Dietary Supplements and Middle Aged Women (Creatine)

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age35-65
SponsorLoughborough University

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Female

Aged 35-65 years old

Healthy, free from known disease

Non-smoker

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Creatine Monohydrate

    Dietary supplement

    Creatine monohydrate for 8 weeks (\~6 g/day)

  • Placebo control

    Dietary supplement

    Maltodextrin for 8 weeks (\~10 g/day)

Treatment groups

38 Participants
are divided into 2 treatment groups
Group A: CreatineExperimental treatment 1 intervention
Group B: Placebo controlPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

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).

Time frame
8 weeks

Secondary outcomes

1

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

Time frame
8 weeks
2

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.

Time frame
8 weeks
3

Blood pressure (mmHg)

After 10 minutes of seated rest, 3 blood pressure readings will be taken and recorded using an automated cuff.

Time frame
8 weeks
4

Augmentation index

Augmentation index will be assessed using radial artery tonometry. Aortic Augmentation (AP, mmHg) and Aortic Augmentation Index (AP/PP, %) will be recorded.

Time frame
8 weeks

Other outcomes

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