NCT07729930

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
38

participants targeted

Target at P25-P50 for not_applicable

Timeline
28mo left

Started May 2026

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress10%
May 2026Nov 2028

Study Start

First participant enrolled

May 1, 2026

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

July 8, 2026

Completed
20 days until next milestone

First Posted

Study publicly available on registry

July 28, 2026

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2028

Last Updated

July 28, 2026

Status Verified

July 1, 2026

Enrollment Period

2.5 years

First QC Date

July 8, 2026

Last Update Submit

July 21, 2026

Conditions

CognitionMuscle StrengthFatigue SymptomSleepQuality of LifeInflammation BiomarkersBone Metabolism BiomarkersBlood Pressure and Augmentation IndexBody Composition ChangesGastrointestinal ComfortJoint PainMenopause Symptoms

Keywords

CreatineMiddle aged womenCognitive functionDietary supplements

Outcome Measures

Primary Outcomes (1)

  • Cognitive function

    Participants will complete 3 cognitive function tests on a laptop in a quiet room: the Letter Comparison test (measuring reaction time (ms) and accuracy (%)), the Backwards Digit Span test (measuring the longest correct span score), and the Stroop Colour Word test (measuring congruent/incongruent/neutral reaction time (ms) and accuracy (%), and the Interference Effect (calculated as incongruent reaction time - congruent reaction time).

    8 weeks

Secondary Outcomes (10)

  • Body composition measured using bioelectrical impedance analysis (BIA)

    8 weeks

  • Hand grip strength dynamometry (kg)

    8 weeks

  • Blood pressure (mmHg)

    8 weeks

  • Augmentation index

    8 weeks

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

    8 weeks

  • +5 more secondary outcomes

Study Arms (2)

Creatine

EXPERIMENTAL
Dietary Supplement: Creatine Monohydrate

Placebo control

PLACEBO COMPARATOR
Dietary Supplement: Placebo control

Interventions

Creatine MonohydrateDIETARY_SUPPLEMENT

Creatine monohydrate for 8 weeks (\~6 g/day)

Creatine
Placebo controlDIETARY_SUPPLEMENT

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

Placebo control

Eligibility Criteria

Age35 Years - 65 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsCisgender women
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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).

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Loughborough University

Loughborough, LE11 3TU, United Kingdom

RECRUITING

MeSH Terms

Conditions

FatigueArthralgia

Interventions

Creatine

Condition Hierarchy (Ancestors)

Signs and SymptomsPathological Conditions, Signs and SymptomsJoint DiseasesMusculoskeletal DiseasesPainNeurologic Manifestations

Intervention Hierarchy (Ancestors)

GuanidinesAmidinesOrganic ChemicalsAmino AcidsAmino Acids, Peptides, and Proteins

Central Study Contacts

Dr Tom Clifford

CONTACT

+44 (0) 1509228181t.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 in Exercise and Health Nutrition

Study Record Dates

First Submitted

July 8, 2026

First Posted

July 28, 2026

Study Start

May 1, 2026

Primary Completion (Estimated)

November 1, 2028

Study Completion (Estimated)

November 1, 2028

Last Updated

July 28, 2026

Record last verified: 2026-07

Data Sharing

IPD Sharing
Will not share

Locations

GB(1)