Improving physical fitness and cognition with a nutritional intervention
| ISRCTN | ISRCTN96342002 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN96342002 |
| Secondary identifying numbers | ANGC1402 |
- Submission date
- 22/07/2020
- Registration date
- 28/07/2020
- Last edited
- 18/08/2023
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Nutritional, Metabolic, Endocrine
Plain English Summary
Background and study aims
This study aims to enhance and optimize human fitness and cognitive performance in Air Force airmen through a multimodal physical fitness and nutritional supplement intervention.
Who can participate?
Active Air Force airmen, healthy men and women aged 18-45
What does the study involve?
Participants will receive either a nutritional supplement plus physical fitness training or a placebo (dummy supplement) plus physical fitness training. Fitness measures, cognitive outcomes and blood samples will be collected before and after the intervention (after 12 weeks).
What are the possible benefits and risks of participating?
Benefits include enhanced physical fitness and improved cognitive functioning. Risks are minimal and, for the fitness intervention include normal risks due to strength and resistance training and the supplement is not believed to entail risks as it only includes over the counter supplements that do not exceed recommended daily allowances and that have science-backed evidence for their safety and improving health and/or cognition.
Where is the study run from?
The Air Force Research Lab, the 711th Human Performance Wing, in Dayton, OH (USA)
When is the study starting and how long is it expected to run for?
March 2015 to August 2018
Who is funding the study?
Abbott Nutrition, through the Center for Nutrition, Learning and Memory at the University of Illinois who sponsored the project
Who is the main contact?
Aron Barbey
barbey@illinois.edu
Contact information
Scientific
2165 Beckman Institute
405 North Mathews Avenue
Urbana
61801
United States of America
 ORCID ID |
0000-0002-6092-0912 |
|---|---|
| Phone | +1 (0)217 244 2551 |
| barbey@illinois.edu |
Public
2165 Beckman Institute
405 North Mathews Avenue
Urbana
61801
United States of America
| ORCID ID |
0000-0002-6092-0912 |
|---|---|
| Phone | +1 (0)217 244 2551 |
| barbey@illinois.edu |
Study information
| Study design | Single-center interventional double-blinded randomized controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Other |
| Study type | Other |
| Participant information sheet | Not applicable (study is already completed) |
| Scientific title | Enhanced physical and cognitive performance in active duty airmen: evidence from a randomized multimodal physical fitness and nutritional intervention |
| Study hypothesis | A multi-modal nutritional beverage plus physical fitness training will improve cognitive and fitness more than a placebo beverage paired with physical fitness training. |
| Ethics approval(s) | Approved 01/10/2015, Department of the Air Force, Air Force Research Laboratory, Wright-Patterson Air Force Base Institutional Review Board (1864 4th St, Wright-Patterson AFB, OH 45433, USA; +1 (0)937 656 5437; alex.trigo.2@us.af.mil); ref: FWR20150132H |
| Condition | Optimization of human performance in United States Air Force airmen |
| Intervention | The intervention is a two-arm trial, with one group receiving a nutritional beverage and physical fitness intervention and the other group receiving a placebo beverage and the same physical fitness intervention. Participants are block randomized across seven blocks of the study (each block has about 25 participants), with blocks alternating between the nutritional and placebo beverages. The intervention lasts 12 weeks. Beverages are liquid, 8-ounce bottles manufactured by Abbott Nutrition (Columbus, OH) and participants consume two beverages each day for 12 weeks. The exercise intervention occurs in the lab 5 days a week and includes strength, endurance, aerobic and interval training and all participants are guided in proper form and observed by athletic trainers. |
| Intervention type | Supplement |
| Primary outcome measure | Primary fitness measures, all measured at both pre- and post-intervention (12 weeks): R/L means an average of both the Right and Left side of the body 1. Abdominal circumference (inches), measured using a tape measure 2. Sled Push & Pull R/L (seconds) measured by pushing (15 yds) and pulling (15 yds) a 140 lb sled twice 3. Rotation Smash Ball R/L (inches), measured distance thrown of a heavy medicine ball 4. Weight (pounds), measured with a scale 5. Wingate Upper Body (Watts/kg) measured using an arm crank with fixed resistance for 30 seconds 6. Body fat (% body weight) measured using DEXA overall and segmented body composition 7. Modified Illinois Agility (seconds) measured by quickly completing a weaving running course 8. Pull-ups (1 minute to complete as many as possible) 9. Push-ups (1 minute to complete as many as possible) 10. Sit-ups (1 minute to complete as many as possible) 11. Standing long jump (inches), best of three jumps from a 2-foot static position 12. VO2 Max (mL/kg/min), oxygen consumption measured on treadmill 13. Wingate Lower Body (Watts/kg), bicycle pedal with fixed resistance for 30 seconds 14. Lateral Bridge R/L (seconds), isometric hold for 30 seconds 15. Lower Y Balance Test R/L (seconds), multi-planar movement to test lower body balance 16. Supine Bridge R/L (seconds), isometric hold until exhaustion 17. Upper Y Balance Test R/L (seconds), multi-planar movement to test upper body balance 18. Diastolic blood pressure (mmHg), average of three readings taken at rest 19. Systolic blood pressure (mmHg), average of three readings taken at rest 20. Maximum heart rate (beats/minute), measured with electronic monitor 21. Resting heart rate (beats/minute, measured with electronic monitor 22. Lean muscle mass (pounds), measured with DEXA overall and segmented body composition Primary cognitive measures, all measured at both pre- and post-intervention (12 weeks): 1. Immediate Free Recall Words (from previously seen words, recall as many as possible) 2. Immediate Free Recall Pictures (from previously seen pictures, recall as many as possible) 3. Keep Track (of the last instance of a given category) 4. Paired Associates Immediate Recall (given one word from a pair already seen, recall the other word in the pair immediately) 5. Paired Associates Delayed Recall (given one word from a pair already seen, recall the other word in the pair after a delay) 6. Number Series (identify the pattern in a sequence of numbers) 7. Letter Series (identify the pattern in a sequence of letters) 8. Symmetry Span (hold items in memory while checking symmetry in a matrix) 9. Rotation Span (hold items in memory while rotating letters) 10. Stroop Task (determine if the font color and word match) 11. Symbol Digit Modalities (use a lookup table to translate symbols into numbers quick as possible) |
| Secondary outcome measures | All measured at both pre- and post-intervention (12 weeks): 1. Cortisol (ug/dL) measured using blood test 2. Ferritin (ng/mL) measured using blood test 3. Folate (ng/mL) measured using blood test 4. High-Density Lipoprotein (mg/dL) measured using blood test 5. Low-Density Lipoprotein (mg/dL) measured using blood test 6. Triglycerides (mg/dL) measured using blood test 7. Vitamin B12 (pg/mL) measured using blood test 8 Saturated Fatty Acids (mol %) measured using blood test 9. Monounsaturated Fatty Acids (mol %) measured using blood test 10. Omega-3 PUFAs (mol %) measured using blood test 11. Omega-6 PUFAs (mol %) measured using blood test 12. Trans Fatty Acids (mol %) measured using blood test 13. Lutein density, measured in fovea and parafovea of eye using MPOD device |
| Overall study start date | 15/03/2015 |
| Overall study end date | 15/08/2018 |
Eligibility
| Participant type(s) | Other |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 200 |
| Total final enrolment | 203 |
| Participant inclusion criteria | 1. Active-duty Air Force status 2. Commit to study participation for 14 consecutive weeks 3. At least 18 but no older than 45 to minimize the risk of physical injury or cardiovascular occurrence due to the study’s required fitness activity |
| Participant exclusion criteria | Study participants shall not: 1. Have a Department of Defense medical profile for mental and/or physical function limitation nor have a pregnancy profile 2. Be currently be taking prescription blood pressure medication 3. Take herbal dietary supplements, performance supplements or any other substance that contained ingredients that might affect cardiovascular response with exercise one week before study participation begins 4. Have a musculoskeletal injury that would limit their ability to engage in heavy resistance training and aerobic exercise 5. Have cardiovascular or respiratory disease that would limit their ability to engage in heavy resistance training and aerobic exercise |
| Recruitment start date | 15/01/2016 |
| Recruitment end date | 15/05/2018 |
Locations
Countries of recruitment
- United States of America
Study participating centre
Bldg. 441
Wright-Patterson AFB, OH
Dayton
45433
United States of America
Sponsor information
University/education
506 S. Wright St.
Urbana
61801
United States of America
| Phone | +1 (0)217 333 0034 |
|---|---|
| OVCR@illinois.edu | |
| Website | http://illinois.edu/ |
"ROR" |
https://ror.org/047426m28 |
Funders
Funder type
Industry
Private sector organisation / For-profit companies (industry)
- Location
- United States of America
Results and Publications
| Intention to publish date | 25/07/2020 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not expected to be made available |
| Publication and dissemination plan | The study has been provisionally accepted at Scientific Reports, pending the registration of this trial in this database. |
| IPD sharing plan | The datasets generated during and/or analysed during the current study are not expected to be made available as this data was collected through the United States Air Force, so is considered CUI (controlled unclassified information). |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | 19/10/2020 | 18/08/2023 | Yes | No |
Editorial Notes
18/08/2023: Publication reference added.
27/07/2020: Trial's existence confirmed by Department of the Air Force, Air Force Research Laboratory, Wright-Patterson Air Force Base Institutional Review Board.
