NCT05709639

Brief Summary

The Relative Energy Deficiency in Sport (RED-S) syndrome is common in high performance sports, and it impairs athletes' performance and health. The condition is caused by low energy availability (LEA). This means that the body does not have enough energy, after fuelling exercise, to support normal body functions. LEA weakens the structure of bone tissue and increases the risk of bone injuries, lowers your immune function, and increases risk of illnesses, lowers your metabolism, reduces reproductive hormones, and impairs muscle function. More people are investigating the use of nutrition education programs and individualized nutrition support to improve nutrition knowledge and eating habits in elite athletes. Because the results from available studies look promising, more professionals are examining the effectiveness of different nutrition intervention strategies to improve energy and nutrient intake in athletes. At this point, we do not know if athletes who have higher nutrition knowledge have better eating habits to lower the risk of LEA. Moreover, we do not know what nutrition interventions are useful to improve food intake in athletes who do not eat enough calories for exercise. With this study we hope to learn if individualized counselling in sport nutrition is associated with changes in eating habits and sport nutrition knowledge in elite athletes to enhance energy availability. It will also teach us if other factors are important to consider when relying on individualized sport nutrition counselling to lower the risk of LEA. Main Aim: Investigate the differences in individualized nutrition counselling characteristics, sport nutrition knowledge and self-reported body weight and shape concerns between high and low eating behaviour change responders among tier 4 and 5 elite athletes. Hypothesis: It is hypothesized that self-reported body weight and shape concerns will be negatively associated, and nutrition knowledge will be positively associated with changes in energy and carbohydrate intake in athletes receiving individualized nutrition counselling for 12 weeks.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2023

Geographic Reach
1 country

1 active site

Status
unknown

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

January 24, 2023

Completed
9 days until next milestone

First Posted

Study publicly available on registry

February 2, 2023

Completed
4 months until next milestone

Study Start

First participant enrolled

June 1, 2023

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2024

Completed
29 days until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2024

Completed
Last Updated

December 6, 2023

Status Verified

November 1, 2023

Enrollment Period

10 months

First QC Date

January 24, 2023

Last Update Submit

November 30, 2023

Conditions

Outcome Measures

Primary Outcomes (2)

  • Nutrition knowledge

    PEAK-NQ

    12 weeks

  • Change in carbohydrate intake

    Food Record

    12 weeks

Secondary Outcomes (1)

  • Change in food frequency intake of carbohydrate rich foods

    12 weeks

Study Arms (1)

Responder

EXPERIMENTAL

Increased carbohydrate intake (top 50%) vs moderate to regression in carbohydrate intake (lower 50%)

Other: Individualized counselling in nutrition

Interventions

Individualized counselling in nutrition - collaborate on a nutrition plan

Also known as: Nutrition Intervention
Responder

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Over 18 years of age
  • Active to participate in training and competition
  • Able-bodied sport program
  • Having given informed consent

You may not qualify if:

  • Eating Disorder Examination Questionnaire 6.0 total score \> 2.50 (women) and \> 1.68 (male)
  • Unable to understand spoken and written English

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

McGill University

Montreal, Quebec, H9X 3V9, Canada

RECRUITING

MeSH Terms

Conditions

Behavior

Interventions

Nutritional StatusDiet Therapy

Intervention Hierarchy (Ancestors)

Nutritional Physiological PhenomenaDiet, Food, and NutritionPhysiological PhenomenaHealth StatusDemographyPopulation CharacteristicsNutrition TherapyTherapeutics

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 24, 2023

First Posted

February 2, 2023

Study Start

June 1, 2023

Primary Completion

April 1, 2024

Study Completion

April 30, 2024

Last Updated

December 6, 2023

Record last verified: 2023-11

Locations