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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06444698
Other study ID # IRB-PGS-2023-03-340
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date June 5, 2024
Est. completion date September 10, 2024

Study information

Verified date May 2024
Source Imam Abdulrahman Bin Faisal University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Background: Proper nutrition is essential for sports performance. Quinoa is a gluten-free grain rich in macronutrients such as protein, polysaccharides, and fatty acids and consists of many phytochemicals such as carotenoids, flavonoids, saponins, fiber, vitamins, and minerals. Phytochemicals in quinoa act as antioxidant and anti-inflammatory. This will protect against several oxidative stress related diseases. Objective: Investigate the effect of 50 g of quinoa for four weeks on muscle strength, VO2max and athletic performance among adolescent athletes. Study design: A Double blinded randomized control trial with pre-test and post-test design. Methods :32 subjects will be included in this trial. Subjects will be divided randomly into control and experimental group with a 1:1 ratio; the experimental group will receive two cookies that contain 50 grams of quinoa; the control group will receive the same two cookies that but without quinoa. Strength will be assessed by using hand-held dynamometer (HHD). Maximum oxygen uptake capacity (Vo2max) will be assessed by Queen's College step test (QCT). And for evaluating performance: standing long jump test, ball throw test, and agility T-test will be used. Subjects will be asked to take the cookies 1-4 hours before bedtime daily during the study period. Statistical Analysis: Shapiro wilk test will be performed to check the normality of the data and Levenes test will be performed to check homogeneity of variance. Cohen's d will be used to check the effect size. The level of significance is set to p ≤ 0.05.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 32
Est. completion date September 10, 2024
Est. primary completion date August 5, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Male
Age group 15 Years to 18 Years
Eligibility Inclusion criteria: 1- Healthy adolescent male athletes aged 15 to 18 Exclusion criteria: 1- Use any dietary supplementation, including protein powder, during the study period. 2. Musculoskeletal, neurological, cardiovascular, or systemic disorders which may affect the testing as reported by the participants 3. Biomechanical abnormalities which may affect the testing as reported by the participants 4. Participants psychological disorders 5. Participants on medication which may affect the measurements as reported by the participants 6. Allergic from any recipe ingredients

Study Design


Related Conditions & MeSH terms


Intervention

Dietary Supplement:
cookies that contain 50 grams of quinoa
250 grams of ground quinoa will be mixed with 250 grams of ready-to-use cookie flour and 100 gram of butter, one egg, and 75 gram of chocolate chips will be added. After mixing, the ingredients will be divided into (10) cookies (each cookie will continue 25 grams of quinoa) and bake them in oven for 9-11 mint at 190 °C. The placebo control group will receive cookies that continue the same ingredient but without quinoa and the cookies will look like the experimental group cookies. Cookies delivery will be every 3 to 4 days for each participants.
cookies without quinoa
The placebo control group will receive cookies that continue the same ingredient of experimental group but without quinoa and the cookies will look like the experimental group cookies.

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Imam Abdulrahman Bin Faisal University

Outcome

Type Measure Description Time frame Safety issue
Primary strength of the biceps and triceps by Hand held dynameter base line measurement and post test after 4 weeks of intervention
Primary Maximum oxygen uptake capacity (Vo2max) assessed by Queen's College Step Test (QCT) base line measurement and post test after 4 weeks of intervention
Primary standing long jump test base line measurement and post test after 4 weeks of intervention
Primary Ball throw test base line measurement and post test after 4 weeks of intervention
Primary Agility T-test base line measurement and post test after 4 weeks of intervention
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