Effects of exercise, diet and creatine supplementation in middle-aged and older adults
| ISRCTN | ISRCTN83081058 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN83081058 |
| ClinicalTrials.gov (NCT) | Nil known |
| Clinical Trials Information System (CTIS) | Nil known |
| Protocol serial number | STUDY2024-0233 |
| Sponsor | WoodNext Foundation |
| Funder | WoodNext Foundation |
- Submission date
- 04/11/2025
- Registration date
- 06/11/2025
- Last edited
- 06/11/2025
- Recruitment status
- Recruiting
- Overall study status
- Ongoing
- Condition category
- Other
Plain English summary of protocol
Background and study aims
Research has identified four basic ways exercise, diet, and/or ingesting nootropic nutrients may affect cognitive function. First, acute exercise and exercise training increases blood flow and oxygen delivery to the brain, improving cognitive function. Second, increasing energy availability in the brain helps maintain energy availability during stress, fatigue, and injury, improving cognitive function. Third, reducing inflammation and/or oxidative stress in the brain can help improve recovery from ischemia or concussion and may play a role in slowing cognitive impairment as we age. Finally, stimulating neural activity in the brain can improve focus, memory, and delay mental fatigue. For this reason, most nootropic foods, beverages, and dietary supplements designed to improve cognitive function contain nutrients that can improve cerebral blood flow, energy availability in the brain, reduce inflammation and oxidative stress, or contain various stimulants. While there are data supporting the safety and effectiveness of some nootropic nutrients, more research is needed to explore the potential benefits of ingesting nootropic nutrients when combined with exercise, diet, and/or other nutrients. Additionally, more research is needed to examine how the effects of nootropic nutrients may change as we age and/or in people experiencing mild cognitive impairment. Therefore, the aim of this study is to determine if creatine supplementation helps to improve health, fitness, cognitive function, and quality of life in late middle-aged and older adults.
Who can participate?
Healthy volunteers between the ages of 45 and 65 years
What does the study involve?
Each participant will be asked to visit the lab four times over approximately a 12-week period. Each study visit will last about 2 to 3 hours (minus the first study visit or Familiarization which will last approximately 1 hour). Each visit after the first Familiarization visit will include; anthropometric measures (height, weight, W/H assessment), vital signs (heart rate and blood pressure), blood draw, DXA scan, resting energy expenditure test, muscular strength assessment, muscular endurance assessment, graded exercise test, food log assessment, physical activity questionnaire, quality of life questionnaire, profile of mood states questionnaire, memory complaint questionnaire, Wechsler Memory Scale questionnaire, Mini-Mental State Examination, COMPASS cognitive test battery, and side-effects assessment.
What are the possible benefits and risks of participating?
Possible benefits of participation include increased insight into one's health and fitness status (i.e., anthropometric measurements, vital sign measurements, lab values, DXA body composition and bone density values, etc). Possible risks of participation include complications from the blood draws (i.e., pain, dizziness, nausea, etc.), radiation exposure from the DXA scan (i.e., < 1 mRem per scan), side effects of the supplements (i.e., bloating, cramping, diarrhea, etc), and possible allergic reactions to the supplements.
Where is the study run from?
The study will be run from the Exercise & Sport Nutrition Laboratory (ESNL) at Texas A&M University (USA)
When is the study starting and how long is it expected to run for?
November 2023 to November 2026
Who is funding the study?
WoodNext Foundation (USA)
Who is the main contact?
Dr Richard Kreider, rbkreider@tamu.edu
Contact information
Scientific, Principal investigator
675 John Kimbrough Blvd
#118
College Station
77843-4253
United States of America
 ORCID ID |
0000-0002-3906-1658 |
|---|---|
| Phone | +1 (0)9794581498 |
| rbkreider@tamu.edu |
Public
675 John Kimbrough Blvd
Suite #206
College Station
77843-4253
United States of America
| ORCID ID |
0009-0005-8941-3067 |
|---|---|
| Phone | +1 (0)9794581741 |
| crasmussen@tamu.edu |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomized double-blind placebo-controlled clinical trial |
| Secondary study design | Randomised controlled trial |
| Study type | Participant information sheet |
| Scientific title | Effects of exercise, diet, and creatine supplementation on cognition and health in middle-aged and older adults |
| Study objectives | The objective of this study is to evaluate the effects of 12 weeks of creatine supplementation during an exercise and diet intervention on markers of health and cognitive function in older adults. |
| Ethics approval(s) |
Approved 10/06/2024, Texas A&M University Institutional Review Board (IRB) (301 Old Main Drive, Suite 3104, College Station, 77843, United States of America; +1 (0)9798458585; irb@tamu.edu), ref: STUDY2024-0233 |
| Health condition(s) or problem(s) studied | Creatine supplementation on markers of health and cognitive function in older adults |
| Intervention | 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 (2 x 5 g/d of creatine monohydrate) 3. Exercise + Placebo (2 x 5 g/d of dextrose) 4. Exercise + Creatine (2 x 5 g/d of creatine monohydrate) The supplements will be prepared in powder form in generic, labeled capsules from the sponsor. Participants will be asked to consume two doses of their assigned supplement per day (one with breakfast and one with dinner) for 12 weeks. |
| Intervention type | Supplement |
| Primary outcome measure(s) |
1. Body weight measured using a calibrated, digital scale at 0, 6, 12 weeks |
| Key secondary outcome measure(s) |
1. Resting Energy Expenditure (REE) measured using a calibrated ParvoMedics TrueOne 2400 metabolic cart at 0, 6, 12 weeks |
| Completion date | 20/11/2026 |
Eligibility
| Participant type(s) | Healthy volunteer |
|---|---|
| Age group | Adult |
| Lower age limit | 45 Years |
| Upper age limit | 65 Years |
| Sex | All |
| Target sample size at registration | 100 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 10/07/2024 |
| Date of final enrolment | 10/07/2026 |
Locations
Countries of recruitment
- United States of America
Study participating centre
Suite #206
College Station
77843-4253
United States of America
Results and Publications
| Individual participant data (IPD) Intention to share | Yes |
|---|---|
| IPD sharing plan summary | Available on request |
| IPD sharing plan | The datasets generated during and/or analyzed during the current study will be available upon request from Dr Richard Kreider (rbkreider@tamu.edu). |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
06/11/2025: Study's existence confirmed by the Texas A&M University Institutional Review Board (IRB).
