days, using the abbreviated version of the International Physical Activity Questionnaire (. The questionnaire was administered by a physical activity professional, and the data were reported in minutes per day to estimate the total PA performed, and the time reported was corrected by its metabolic equivalent .

The type of diet was corroborated through a quantified food consumption trend survey, which included 14 groups; vegetables, fruits, dairy and vegetable options, meat-fish-seafood and egg, legumes, vegan protein preparations, grains and cereals, fats and oils, nuts, sugars and sweets, alcohol, snacks, coffee and infusions, food supplements. The questionnaire was administered individually by a dietitian nutritionist to each participant.

Study Type

Interventional

Enrollment (Actual)

83

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Concepcion
      • Concepción, Concepcion, Chile, 4030000
        • Richar Carcamo Regla

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:People between 18 and 59 years old who follow a vegan or omnivorous diet for at least the last 6 months prior to the study.

- Exclusion Criteria: Those who were doing strength training or doing less than 3 hours of vigorous exercise per week did not have health compatible with the activities of this study. People with a diagnosis of diabetes, uncontrolled hypertension (Systolic Blood Pressure ≥150 and/or Diastolic Blood Pressure ≥90 mmHg). People who were undergoing treatment for cancer, chronic kidney failure, or who reported a health problem in the previous fitness for physical activity questionnaire (PAR-Q).

-

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Vegan Intervention
The intervention group is composed of people who follow a vegan diet and who will be part of an intervention program for 16 weeks, consisting of a physical exercise program of strength resistance with 3 sessions per week. Each session will be guided by a physical activity professional and will last from 45 to 50 minutes.
Strength training program to be developed during 16 weeks. There will be 3 exercise sessions per week and those participants who perform at least 2 sessions during the program will be considered for the statistical analysis.
Experimental: omnivorous intervention
The intervention group is composed of people who follow a omnivorous diet and who will be part of an intervention program for 16 weeks, consisting of a physical exercise program of strength resistance with 3 sessions per week. Each session will be guided by a physical activity professional and will last from 45 to 50 minutes.
Strength training program to be developed during 16 weeks. There will be 3 exercise sessions per week and those participants who perform at least 2 sessions during the program will be considered for the statistical analysis.
No Intervention: vegan control
People who follow an vegan diet who were part of the control group. They were evaluated before and after the intervention.
No Intervention: omnivorous control
People who follow an omnivorous diet who were part of the control group. They were evaluated before and after the intervention.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Body weight
Time Frame: 16 weeks of intervention
Differential between kg of body weight before and after the development of the intervention
16 weeks of intervention
waist circumference
Time Frame: 16 weeks of intervention
Differential between centimeters of waist circumference before and after the development of the intervention
16 weeks of intervention
fat mass
Time Frame: 16 weeks of intervention
Differential of the percentage of fat mass before and after the intervention
16 weeks of intervention
Lean mass
Time Frame: 16 weeks of intervention
Differential of kilograms of lean mass before and after the intervention
16 weeks of intervention
maximum strength
Time Frame: 16 weeks of intervention
Differential of kilograms of maximum strength by biceps curl exercise
16 weeks of intervention
Manual grip strength
Time Frame: 16 weeks of intervention
Differential of manual grip strength of both hands using a hydraulic dynamometer.
16 weeks of intervention
Vertical jump
Time Frame: 16 weeks of intervention
Differential evaluation of muscle power by means of a vertical jump
16 weeks of intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Study Director: Rafael E Zapata Lamana, Doctor, Universidad de Concepcion

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 2, 2022

Primary Completion (Actual)

May 2, 2022

Study Completion (Actual)

October 30, 2022

Study Registration Dates

First Submitted

May 15, 2024

First Submitted That Met QC Criteria

May 20, 2024

First Posted (Actual)

May 21, 2024

Study Record Updates

Last Update Posted (Actual)

May 21, 2024

Last Update Submitted That Met QC Criteria

May 20, 2024

Last Verified

May 1, 2024

More Information

Terms related to this study

Other Study ID Numbers

  • CEBB 1068-2021

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Has not been considered or discussed yet

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Physical Activity

Clinical Trials on Strength training program

3
Subscribe