NCT06444698

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
32

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 23, 2024

Completed
13 days until next milestone

First Posted

Study publicly available on registry

June 5, 2024

Completed
2 months until next milestone

Study Start

First participant enrolled

July 25, 2024

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 25, 2024

Completed
15 days until next milestone

Study Completion

Last participant's last visit for all outcomes

October 10, 2024

Completed
Last Updated

February 24, 2025

Status Verified

July 1, 2024

Enrollment Period

2 months

First QC Date

May 23, 2024

Last Update Submit

February 20, 2025

Conditions

Outcome Measures

Primary Outcomes (5)

  • strength of the biceps and triceps by Hand held dynameter

    base line measurement and post test after 4 weeks of intervention

  • Maximum oxygen uptake capacity (Vo2max) assessed by Queen's College Step Test (QCT)

    base line measurement and post test after 4 weeks of intervention

  • standing long jump test

    base line measurement and post test after 4 weeks of intervention

  • Ball throw test

    base line measurement and post test after 4 weeks of intervention

  • Agility T-test

    base line measurement and post test after 4 weeks of intervention

Study Arms (2)

Experimental group

EXPERIMENTAL

the experimental group will receive two cookies that contain 50 grams of quinoa

Dietary Supplement: cookies that contain 50 grams of quinoa

Control group

PLACEBO COMPARATOR

control group will receive the same two cookies that but without quinoa

Dietary Supplement: cookies without quinoa

Interventions

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.

Experimental group
cookies without quinoaDIETARY_SUPPLEMENT

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.

Control group

Eligibility Criteria

Age15 Years - 18 Years
Sexmale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Healthy adolescent male athletes aged 15 to 18

You may not qualify if:

  • Use any dietary supplementation, including protein powder, during the study period.
  • \. Musculoskeletal, neurological, cardiovascular, or systemic disorders which may affect the testing as reported by the participants
  • \. Biomechanical abnormalities which may affect the testing as reported by the participants
  • \. Participants psychological disorders
  • \. Participants on medication which may affect the measurements as reported by the participants
  • \. Allergic from any recipe ingredients

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Imam abdulrahman bin faisal university

Dammam, 34521, Saudi Arabia

Location

Study Officials

  • Shibili Nuhmani, PhD

    Imam Abdulrahman Bin Faisal University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

May 23, 2024

First Posted

June 5, 2024

Study Start

July 25, 2024

Primary Completion

September 25, 2024

Study Completion

October 10, 2024

Last Updated

February 24, 2025

Record last verified: 2024-07

Data Sharing

IPD Sharing
Will not share

Locations