Dietary Supplements and Middle Aged Women (Collagen & Omega)

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 collagen (\~10 g/day) and omega-3 (2 capsules/day) or maltodextrin (\~10 g/day) and 2 empty capsules 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 measures 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 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 Collagen peptides and omega-3
  Collagen peptides daily for 8 weeks (\~10 g/day) Omega-3 supplement daily for 8 weeks (2 capsules/day)
• Dietary supplement Placebo control
  Maltodextrin (\~10 g/day) for 8 weeks

Primary outcome measures

• Joint pain under 3 conditions as measured by a 100 mm visual analogue scale (VAS) [Time frame: 8 weeks]

Secondary outcome measures (12)

• Hand grip strength dynamometry (kg) [Time frame: 8 weeks]
• Blood pressure (mmHg) [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 an Athens Insomnia Scale [Time frame: 8 weeks]
• Simple Sleep Quality Scale [Time frame: 8 weeks]
• Aortic Augmentation (AP, mmHg) [Time frame: 8 weeks]
• Aortic Augmentation Index (AP/PP, %) [Time frame: 8 weeks]
• Letter Comparison test of cognitive function [Time frame: 8 weeks]
• Backwards Digit Span test of cognitive function [Time frame: 8 weeks]
• Stroop Colour Word test of cognitive function [Time frame: 8 weeks]
• Stroop Colour Word test of cognitive function [Time frame: 8 weeks]
• Quality of life assessed by the 36-Item Short Form Survey Instrument (SF-36) [Time frame: 8 weeks]

Eligibility criteria

Inclusion criteria

• Female
• Age 35 - 65 years old
• Healthy, free from known disease
• Non-smoker
• BMI of 18 - 30 kg/m2 of
• Classified as either recreationally physically active (meet the WHO guidelines for physical activity of completing at least 150-300 min moderate-intensity activity or 75-150 min of vigorous-intensity activity a week, plus muscle-strengthening activities 2 or more days a week) OR classified as sedentary (do not meet 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 (e.g., cardiovascular disease, 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 and/or currently unstable
• BMI not between 18-30 kg/m2
• Allergy to ingredients in supplements or standardized breakfasts
• Pregnant or breastfeeding, or any other contraindications to consuming study supplements
• Lost more than 10% of body mass in past 6 months or plan on trying to lose body mass during trial period
• Currently consuming the supplements being investigated and unwilling to stop taking them
• Any known cognitive or visual impairments limiting ability to perform cognitive tests
• Unwilling to maintain current diet and physical activity levels or exercise and activity levels above recreationally active (e.g., athlete)

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: NCT07740967 · 23225

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗