ACL InjuryNCT03614351
Dietary Protein Intake and Rehabilitation From Anterior Cruciate Ligament Surgery
A study testing Protein (PROT) in people with ACL Injury, run by Wake Forest University Health Sciences.
Trial summary
Protein supplementation may promote increases in strength and hypertrophy in the context of resistance training (RT) and reduce markers of inflammation, while sufficient levels of protein are necessary for healing certain wounds and maintenance of muscle mass in a protein depleted state. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- ACL Injury
- What is being tested?
- Protein (PROT)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Oct 2021to Jun 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Participants with a complete ACL tear and received a hamstring autograft ACL repair surgery (within 8 months of injury) and plan to complete physical therapy and follow up treatment with WFBH at D1 outpatient rehabilitation
- Subjects must have a smartphone capable of running the nutrition tracking app (My Fitness Pal)
Who cannot join
- Subjects must not have other ligamentous involvement, or complications during the surgical procedure.
- They must not have had a concurrent meniscal repair (debridement is acceptable).
- They must not have post-operative limitations that interfere with rehabilitation.
- Patients determined by the referring surgeon to be poor candidates for the study for any medical (including history of eating disorder, phenylketonuria, maple syrup urine disease, food allergies, lactose intolerance, kidney or liver disease) or other reasons that deem them inappropriate to complete the intervention (driving distance from facility, work schedule that prohibits therapy treatments, dietary restrictions) will be excluded.
- Females who are pregnant will not be permitted in the study.
About this study
Official title: The Effects of Providing Protein and Nutritional Guidance on Healing Times After ACL Surgery
Protein supplementation may promote increases in strength and hypertrophy in the context of resistance training (RT) and reduce markers of inflammation, while sufficient levels of protein are necessary for healing certain wounds and maintenance of muscle mass in a protein depleted state. Protein supplementation could be useful to improve clinical outcomes.
Read the detailed description
Protein supplementation may promote increases in strength and hypertrophy in the context of resistance training (RT) and reduce markers of inflammation, while sufficient levels of protein are necessary for healing certain wounds and maintenance of muscle mass in a protein depleted state. Despite this, no studies have investigated the role of protein provision in the context of physical therapy (PT) or musculoskeletal rehabilitation, including following surgical interventions. Survey data of Americans in the highest protein consuming age range (19-30 year old consuming 91 g/kg body weight/day), show they have an adequate protein intake to maintain nitrogen balance at baseline (85 g/kg). However, if patients under consume protein, as apparent in older adults (mean intake of 66 g/kg) these individuals will require more during times of tissue healing or could benefit with more in attempting to build back their strength through RT or PT. Thus, protein supplementation could be useful to improve clinical outcomes.
- Conditions
- ACL Injury
- Being tested
- Protein (PROT), Control (CONT)
- Keywords
- protein, nutritional guidance, ACL surgery
- Medical subject headings
- Anterior Cruciate Ligament Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Protein (PROT)Dietary supplement
Participants will receive Combat Protein Powder made by MusclePharm in an amount sufficient to take 80g daily until their next visit. They will be encouraged to ingest 40 g after exercise and 40 g before bed which will partly comprise their daily goal. They will be educated on the concept of complete high quality proteins, and that some proteins can facilitate muscle growth greater than others. Additionally, they will receive meal plan ideas and shopping tips that will facilitate healthy and economical protein consumption up to or beyond their daily goal.
Control (CONT)Other
Instructed not to alter their diet based on the app, and to continue to eat as they normally would.
| Study group | Role | What they receive |
|---|---|---|
| Physical Therapy plus Protein Supplement | Experimental | Participants will be randomized to the protein supplementation group, PROT, and will receive education from a dietary counselor on how to monitor protein intake using a smartphone app. Receives: Dietary Supplement: Protein (PROT) |
| Physical Therapy Control | Active comparator | Participants will be randomized to the enhanced-care control group, CONT, and will receive education from a dietary counselor on how to monitor protein intake using a smartphone app. Receives: Other: Control (CONT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of individuals that complied with treatment/intervention
Compliance among treatment group in meeting 2 g/kg protein goal as measured by protein tracking app and in protein supplements provided will be measured.
Measured: up to 6 months
Percentage of frequency individuals successfully used the protein tracking app
Compliance in usage of protein tracking app will be recorded. The number of days they logged in and recorded their intake vs. total potential days to provide % value of diet protein compliance.
Measured: up to 6 months
Percentage of physical therapy visits attended by individuals
Compliance in physical therapy will be recorded.
Measured: up to 6 months
Percentage counseling sessions attended by individuals
Compliance in attending nutritional counseling sessions will be recorded.
Measured: up to 6 months
Secondary outcomes (4)
Single Leg Hop Test
Functional healing time based on single leg hop test. The distance the participant hopped on one leg will be recorded and measured in centimeters. This will be done three times and an average will be given.
Measured: baseline and up to 6 month
Six Meter Timed Hop Test
Functional healing time based six meter timed hop test. The time it took the participant to hop six meters on foot will be measured and recorded.
Measured: baseline and up to 6 month
Change in strength in leg flexion and extension
Strength in leg flexion and extension, as measured by Biodex machine
Measured: baseline and up to 6 month
Change in muscle hypertrophy
depth of vastus medialis as measured at each nutritional advising appointment with counselor via ultrasound and thigh circumference.
Measured: baseline and up to 6 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2018
- Study startOct 2021 (estimated)
- Primary completionJan 2022 (estimated)
- Study completionJun 2022 (estimated)
Why it stopped: lack of funding to pay for a coordinator and interventionist,
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (28)Papers the sponsor has linked to this study.
- Other trials for ACL InjuryStudies of the same condition, open and under way.
- More trials run by Wake Forest University Health SciencesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wake Forest University Health Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Gary Miller, Ph.D., Principal investigator, Wake Forest University Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03614351
- Sponsor's protocol ID
- IRB00046590
- Status last verified
- Jul 2020
- First submitted
- 25 Jul 2018
- Last updated
- 2 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The IPD will be available for health history, surgery type, clinical outcomes, and length of time in study.
Publications
Mather RC 3rd, Koenig L, Kocher MS, Dall TM, Gallo P, Scott DJ, Bach BR Jr, Spindler KP; MOON Knee Group. Societal and economic impact of anterior cruciate ligament tears. J Bone Joint Surg Am. 2013 Oct 2;95(19):1751-9. doi: 10.2106/JBJS.L.01705.
PubMed 24088967Ohura T, Nakajo T, Okada S, Omura K, Adachi K. Evaluation of effects of nutrition intervention on healing of pressure ulcers and nutritional states (randomized controlled trial). Wound Repair Regen. 2011 May-Jun;19(3):330-6. doi: 10.1111/j.1524-475X.2011.00691.x.
PubMed 21539650Iizaka S, Kaitani T, Nakagami G, Sugama J, Sanada H. Clinical validity of the estimated energy requirement and the average protein requirement for nutritional status change and wound healing in older patients with pressure ulcers: A multicenter prospective cohort study. Geriatr Gerontol Int. 2015 Nov;15(11):1201-9. doi: 10.1111/ggi.12420. Epub 2014 Dec 11.
PubMed 25496092Hurt RT, McClave SA, Martindale RG, Ochoa Gautier JB, Coss-Bu JA, Dickerson RN, Heyland DK, Hoffer LJ, Moore FA, Morris CR, Paddon-Jones D, Patel JJ, Phillips SM, Rugeles SJ, Sarav Md M, Weijs PJ, Wernerman J, Hamilton-Reeves J, McClain CJ, Taylor B. Summary Points and Consensus Recommendations From the International Protein Summit. Nutr Clin Pract. 2017 Apr;32(1_suppl):142S-151S. doi: 10.1177/0884533617693610.
PubMed 28388374Pasiakos SM, McLellan TM, Lieberman HR. The effects of protein supplements on muscle mass, strength, and aerobic and anaerobic power in healthy adults: a systematic review. Sports Med. 2015 Jan;45(1):111-31. doi: 10.1007/s40279-014-0242-2.
PubMed 25169440Cresci GA. Nutrition Support for the Critically Ill Patient: A Guide to Practice. Boca Raton, FL. CRC Press, 2005.
Daly RM, O'Connell SL, Mundell NL, Grimes CA, Dunstan DW, Nowson CA. Protein-enriched diet, with the use of lean red meat, combined with progressive resistance training enhances lean tissue mass and muscle strength and reduces circulating IL-6 concentrations in elderly women: a cluster randomized controlled trial. Am J Clin Nutr. 2014 Apr;99(4):899-910. doi: 10.3945/ajcn.113.064154. Epub 2014 Jan 29.
PubMed 24477043Crickmer M, Dunne CP, O'Regan A, Coffey JC, Dunne SS. Benefits of post-operative oral protein supplementation in gastrointestinal surgery patients: A systematic review of clinical trials. World J Gastrointest Surg. 2016 Jul 27;8(7):521-32. doi: 10.4240/wjgs.v8.i7.521.
PubMed 27462395Fulgoni VL 3rd. Current protein intake in America: analysis of the National Health and Nutrition Examination Survey, 2003-2004. Am J Clin Nutr. 2008 May;87(5):1554S-1557S. doi: 10.1093/ajcn/87.5.1554S.
PubMed 18469286Campbell WW, Johnson CA, McCabe GP, Carnell NS. Dietary protein requirements of younger and older adults. Am J Clin Nutr. 2008 Nov;88(5):1322-9. doi: 10.3945/ajcn.2008.26072.
PubMed 18996869Antonio J, Ellerbroek A, Silver T, Vargas L, Tamayo A, Buehn R, Peacock CA. A High Protein Diet Has No Harmful Effects: A One-Year Crossover Study in Resistance-Trained Males. J Nutr Metab. 2016;2016:9104792. doi: 10.1155/2016/9104792. Epub 2016 Oct 11.
PubMed 27807480Naclerio F, Larumbe-Zabala E. Effects of Whey Protein Alone or as Part of a Multi-ingredient Formulation on Strength, Fat-Free Mass, or Lean Body Mass in Resistance-Trained Individuals: A Meta-analysis. Sports Med. 2016 Jan;46(1):125-137. doi: 10.1007/s40279-015-0403-y.
PubMed 26403469Fabre M, Hausswirth C, Tiollier E, Molle O, Louis J, Durguerian A, Neveux N, Bigard X. Effects of Postexercise Protein Intake on Muscle Mass and Strength During Resistance Training: Is There an Optimal Ratio Between Fast and Slow Proteins? Int J Sport Nutr Exerc Metab. 2017 Oct;27(5):448-457. doi: 10.1123/ijsnem.2016-0333. Epub 2017 Apr 19.
PubMed 28422532Alisson-Silva F, Kawanishi K, Varki A. Human risk of diseases associated with red meat intake: Analysis of current theories and proposed role for metabolic incorporation of a non-human sialic acid. Mol Aspects Med. 2016 Oct;51:16-30. doi: 10.1016/j.mam.2016.07.002. Epub 2016 Jul 12.
PubMed 27421909Schoenfeld BJ, Aragon A, Wilborn C, Urbina SL, Hayward SE, Krieger J. Pre- versus post-exercise protein intake has similar effects on muscular adaptations. PeerJ. 2017 Jan 3;5:e2825. doi: 10.7717/peerj.2825. eCollection 2017.
PubMed 28070459
Study at a glance
From the registry record, last updated by the sponsor on 2 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Providing Protein and Nutritional Guidance on Healing Times After ACL Surgery
- ClinicalTrials.gov ID
- NCT03614351
- Acronym / sponsor ID
- IRB00046590
- Conditions
- ACL Injury
- Keywords
- protein, nutritional guidance, ACL surgery
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: lack of funding to pay for a coordinator and interventionist,
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Wake Forest University Health SciencesUniversity, hospital or other
- Study start
- Oct 2021 (estimated)
- Primary completion
- Jan 2022 (estimated)
- Study completion
- Jun 2022 (estimated)
- First posted
- 3 Aug 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Protein supplementation may promote increases in strength and hypertrophy in the context of resistance training (RT) and reduce markers of inflammation, while sufficient levels of protein are necessary for healing certain wounds and maintenance of muscle mass in a protein depleted state. Protein supplementation could be useful to improve clinical outcomes.
Detailed description
Protein supplementation may promote increases in strength and hypertrophy in the context of resistance training (RT) and reduce markers of inflammation, while sufficient levels of protein are necessary for healing certain wounds and maintenance of muscle mass in a protein depleted state. Despite this, no studies have investigated the role of protein provision in the context of physical therapy (PT) or musculoskeletal rehabilitation, including following surgical interventions. Survey data of Americans in the highest protein consuming age range (19-30 year old consuming 91 g/kg body weight/day), show they have an adequate protein intake to maintain nitrogen balance at baseline (85 g/kg). However, if patients under consume protein, as apparent in older adults (mean intake of 66 g/kg) these individuals will require more during times of tissue healing or could benefit with more in attempting to build back their strength through RT or PT. Thus, protein supplementation could be useful to improve clinical outcomes.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Physical Therapy plus Protein Supplement | Experimental | Dietary Supplement: Protein (PROT)Participants will be randomized to the protein supplementation group, PROT, and will receive education from a dietary counselor on how to monitor protein intake using a smartphone app. |
| Physical Therapy Control | Active comparator | Other: Control (CONT)Participants will be randomized to the enhanced-care control group, CONT, and will receive education from a dietary counselor on how to monitor protein intake using a smartphone app. |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Participants with a complete ACL tear and received a hamstring autograft ACL repair surgery (within 8 months of injury) and plan to complete physical therapy and follow up treatment with WFBH at D1 outpatient rehabilitation
- Subjects must have a smartphone capable of running the nutrition tracking app (My Fitness Pal)
Key exclusion criteria (5 listed)
- Subjects must not have other ligamentous involvement, or complications during the surgical procedure.
- They must not have had a concurrent meniscal repair (debridement is acceptable).
- They must not have post-operative limitations that interfere with rehabilitation.
- Patients determined by the referring surgeon to be poor candidates for the study for any medical (including history of eating disorder, phenylketonuria, maple syrup urine disease, food allergies, lactose intolerance, kidney or liver disease) or other reasons that deem them inappropriate to complete the intervention (driving distance from facility, work schedule that prohibits therapy treatments, dietary restrictions) will be excluded.
- Females who are pregnant will not be permitted in the study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Protein (PROT)Participants will receive Combat Protein Powder made by MusclePharm in an amount sufficient to take 80g daily until their next visit. They will be encouraged to ingest 40 g after exercise and 40 g before bed which will partly comprise their daily goal. They will be educated on the concept of complete high quality proteins, and that some proteins can facilitate muscle growth greater than others. Additionally, they will receive meal plan ideas and shopping tips that will facilitate healthy and economical protein consumption up to or beyond their daily goal. | Dietary supplement | Physical Therapy plus Protein Supplement |
| Control (CONT)Instructed not to alter their diet based on the app, and to continue to eat as they normally would. | Other | Physical Therapy Control |
Primary outcome
Percentage of individuals that complied with treatment/intervention
Time frame: up to 6 months
Compliance among treatment group in meeting 2 g/kg protein goal as measured by protein tracking app and in protein supplements provided will be measured.
Percentage of frequency individuals successfully used the protein tracking app
Time frame: up to 6 months
Compliance in usage of protein tracking app will be recorded. The number of days they logged in and recorded their intake vs. total potential days to provide % value of diet protein compliance.
Percentage of physical therapy visits attended by individuals
Time frame: up to 6 months
Compliance in physical therapy will be recorded.
Percentage counseling sessions attended by individuals
Time frame: up to 6 months
Compliance in attending nutritional counseling sessions will be recorded.
4 secondary outcomes
Single Leg Hop Test
Time frame: baseline and up to 6 month
Six Meter Timed Hop Test
Time frame: baseline and up to 6 month
Change in strength in leg flexion and extension
Time frame: baseline and up to 6 month
Change in muscle hypertrophy
Time frame: baseline and up to 6 month
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Aug 2021.
- Background: PubMed 24088967Mather RC 3rd, Koenig L, Kocher MS, Dall TM, Gallo P, Scott DJ, Bach BR Jr, Spindler KP; MOON Knee Group. Societal and economic impact of anterior cruciate ligament tears. J Bone Joint Surg Am. 2013 Oct 2;95(19):1751-9. doi: 10.2106/JBJS.L.01705.
- Background: PubMed 21539650Ohura T, Nakajo T, Okada S, Omura K, Adachi K. Evaluation of effects of nutrition intervention on healing of pressure ulcers and nutritional states (randomized controlled trial). Wound Repair Regen. 2011 May-Jun;19(3):330-6. doi: 10.1111/j.1524-475X.2011.00691.x.
- Background: PubMed 25496092Iizaka S, Kaitani T, Nakagami G, Sugama J, Sanada H. Clinical validity of the estimated energy requirement and the average protein requirement for nutritional status change and wound healing in older patients with pressure ulcers: A multicenter prospective cohort study. Geriatr Gerontol Int. 2015 Nov;15(11):1201-9. doi: 10.1111/ggi.12420. Epub 2014 Dec 11.
- Background: PubMed 28388374Hurt RT, McClave SA, Martindale RG, Ochoa Gautier JB, Coss-Bu JA, Dickerson RN, Heyland DK, Hoffer LJ, Moore FA, Morris CR, Paddon-Jones D, Patel JJ, Phillips SM, Rugeles SJ, Sarav Md M, Weijs PJ, Wernerman J, Hamilton-Reeves J, McClain CJ, Taylor B. Summary Points and Consensus Recommendations From the International Protein Summit. Nutr Clin Pract. 2017 Apr;32(1_suppl):142S-151S. doi: 10.1177/0884533617693610.
- Background: PubMed 25169440Pasiakos SM, McLellan TM, Lieberman HR. The effects of protein supplements on muscle mass, strength, and aerobic and anaerobic power in healthy adults: a systematic review. Sports Med. 2015 Jan;45(1):111-31. doi: 10.1007/s40279-014-0242-2.
- BackgroundCresci GA. Nutrition Support for the Critically Ill Patient: A Guide to Practice. Boca Raton, FL. CRC Press, 2005.
- Background: PubMed 24477043Daly RM, O'Connell SL, Mundell NL, Grimes CA, Dunstan DW, Nowson CA. Protein-enriched diet, with the use of lean red meat, combined with progressive resistance training enhances lean tissue mass and muscle strength and reduces circulating IL-6 concentrations in elderly women: a cluster randomized controlled trial. Am J Clin Nutr. 2014 Apr;99(4):899-910. doi: 10.3945/ajcn.113.064154. Epub 2014 Jan 29.
- Background: PubMed 27462395Crickmer M, Dunne CP, O'Regan A, Coffey JC, Dunne SS. Benefits of post-operative oral protein supplementation in gastrointestinal surgery patients: A systematic review of clinical trials. World J Gastrointest Surg. 2016 Jul 27;8(7):521-32. doi: 10.4240/wjgs.v8.i7.521.
- Background: PubMed 18469286Fulgoni VL 3rd. Current protein intake in America: analysis of the National Health and Nutrition Examination Survey, 2003-2004. Am J Clin Nutr. 2008 May;87(5):1554S-1557S. doi: 10.1093/ajcn/87.5.1554S.
- Background: PubMed 18996869Campbell WW, Johnson CA, McCabe GP, Carnell NS. Dietary protein requirements of younger and older adults. Am J Clin Nutr. 2008 Nov;88(5):1322-9. doi: 10.3945/ajcn.2008.26072.
- Background: PubMed 27807480Antonio J, Ellerbroek A, Silver T, Vargas L, Tamayo A, Buehn R, Peacock CA. A High Protein Diet Has No Harmful Effects: A One-Year Crossover Study in Resistance-Trained Males. J Nutr Metab. 2016;2016:9104792. doi: 10.1155/2016/9104792. Epub 2016 Oct 11.
- Background: PubMed 26403469Naclerio F, Larumbe-Zabala E. Effects of Whey Protein Alone or as Part of a Multi-ingredient Formulation on Strength, Fat-Free Mass, or Lean Body Mass in Resistance-Trained Individuals: A Meta-analysis. Sports Med. 2016 Jan;46(1):125-137. doi: 10.1007/s40279-015-0403-y.
- Individual participant dataSharing planned: Yes. The IPD will be available for health history, surgery type, clinical outcomes, and length of time in study.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gary Miller, Ph.D. principal investigator
Wake Forest University Health Sciences
Questions about this trial
What is this clinical trial studying?
A study testing Protein (PROT) in people with ACL Injury, run by Wake Forest University Health Sciences.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 2 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of individuals that complied with treatment/intervention (time frame: up to 6 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03614351, which also lists 28 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Aug 2021.