Clinical trial NCT06423209: Efficacy of a Training Program in Adults Following a Vegan Diet Versus an Omnivorous Diet
Official title: Efficacy of an Omnivorous Versus a Vegan Diet in the Prevention or Treatment of Sarcopenia in Chilean Adults Following a Strength Training Program
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Physical Activity
Keywords: vegan diet
omnivorous diet
strength training
Lead sponsor: Universidad de Concepcion
Sponsor class: OTHER
First posted: 2024-05-21
Enrollment: 83
Sex: ALL
Minimum age (years): 18
Maximum age (years): 59
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The study consisted of a 4-arm non-randomized controlled clinical trial, with measurements at the beginning and end of a 16-week intervention.
Primary purpose: OTHER

Brief summary: 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.

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.

Eligibility criteria: 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).

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Primary outcomes:
measure: Body weight
timeFrame: 16 weeks of intervention
measure: waist circumference
timeFrame: 16 weeks of intervention
measure: fat mass
timeFrame: 16 weeks of intervention
measure: Lean mass
timeFrame: 16 weeks of intervention
measure: maximum strength
timeFrame: 16 weeks of intervention
measure: Manual grip strength
timeFrame: 16 weeks of intervention
measure: Vertical jump
timeFrame: 16 weeks of intervention
Secondary outcomes:
Other outcomes:
Locations:
city: Concepción
country: Chile
facility: Richar Carcamo Regla
state: Concepcion
Study officials:
affiliation: Universidad de Concepcion
name: Rafael E Zapata Lamana, Doctor
role: STUDY_DIRECTOR
References:
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citation: Reid-McCann RJ, Brennan SF, McKinley MC, McEvoy CT. The effect of animal versus plant protein on muscle mass, muscle strength, physical performance and sarcopenia in adults: protocol for a systematic review. Syst Rev. 2022 Apr 13;11(1):64. doi: 10.1186/s13643-022-01951-2.
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citation: Hannaian SJ, Churchward-Venne TA. Meatless Muscle Growth: Building Muscle Size and Strength on a Mycoprotein-Rich Vegan Diet. J Nutr. 2023 Jun;153(6):1665-1667. doi: 10.1016/j.tjnut.2023.04.011. Epub 2023 Apr 14. No abstract available.
citation: Pohl A, Schunemann F, Bersiner K, Gehlert S. The Impact of Vegan and Vegetarian Diets on Physical Performance and Molecular Signaling in Skeletal Muscle. Nutrients. 2021 Oct 29;13(11):3884. doi: 10.3390/nu13113884.