Dietary Supplements and Middle Aged Women (Creatine)

Официальное название

The Effects of Dietary Supplements on Health and Wellbeing in Middle Aged Women

Обзор

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.

Подробное описание

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.

Вмешательства

• Пищевая добавка Creatine Monohydrate
  Creatine monohydrate for 8 weeks (\~6 g/day)
• Пищевая добавка Placebo control
  Maltodextrin for 8 weeks (\~10 g/day)

Первичные конечные точки

• Cognitive function [Срок оценки: 8 weeks]

Вторичные конечные точки (10)

• Body composition measured using bioelectrical impedance analysis (BIA) [Срок оценки: 8 weeks]
• Hand grip strength dynamometry (kg) [Срок оценки: 8 weeks]
• Blood pressure (mmHg) [Срок оценки: 8 weeks]
• Augmentation index [Срок оценки: 8 weeks]
• Fatigue under 2 conditions measured by a 100 mm visual analogue scale (VAS) [Срок оценки: 8 weeks]
• Sleep quality measured by Athens Insomnia Scale and a simple Sleep Quality Scale [Срок оценки: 8 weeks]
• Quality of life assessed by the 36-Item Short Form Survey Instrument (SF-36) [Срок оценки: 8 weeks]
• Gastrointestinal comfort measure via a Likert Scale under 3 conditions [Срок оценки: 8 weeks]
• Menstrual cycle/menopause symptom questionnaire [Срок оценки: 8 weeks]
• Joint pain assessed via a 100mm visual analogue scale (VAS) [Срок оценки: 8 weeks]

Критерии участия

Критерии включения

• 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).

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Тройное слепое

Основная цель

Лечение

Центры проведения

Великобритания · 1 центр

• Loughborough University — Loughborough

Идентификаторы

NCT: NCT07729930 · 23225b

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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