Recruitment of volunteers and experimental design
AZUL, CREST, RECRUITMENT, BLIND
The “Novel Nutraceutical Supplement Trial” is a randomized controlled trial addressing sedentary people with three assessment points (baseline and 90 and 180 days post-supplementation) from Monte Azul Ambulatory, São Paulo, SP, Brazil, and online invitation between March and June 2021 (n = 133). Stratified randomization was applied to ensure a balance of baseline key factors between groups. In this study, age, BMI, and gender were considered baseline characteristics for sample stratification before randomization. The pharmaceutical team responsible for preparing the supplement capsules was the blind spot between participants and researchers until the end of the study. The sample size enrolled was based on a calculation determined using the G*Power software (The inclusion criteria were as follows: healthy volunteers of both genders aged between 44 and 64 years; BMI ≤34.9 kg/mPopulation physical activity level is classified by the International Physical Activity Questionnaire (IPAQ).HEPA active, health-enhancing physical activity.All volunteers signed a term of free and informed consent before starting the study and could withdraw the consent at any time. Therefore, volunteers were divided into two groups: Novel Nutraceutical Supplement_(S) (n = 30) and Novel Nutraceutical Supplement (n = 29). Volunteers were instructed to take two capsules of the supplements in the morning and two capsules in the evening. The participants were instructed to maintain their eating habits, and no nutritional intervention was performed during the study period.We used a Consolidated Standards of Reporting Trials (CONSORT) (Consolidated Standards of Reporting Trials (CONSORT) flowchart describing the recruitment of volunteers and the experimental design carried out on this clinical trial.Anthropometric and demographic characterization of the study population.BMI, body mass index; WC-mid, waist circumference in middle abdomen; WC-IC, waist circumference in iliac crest; WHtR, waist-to-height ratio; WHR, waist-to-hip ratio.Data values are expressed as mean ± SEM.



T0, day 0; T90, 90 days post-supplementation; T180, 180 days post-supplementation.