Recruiting

Effects of Dietary Supplements on Middle Aged Women's Health and Wellbeing

Study Aim

This study aims to evaluate the impact of dietary supplements on joint pain experienced by middle-aged women, under various conditions, using a 100 mm visual analogue scale (VAS) for measurement.

What is being tested

Daily Collagen and Omega-3 Supplement

+ Placebo Dietary Supplement Study

Dietary Supplement

Who is being recruted

Joint Diseases+5

+ Musculoskeletal Diseases

+ Neurologic Manifestations

From 35 to 65 Years

+16 Eligibility Criteria

See all eligibility criteria

How is the trial designed

Treatment Study

Placebo-Controlled

Interventional

Study Start: May 2026

See protocol details

Summary

Principal SponsorLoughborough University

Study ContactTom Clifford Dr CliffordMore contacts

Last updated: August 3, 2026

Sourced from a government-validated database.Claim as a partner

Study start date: May 1, 2026

Actual date on which the first participant was enrolled.

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.

NCT07740967

Principal SponsorLoughborough University

Study ContactTom Clifford Dr CliffordMore contacts

Last updated: August 3, 2026

Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

34 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.

Conditions

Criteria

Female

Biological sex of participants that are eligible to enroll.

From 35 to 65 Years

Range of ages for which participants are eligible to join.

Healthy volunteers allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Joint DiseasesMusculoskeletal DiseasesNeurologic ManifestationsPainSigns and SymptomsPathological Conditions, Signs and SymptomsFatigueArthralgia

Criteria

6 inclusion criteria required to participate

Age 35 - 65 years old

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))

Female

Show More Criteria

10 exclusion criteria prevent from participating

Allergy to ingredients in supplements or standardized breakfasts

Any known cognitive or visual impairments limiting ability to perform cognitive tests

BMI not between 18-30 kg/m2

Currently consuming the supplements being investigated and unwilling to stop taking them

Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.

Treatment Groups

Study Objectives

2 intervention groups are designated in this study

50% chance of being blinded to the placebo group

Treatment Groups

Group I

Experimental

Participants in this group receive a daily dose of collagen peptides and omega-3 supplements for 8 weeks. The collagen dose is approximately 10 grams per day and omega-3 is given as 2 capsules per day.

Group II

Placebo

Participants in this group will receive a maltodextrin supplement (~10 g/day) for 8 weeks. This is a placebo, meaning it looks like the real treatment but does not contain any active medication.

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Recruiting

Loughborough University

Loughborough, United KingdomOpen Loughborough University in Google Maps

Recruiting

One Study Center