Blood Pressure and Augmentation Index, Body Composition Changes, Bone Metabolism Biomarkers, Cognition, Fatigue Symptom, Gastrointestinal Comfort, Inflammation Biomarkers, Joint Pain, Menopause Symptoms, Muscle Strength, Quality of Life, Sleep
Conditions
Keywords
Creatine, Middle aged women, Cognitive function, Dietary supplements
Brief summary
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_SUPPLEMENTCreatine Monohydrate
Creatine monohydrate for 8 weeks (\~6 g/day)
DIETARY_SUPPLEMENTPlacebo control
Maltodextrin for 8 weeks (\~10 g/day)
Sponsors
Loughborough University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
35 Years to 65 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cognitive function | 8 weeks | Participants will complete 3 cognitive function tests on a laptop in a quiet room: the Letter Comparison test (measuring reaction time (ms) and accuracy (%)), the Backwards Digit Span test (measuring the longest correct span score), and the Stroop Colour Word test (measuring congruent/incongruent/neutral reaction time (ms) and accuracy (%), and the Interference Effect (calculated as incongruent reaction time - congruent reaction time). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Body composition measured using bioelectrical impedance analysis (BIA) | 8 weeks | The following body composition measures will be taken: body mass (kg), fat mass (kg), calculated fat percentage (%), fat free mass (kg), body mass index (kg/m2, calculated as body mass divided by height squared), total body water (L), calculated total body water percentage |
| Hand grip strength dynamometry (kg) | 8 weeks | Hand grip strength will be assessed following the Southampton Protocol (Roberts et al., 2011), where 3 measures will be taken for each hand. |
| Blood pressure (mmHg) | 8 weeks | After 10 minutes of seated rest, 3 blood pressure readings will be taken and recorded using an automated cuff. |
| Augmentation index | 8 weeks | Augmentation index will be assessed using radial artery tonometry. Aortic Augmentation (AP, mmHg) and Aortic Augmentation Index (AP/PP, %) will be recorded. |
| Fatigue under 2 conditions measured by a 100 mm visual analogue scale (VAS) | 8 weeks | Participants will place a vertical line on the scale (ranging from no fatigue at all (0 mm) to extremely fatigued (100 mm)) which will be measured and recorded. Participants will complete a visual analogue scale for 2 conditions: right now, and during daily activities in the last week (such as walking, getting up from chairs, exercising). |
| Sleep quality measured by Athens Insomnia Scale and a simple Sleep Quality Scale | 8 weeks | The Athens Insomnia Scale is an 8-point questionnaire where participants rank different aspects of their sleep (sleep induction, awakenings during the night, final awakening, total sleep duration, overall sleep quality, sense of wellbeing during the day, functioning during the day, and sleepiness during the day) provided that it occurred at least 3 times in the last week from 0 (no issue) to 3 (serious issue). A lower total score indicates better sleep. |
| Quality of life assessed by the 36-Item Short Form Survey Instrument (SF-36) | 8 weeks | A total score will be calculated, with a higher score indicating a better quality of life |
| Gastrointestinal comfort measure via a Likert Scale under 3 conditions | 8 weeks | Participants select one option on the Likert scale ranging from 1 (no GI discomfort) to 4 (lots/frequent/extreme GI discomfort). There is a Likert Scale for each of the following conditions: GI discomfort right now, GI discomfort frequency in the last 8 weeks, and GI discomfort severity in the last 8 weeks. |
| Menstrual cycle/menopause symptom questionnaire | 8 weeks | The questionnaire assesses 12 common menstrual cycle/menopause symptoms. Participants rate the severity (0 = none, to 3 = severe) and frequency (0 = never, to 3 = often) of these symptoms. A higher score indicates worse menstrual cycle/menopause symptoms |
| Joint pain assessed via a 100mm visual analogue scale (VAS) | 8 weeks | Participants will place a vertical line on the scale (ranging from no pain (0 mm) to unbearable pain (100 mm)) which will be measured and recorded. Participants will complete a visual analogue scale for 3 conditions: after standing rest, after 5 body weight squats, and in response to pain levels during daily activities in the last week (such as walking, getting up from chairs, exercising). |
Countries
United Kingdom
Contacts
CONTACTDr Tom Clifford
Outcome results
None listed