Creatine supplementation on markers of health and cognitive function in older adults Other
Conditions
Interventions
Participants will be randomized (using Stratified Randomization using sealed envelopes) into one of four treatment groups :
1. No Exercise + Placebo (2 x 5 g/d of dextrose)
2. No Exercise + Creatine
Sponsors
WoodNext Foundation
Eligibility
Sex/Gender
All
Age
45 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. Male or female between the ages of 45 and 65 years 2. Participant has the ability to comply with the study procedures 3. Participant agrees to refrain from alcohol intake and the use of non-steroidal anti-inflammatory drugs (NSAIDS), aspirin, and other over-the counter pain medications for 48-hours prior to each testing session 4. Participant has the availability to complete the study based on the duration of the individual study visits and scheduling requirements
Exclusion criteria
Exclusion criteria: 1. Participant is pregnant, breastfeeding, or wishes to become pregnant during the study 2. Participant has an orthopedic limitation that would prevent participation in the study 3. Participant has taken weight loss dietary supplements or medications during the last 2 weeks 4. Participant has a history within the previous 12 months of alcohol or substance abuse 5. Participant is a heavy smoker (>1 pack/day within the past 3 months) 6. Participant has a known allergy to creatine or dextrose
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Body weight measured using a calibrated, digital scale at 0, 6, 12 weeks 2. Body fat mass (kg) measured using dual-energy x-ray absorptiometry (DXA) at 0, 6, 12 weeks 3. Body composition (%) measured using DXA at 0, 6, 12 weeks 4. Waist to hip circumference (W/H) measured using a tension-regulated tape measure at 0, 6, 12 weeks - 5. Subjective memory complaints measured using the Memory Complaint Questionnaire (MAC-Q) at 0, 6, 12 weeks 6. Various aspects of memory and learning measured using the Wechsler Memory Scale (WMS - VAP1 and VAP2) at 0, 6, 12 weeks 7. A range of cognitive skills including processing speed, memory, attention, executive function, and visuoperceptual skills measured using the COMPASS Cognitive Function Test Battery at 0, 6, 12 weeks 8. Various aspects of mental function measured using the Mini-Mental State Examination (MMSE) at 0, 6, 12 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Resting Energy Expenditure (REE) measured using a calibrated ParvoMedics TrueOne 2400 metabolic cart at 0, 6, 12 weeks 2. Graded Exercise Test (GXT - VO2 max) measured using a calibrated ParvoMedics TrueOne 2400 metabolic cart at 0, 6, 12 weeks 3. Muscular strength measured using bench press One-Repetition Maximum (1 RM) at 0, 6, 12 weeks 4. Muscular strength measured using leg press One-Repetition Maximum (1 RM) at 0, 6, 12 weeks 5. Muscular endurance measured using bench press muscular endurance (total work - total repetitions at 70% 1 RM) at 0, 6, 12 weeks 6. Muscular endurance measured using leg press muscular endurance (total work - total repetitions at 70% 1 RM) at 0, 6, 12 weeks 7. Complete Blood Count (CBC) measured using automated analyzers from Clinical Pathology Laboratories (CPL) at 0, 6, 12 weeks 8. Blood Chemistry Panel (Chem Panel) measured using automated analyzers from Clinical Pathology Laboratories (CPL) at 0, 6, 12 weeks 9. Blood Lipids (Lipid Panel) measured using automated analyzers from Clinical Pathology Laboratories (CPL) at 0, 6, 12 weeks 10. Hemoglobin A1c (HbA1c) measured using automated analyzers from Clinical Pathology Laboratories (CPL) at 0, 6, 12 weeks 11. An individual's overall well-being, encompassing their physical health, psychological state, and social relationships measured using the Quality of Life Questionnaire (SF-36) at 0, 6, 12 weeks 12. Physical activity and inactivity in adults over the past 7 days measured using the International Physical Activity Questionnaire (IPAQ) at 0, 6, 12 weeks 13. Fluctuations in six mood states (Tension-Anxiety, Depression-Dejection, Anger-Hostility, Vigor-Activity, Fatigue-Inertia, Confusion-Bewilderment) measured using the Profile of Mood States (POMS) Questionnaire at 0, 6, 12 weeks 12. Adverse effects assessed using Side-Effects Assessment at 0, 6, 12 weeks | — |
Countries
United States of America
Contacts
Public ContactChristopher Rasmussen
Outcome results
None listed