Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 10:01 PM
Ignite Modification Date:
2025-12-24 @ 10:01 PM
NCT ID:
NCT07135232
Brief Summary:
The aim of this clinical trial is to determine if resistance training and a newly developed plant-based nutritional supplement can improve the symptoms and musculoskeletal health of perimenopausal women.
The main questions it aims to evaluate are:
1. Can resistance training and the nutritional supplement - both independently and in combination - improve perimenopausal symptoms (e.g. cognition, mood, sleep) and musculoskeletal outcomes (e.g. strength, muscle mass)?
2. What are the acute effects of the nutritional supplement on cognitive function and mood in perimenopausal women, and is this response altered following long-term intake (12 weeks)?
3. What mechanisms may be contributing to the results?
Participants will be split into four groups to allow the researchers to answer the above questions. These are:
1. The nutritional supplement + resistance training
2. The nutritional supplement only
3. The placebo supplement (A look alike capsule that contains no active ingredients) and resistance training
4. The Placebo supplement only.
Participants will:
* Take their allocated supplement daily and perform home-based strength exercise 3 times per week (for exercise groups), for 12 weeks.
* Attend the laboratory at the beginning and end of the 12 weeks to assess cognitive function and mood following acute intake of the supplement.
* Attend the laboratory every 4 weeks during the 12 week period, for assessment of cognitive function, symptom severity and muscle health.
* Provide a blood sample at each visit for assessment of mechanistic pathways.
Study:
NCT07135232
Study Brief:
Protocol Section:
NCT07135232