Dietary Supplements and Middle Aged Women (Creatine)
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Creatine Monohydrate, Placebo control.
- Who it may be relevant to
- Registry conditions: Cognition, Muscle Strength, Fatigue Symptom, Blood Pressure and Augmentation Index. Basic parameters: 35 years — 65 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United Kingdom
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
The Effects of Dietary Supplements on Health and Wellbeing in Middle Aged Women
Overview
This study will examine the effects of combining different types of dietary supplements on various aspects of health and wellbeing in middle aged women. The main outcomes of the trial will be aspects of health and wellbeing that middle aged women report as increasingly problematic, such as joint pain, fatigue, sleep, and changes in body composition, strength, and inflammation. Participants will consume the supplement(s) or placebo for 8 weeks, and outcome measures will be assessed before and after supplementation.
Detailed description
Participants will be randomised to receive either creatine or maltodextrin to be taken daily for 8 weeks. Participants will first attend a familiarisation visit where consent will be given and cognitive function tests will be practised (letter comparison, backwards digit span test, and stroop color word tests). Participants will complete a 3-day food record diary before attending Visit 2. In Visit 2, participants will complete a range of questionnaires assessing physical activity, quality of life, sleep, menstrual cycle/menopause status and symptoms. Stature and body composition will be recorded. Blood pressure, augmentation index, and handgrip strength will be measured. Venous blood samples will be collected for later measures of inflammation, joint health, and fatty acid blood profile. Joint pain (under 3 conditions) and fatigue will be assessed using a 100mm Visual Analogue Scale. Gastrointestinal comfort will be rated using a Likert scale. Participants will be provided with another food record diary to complete 3 days prior to visit 3, and they will be given their supplements to consume for 8 weeks and a supplement log to track intake of supplements/medication. Visit 3 will occur 8 weeks after Visit 2 and it will follow the same format as Visit 2. Statistical analysis will be performed with linear mixed model and independent t-tests. Sample sizes are based on a prior estimations for these methods of analysis.
Interventions
- Dietary supplement Creatine Monohydrate
Creatine monohydrate for 8 weeks (\~6 g/day) - Dietary supplement Placebo control
Maltodextrin for 8 weeks (\~10 g/day)
Primary outcome measures
- Cognitive function [Time frame: 8 weeks]
Secondary outcome measures (10)
- Body composition measured using bioelectrical impedance analysis (BIA) [Time frame: 8 weeks]
- Hand grip strength dynamometry (kg) [Time frame: 8 weeks]
- Blood pressure (mmHg) [Time frame: 8 weeks]
- Augmentation index [Time frame: 8 weeks]
- Fatigue under 2 conditions measured by a 100 mm visual analogue scale (VAS) [Time frame: 8 weeks]
- Sleep quality measured by Athens Insomnia Scale and a simple Sleep Quality Scale [Time frame: 8 weeks]
- Quality of life assessed by the 36-Item Short Form Survey Instrument (SF-36) [Time frame: 8 weeks]
- Gastrointestinal comfort measure via a Likert Scale under 3 conditions [Time frame: 8 weeks]
- Menstrual cycle/menopause symptom questionnaire [Time frame: 8 weeks]
- Joint pain assessed via a 100mm visual analogue scale (VAS) [Time frame: 8 weeks]
Eligibility criteria
Inclusion criteria
- Female
- Aged 35-65 years old
- Healthy, free from known disease
- Non-smoker
- BMI 18-30 kg/m2
- Classified as recreationally active (meet the WHO guidelines for physical activity: complete at least 150-300 minutes of moderate intensity activity or 75-150 minutes of vigorous intensity activity a week, plus muscle strengthening activities 2 or more days a week) OR sedentary (do not meet the minimum activity guidelines but do occasional and/or incidental physical activity, e.g., walking to work, household activities).
Exclusion criteria
- Currently have a musculoskeletal injury or diagnosed condition (CVD, osteoarthritis, diabetes, cancer, metabolic syndrome, uncontrolled hypertension, gastrointestinal disease, blood clotting disorder)
- Regularly taking prescription medication initiated in the last 3 months or unstable
- Have initiated hormone replacement therapy within the last 3 months or unstable
- Have an allergy to ingredients in the supplements or standardised breakfast
- Pregnant or breastfeeding, or any other contradictions to consuming the study supplements
- Lost more than 10% of body mass in the past 6 months or plan on trying to lose body mass during trial period
- Currently consuming the supplements being investigated and unwilling to stop
- Any known cognitive or visual impairments limiting ability to perform cognitive tests
- Unwilling to maintain current diet and physical activity levels and report any change in health status
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Triple blind
- Primary purpose
- Treatment
Study locations
United Kingdom · 1 center
- Loughborough University — Loughborough
Identifiers
NCT: NCT07729930 · 23225b