CognitionNCT07729930
Dietary Supplements and Middle Aged Women (Creatine)
A study testing Creatine Monohydrate in people with Cognition and Muscle Strength, run by Loughborough University at 1 site in United Kingdom.
Trial 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… Read more about this study
- Who is it for?
- Ages 35 to 65 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Cognition, Muscle Strength, Fatigue Symptom
- What is being tested?
- Creatine Monohydrate
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 38 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 May 2026to 1 Nov 2028
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 to 65 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United Kingdom1 site, 1 recruiting
- Recruiting
Loughborough University
Loughborough, LE11 3TU
Dr Tom Clifford, +44 (0) 1509228181, t.clifford@lboro.ac.uk
About this study
Official title: The Effects of Dietary Supplements on Health and Wellbeing in Middle Aged Women
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.
Read the 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.
- Conditions
- Cognition, Muscle Strength, Fatigue Symptom, Blood Pressure and Augmentation Index, Body Composition Changes, Sleep
- Being tested
- Creatine Monohydrate, Placebo control
- Keywords
- Creatine, Middle aged women, Cognitive function, Dietary supplements
- Medical subject headings
- Fatigue, Arthralgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Creatine MonohydrateDietary supplement
Creatine monohydrate for 8 weeks (~6 g/day)
Placebo controlDietary supplement
Maltodextrin for 8 weeks (~10 g/day)
| Study group | Role | What they receive |
|---|---|---|
| Creatine | Experimental | Not described Receives: Dietary Supplement: Creatine Monohydrate |
| Placebo control | Placebo comparator | Not described Receives: Dietary Supplement: Placebo control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cognitive function
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).
Measured: 8 weeks
Secondary outcomes (10)
Body composition measured using bioelectrical impedance analysis (BIA)
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
Measured: 8 weeks
Hand grip strength dynamometry (kg)
Hand grip strength will be assessed following the Southampton Protocol (Roberts et al., 2011), where 3 measures will be taken for each hand.
Measured: 8 weeks
Blood pressure (mmHg)
After 10 minutes of seated rest, 3 blood pressure readings will be taken and recorded using an automated cuff.
Measured: 8 weeks
Augmentation index
Augmentation index will be assessed using radial artery tonometry. Aortic Augmentation (AP, mmHg) and Aortic Augmentation Index (AP/PP, %) will be recorded.
Measured: 8 weeks
Fatigue under 2 conditions measured by a 100 mm visual analogue scale (VAS)
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).
Measured: 8 weeks
Sleep quality measured by Athens Insomnia Scale and a simple Sleep Quality Scale
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.
Measured: 8 weeks
Quality of life assessed by the 36-Item Short Form Survey Instrument (SF-36)
A total score will be calculated, with a higher score indicating a better quality of life
Measured: 8 weeks
Gastrointestinal comfort measure via a Likert Scale under 3 conditions
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.
Measured: 8 weeks
Menstrual cycle/menopause symptom questionnaire
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
Measured: 8 weeks
Joint pain assessed via a 100mm visual analogue scale (VAS)
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).
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2026
- Study start1 May 2026
- Primary completion1 Nov 2028 (estimated)
- Study completion1 Nov 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CognitionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 38 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Loughborough University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tom Clifford, Loughborough University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07729930
- Sponsor's protocol ID
- 23225b
- Status last verified
- Jul 2026
- First submitted
- 8 Jul 2026
- Last updated
- 28 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No