Dietary Supplements and Middle Aged Women (Collagen & Omega)

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

Age 35 - 65 years old

Healthy, free from known disease

Non-smoker

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Collagen peptides and omega-3

    Dietary supplement

    Collagen peptides daily for 8 weeks (\~10 g/day) Omega-3 supplement daily for 8 weeks (2 capsules/day)

  • Placebo control

    Dietary supplement

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

Treatment groups

34 Participants
are divided into 2 treatment groups
Group A: Collagen and Omega-3Experimental treatment 1 intervention
Group B: Placebo controlPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Joint pain under 3 conditions as measured by a 100 mm visual analogue scale (VAS)

Participants will place a vertical line on the VAS (ranging from no pain (0 mm) to unbearable pain (100 mm)) which will be measured and recorded. Participants will complete a separate VAS for each of the 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).

Time frame
8 weeks

Secondary outcomes

1

Hand grip strength dynamometry (kg)

Hand grip strength will be assessed following the Southampton Protocol, where 3 measures will be taken for each hand.

Time frame
8 weeks
2

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
3

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).

Time frame
8 weeks
4

Sleep quality measured by an Athens Insomnia 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.

Time frame
8 weeks

Other outcomes

Sponsors and contacts

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