Ignite Creation Date:
2024-06-16 @ 11:47 AM
Last Modification Date:
2024-10-26 @ 3:30 PM
Study NCT ID:
NCT06423209
Status:
COMPLETED
Last Update Posted:
2024-05-21
First Post:
2024-05-15
Brief Title:
Efficacy of a Training Program in Adults Following a Vegan Diet Versus an Omnivorous Diet
Sponsor:
Universidad de Concepcion
Organization:
Universidad de Concepcion
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
Vegan
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
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 Kgm2 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
The evaluation of nutritional status was carried out using the body mass index BMI Kgm2 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None