Dietary Supplements and Middle Aged Women (Collagen & Omega)

NCT07740967 | Recruiting

• 1 other identifier: 23225
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Cognition; Fatigue Symptom; Sleep; Joint Pain; Quality of Life; Gastrointestinal Comfort; Blood Pressure and Augmentation Index; Muscle Strength; Fatty Acid Blood Profile; Inflammation Biomarkers; Body Composition Changes; Bone Metabolism Biomarkers

Keywords

Collagen peptides; Middle aged women; Joint pain; Dietary supplements

Outcome Measures

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).

  8 weeks

Secondary Outcomes (22)

• Hand grip strength dynamometry (kg)

  8 weeks

• Blood pressure (mmHg)

  8 weeks

• Fatigue under 2 conditions measured by a 100 mm visual analogue scale (VAS)

  8 weeks

• Sleep quality measured by an Athens Insomnia Scale

  8 weeks

• Simple Sleep Quality Scale

  8 weeks

Study Arms (2)

Collagen and Omega-3

EXPERIMENTAL

Dietary Supplement: Collagen peptides and omega-3

Placebo control

PLACEBO COMPARATOR

Dietary Supplement: Placebo control

Interventions

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)

Collagen and Omega-3

Placebo control DIETARY_SUPPLEMENT

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

Placebo control

Eligibility Criteria

• Age: 35 Years - 65 Years
• Gender Eligibility Details: Cisgender women
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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))

You may not qualify if:

• 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)

Sponsors & Collaborators

• Loughborough University: lead

Study Sites (1)

Loughborough University

Loughborough, LE11 3TU, United Kingdom

RECRUITING

MeSH Terms

Conditions

Fatigue; Arthralgia

Interventions

Docosahexaenoic Acids

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Joint Diseases; Musculoskeletal Diseases; Pain; Neurologic Manifestations

Intervention Hierarchy (Ancestors)

Fatty Acids, Omega-3; Dietary Fats, Unsaturated; Dietary Fats; Fats; Lipids; Fatty Acids, Unsaturated; Fatty Acids; Fish Oils; Oils

Central Study Contacts

Tom Clifford Dr Clifford

CONTACT

+44 (0) 1509 228181; t.clifford@lboro.ac.uk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Reader (Associate Professor) in Exercise and Health Nutrition, Principal Investigator

Study Record Dates

• First Submitted: July 8, 2026
• First Posted: August 3, 2026
• Study Start: May 1, 2026
• Primary Completion (Estimated): August 1, 2028
• Study Completion (Estimated): August 1, 2028
• Last Updated: August 3, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)