Insulin-Like Growth Factor IPhase 2NCT05599282
The Efficacy and Safety of an Amino Acid Supplement in Adults
A Phase 2 study testing Amino Acid Supplement in people with Insulin-Like Growth Factor I and Healthy, run by ZandA Technologies, llc at 1 site in Canada.
Trial summary
The primary objective of this clinical trial is to determine the efficacy of once daily oral AAS use, as compared to placebo, in increasing serum IGF-1 concentrations within adults aged 35-75 years for up to 90 days. Read more about this study
- Who is it for?
- Ages 35 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Insulin-Like Growth Factor I, Healthy
- What is being tested?
- Amino Acid Supplement
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 1 siteCanada
- Study dates
- 26 Oct 2022to 22 Jan 2024
- Phase
- Phase 2
- 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 35 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Males and females between 35-75 years of age at baseline
- Weigh at least 52 kg for males and 45 kg for females
- BMI between 18.5-35.0 kg/m2, inclusive at screening
- Serum IGF-1 concentrations within ≤ 2 SDs of age-adjusted reference range as defined by the clinical laboratory
- Individual is not of child-bearing potential, defined as those who have undergone a sterilization procedure (e.g. hysterectomy, bilateral oophorectomy, bilateral tubal ligation, complete endometrial ablation) or have been post-menopausal for at least 1 year prior to screening
- Or,
Show all 17Show fewer
- Individuals of child-bearing potential must have a negative baseline urine pregnancy test and agree to use a medically approved method of birth control for the duration of the study. All hormonal birth control must have been in use for a minimum of three months. Acceptable methods of birth control include:
- Hormonal contraceptives including oral contraceptives, hormone birth control patch (Ortho Evra), vaginal contraceptive ring (NuvaRing), injectable contraceptives (Depo-Provera, Lunelle), or hormone implant (Norplant System)
- Double-barrier method
- Intrauterine devices
- Non-heterosexual lifestyle or agrees to use contraception if planning on changing to heterosexual partner(s)
- Vasectomy of partner at least 6 months prior to screening
- Provided voluntary, written, informed consent to participate in the study.
- Agrees to maintain current lifestyle habits throughout the study, including medications, supplements, and sleep.
- Agrees to avoid taking new supplements.
- Willingness to complete study assessments, journals, and all clinic visits
- Deemed eligible to participate as determined by medical history, laboratory results, and physical exam as assessed by QI
Who cannot join
- Individuals who are pregnant, breast feeding, or planning to become pregnant during the study
- Allergy, sensitivity, or intolerance to investigational product (IP) and/or placebo active or inactive ingredients
- Has a condition known to directly involve and/or affect IGF-1, including acromegaly, dwarfism, malnutrition, pituitary disorders, and Laron Syndrome
- Current or history of any significant diseases involving dementia (e.g., Alzheimer's disease, vascular dementia, etc.)
- Cancer, except skin basal cell carcinoma completely excised with no chemotherapy or radiation with a follow up that is negative. Volunteers with cancer in full remission for more than five years after diagnosis are acceptable.
- Current diagnosis or history of chronic kidney disease (creatinine levels > 1.1 mg/dl for women; > 1.2 mg/dl for men)
Show all 23Show fewer
- Current diagnosis or history of a thyroid-related disorder and/or disease
- Current diagnosis of liver diseases
- Current diagnosis of primary hypercholesterolemia (LDL-C 160-189 mg/dl [4.1-4.8 mmol/l]; non-HDL-C 190-219 mg/dl [4.9-5.6 mmol/l])
- Current diagnosis of primary hypertriglyceridemia (triglycerides >150 mg/dl, fasting)
- Current diagnosis of stage 2 hypertension (> 140/90 mmHg)
- Current diagnosis of type 1 or type 2 diabetes mellitus (HbA1c > 6.5%)
- History or presence of gastrointestinal (including prior bariatric bypass surgery), hepatic or renal disease, or any other condition that may interfere with the absorption, distribution, metabolism, or excretion of IPs, based on the opinion of the QI
- History of cardiovascular disease and/or significant cardiovascular event in the past 6 months. Participants with no significant cardiovascular event on stable medication may be included after assessment by the QI on a case-by-case basis
- History (within past two years at screening) or presence of diagnosis of alcohol abuse, a substance abuse disorder, known drug dependence, or seeking treatment for alcohol or substance abuse related disorder.
- Current use of prescribed medications, over-the-counter (OTC) medications, or supplements which may affect the efficacy and/or safety of the IP
- Individuals who work or plan to work night shifts
- Individuals who have travelled to other time zones within two weeks prior to baseline or plan to travel to other time zones during the study
- Alcohol intake average of > 2 standard drinks per day as assessed by the QI
- Clinically significant abnormal laboratory results at screening as assessed by the QI
- Participation in other clinical research studies 30 days prior to enrollment will be assessed on a case-by-case basis by the QI
- Individuals who are unable to give informed consent
- Any other condition or lifestyle factor, that, in the opinion of the QI, may adversely affect the participant's ability to complete the study or its measures or pose significant risk to the participant
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A 90-day, Double-blind, Placebo-controlled, Randomized, Parallel-Group Efficacy and Safety Study of an Amino Acid Supplement in Adults
The primary objective of this clinical trial is to determine the efficacy of once daily oral AAS use, as compared to placebo, in increasing serum IGF-1 concentrations within adults aged 35-75 years for up to 90 days. Additionally, the safety and tolerability of the AAS, as compared to placebo, will be measured by the occurrence of and/or changes in treatment-emergent adverse events (AEs).
For the study population, the eligibility criteria limit the presence of confounding variables that could influence study outcomes. Participants will be men and women between 35 and 75 years of age to account for the age range in which humans experience a decline in HGH/IGF-1. Each participant will be deemed eligible to participate by the Qualified Investigator (QI) by means of an extensive review of medical history, laboratory results, and physical examination. Participants will be required to have body mass index (BMI) measurements between 18.5 and 35.0 kg/m2 to ensure that their body weight/composition will not have a confounding effect on their HGH levels (18, 19) and to facilitate generalizability. Participants will be required to maintain current medication and supplements use and sleep throughout the study. They must also abstain from any over-the counter (OTC) medications and/or supplements that may affect the efficacy or safety of the AAS.
- Conditions
- Insulin-Like Growth Factor I, Healthy
- Being tested
- Amino Acid Supplement, Placebo
- Keywords
- Safety and Efficacy, Amino Acid Supplement
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Amino Acid SupplementDrug
Four capsules of Amino Acid Supplement will be taken once a day for 90 days.
PlaceboOther
Four capsules of Placebo will be taken once a day for 90 days.
| Study group | Role | What they receive |
|---|---|---|
| Amino Acid Supplement | Experimental | Participants will be instructed to take four (4) capsules of Amino Acid Supplement with a full glass of water daily for up to 90 days, starting on day 1. No substance other than water (i.e., food, drink other than water, and/or medication, supplement, vitamin, and/or mineral) can be consumed two hours before or after taking the Investigational Product (IP). The IP must be consistently consumed immediately before nighttime sleep throughout the study.
If a dose is missed participants are instructed to record the missed dose in their study journal. Missed doses will not be taken at a later time or date. If any substance other than water is consumed two hours before or after taking the IP, that IP use will be counted as a missed dose. Participants will be advised not to exceed four (4) capsules daily. Receives: Drug: Amino Acid Supplement |
| Placebo | Placebo comparator | Participants will be instructed to take four (4) capsules of Placebo with a full glass of water daily for up to 90 days, starting on day 1. No substance other than water (i.e., food, drink other than water, and/or medication, supplement, vitamin, and/or mineral) can be consumed two hours before or after taking the placebo. The placebo must be consistently consumed immediately before nighttime sleep throughout the study.
If a dose is missed participants are instructed to record the missed dose in their study journal. Missed doses will not be taken at a later time or date. If any substance other than water is consumed two hours before or after taking the placebo, that placebo use will be counted as a missed dose. Participants will be advised not to exceed four (4) capsules daily. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
The difference in serum IGF-1 concentrations from baseline up to 30 days of supplementation between Amino Acid Supplement (AAS) compared to placebo.
The difference in serum IGF-1 concentrations (ng/ml) from baseline (day 1) to 30 days (day 31) of supplementation between AAS will be compared to placebo
Measured: baseline (day 1) and 31 days
The difference in serum IGF-1 concentrations from baseline up to 60 days of supplementation between Amino Acid Supplement (AAS) compared to placebo.
The difference in serum IGF-1 concentrations (ng/ml) from baseline (day 1) up to 60 days (day 61) of supplementation between AAS will be compared to placebo
Measured: baseline (day 1) and 61 days
The difference in serum IGF-1 concentrations from baseline up to 90 days of supplementation between Amino Acid Supplement (AAS) compared to placebo.
The difference in serum IGF-1 concentrations (ng/ml) from baseline (day 1) up to 90 days (day 91) of supplementation between AAS will be compared to placebo
Measured: baseline (day 1) and 91 days
Secondary outcomes (2)
Incidence of pre-emergent adverse events following 90 days of supplementation with Amino Acid Supplement (AAS) compared to placebo
Incidence of pre-emergent adverse events following 90 days of supplementation with Amino Acid Supplement (AAS) will be compared to placebo. A follow-up safety call will also be conducted 2 weeks after the 90 day treatment (day 105) with Amino Acid Supplement.
Measured: 105 days
Incidence of post-emergent adverse events following 90 days of supplementation with Amino Acid Supplement (AAS) compared to placebo
Incidence of post-emergent adverse events following 90 days of supplementation with Amino Acid Supplement (AAS) will be compared to placebo. A follow-up safety call will also be conducted 2 weeks after the 90 day treatment (day 105) with Amino Acid Supplement.
Measured: 105 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2022
- Study start26 Oct 2022
- Primary completion8 Jan 2024
- Study completion22 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Insulin-Like Growth Factor IStudies of the same condition, open and under way.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- ZandA Technologies, llc
- Sponsor type
- University, hospital or other
- Collaborators
- KGK Science Inc.
- Responsible party
- Sponsor
- Investigators
- David Crowley, MD, Principal investigator, KGK Science Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05599282
- Sponsor's protocol ID
- 21ZTCPS01
- Status last verified
- Apr 2024
- First submitted
- 20 Oct 2022
- Last updated
- 4 Apr 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A 90-day, Double-blind, Placebo-controlled, Randomized, Parallel-Group Efficacy and Safety Study of an Amino Acid Supplement in Adults
- ClinicalTrials.gov ID
- NCT05599282
- Acronym / sponsor ID
- 21ZTCPS01
- Conditions
- Insulin-Like Growth Factor I, Healthy
- Keywords
- Safety and Efficacy, Amino Acid Supplement
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- ZandA Technologies, llcUniversity, hospital or other
- Collaborators
- KGK Science Inc.
- Study start
- 26 Oct 2022 (actual)
- Primary completion
- 8 Jan 2024 (actual)
- Study completion
- 22 Jan 2024 (actual)
- First posted
- 31 Oct 2022 (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.
The primary objective of this clinical trial is to determine the efficacy of once daily oral AAS use, as compared to placebo, in increasing serum IGF-1 concentrations within adults aged 35-75 years for up to 90 days. Additionally, the safety and tolerability of the AAS, as compared to placebo, will be measured by the occurrence of and/or changes in treatment-emergent adverse events (AEs).
For the study population, the eligibility criteria limit the presence of confounding variables that could influence study outcomes. Participants will be men and women between 35 and 75 years of age to account for the age range in which humans experience a decline in HGH/IGF-1. Each participant will be deemed eligible to participate by the Qualified Investigator (QI) by means of an extensive review of medical history, laboratory results, and physical examination. Participants will be required to have body mass index (BMI) measurements between 18.5 and 35.0 kg/m2 to ensure that their body weight/composition will not have a confounding effect on their HGH levels (18, 19) and to facilitate generalizability. Participants will be required to maintain current medication and supplements use and sleep throughout the study. They must also abstain from any over-the counter (OTC) medications and/or supplements that may affect the efficacy or safety of the AAS.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Amino Acid Supplement | Experimental | Drug: Amino Acid SupplementParticipants will be instructed to take four (4) capsules of Amino Acid Supplement with a full glass of water daily for up to 90 days, starting on day 1. No substance other than water (i.e., food, drink other than water, and/or medication, supplement, vitamin, and/or mineral) can be consumed two hours before or after taking the Investigational Product (IP). The IP must be consistently consumed immediately before nighttime sleep throughout the study. If a dose is missed participants are instructed to record the missed dose in their study journal. Missed doses will not be taken at a later time or date. If any substance other than water is consumed two hours before or after taking the IP, that IP use will be counted as a missed dose. Participants will be advised not to exceed four (4) capsules daily. |
| Placebo | Placebo comparator | Other: PlaceboParticipants will be instructed to take four (4) capsules of Placebo with a full glass of water daily for up to 90 days, starting on day 1. No substance other than water (i.e., food, drink other than water, and/or medication, supplement, vitamin, and/or mineral) can be consumed two hours before or after taking the placebo. The placebo must be consistently consumed immediately before nighttime sleep throughout the study. If a dose is missed participants are instructed to record the missed dose in their study journal. Missed doses will not be taken at a later time or date. If any substance other than water is consumed two hours before or after taking the placebo, that placebo use will be counted as a missed dose. Participants will be advised not to exceed four (4) capsules daily. |
Who may qualify
- Ages
- 35 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- Males and females between 35-75 years of age at baseline
- Weigh at least 52 kg for males and 45 kg for females
- BMI between 18.5-35.0 kg/m2, inclusive at screening
- Serum IGF-1 concentrations within ≤ 2 SDs of age-adjusted reference range as defined by the clinical laboratory
- Individual is not of child-bearing potential, defined as those who have undergone a sterilization procedure (e.g. hysterectomy, bilateral oophorectomy, bilateral tubal ligation, complete endometrial ablation) or have been post-menopausal for at least 1 year prior to screening
Key exclusion criteria (23 listed)
- Individuals who are pregnant, breast feeding, or planning to become pregnant during the study
- Allergy, sensitivity, or intolerance to investigational product (IP) and/or placebo active or inactive ingredients
- Has a condition known to directly involve and/or affect IGF-1, including acromegaly, dwarfism, malnutrition, pituitary disorders, and Laron Syndrome
- Current or history of any significant diseases involving dementia (e.g., Alzheimer's disease, vascular dementia, etc.)
- Cancer, except skin basal cell carcinoma completely excised with no chemotherapy or radiation with a follow up that is negative. Volunteers with cancer in full remission for more than five years after diagnosis are acceptable.
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 |
|---|---|---|
| Amino Acid SupplementFour capsules of Amino Acid Supplement will be taken once a day for 90 days. | Drug | Amino Acid Supplement |
| PlaceboFour capsules of Placebo will be taken once a day for 90 days. | Other | Placebo |
Primary outcome
The difference in serum IGF-1 concentrations from baseline up to 30 days of supplementation between Amino Acid Supplement (AAS) compared to placebo.
Time frame: baseline (day 1) and 31 days
The difference in serum IGF-1 concentrations (ng/ml) from baseline (day 1) to 30 days (day 31) of supplementation between AAS will be compared to placebo
The difference in serum IGF-1 concentrations from baseline up to 60 days of supplementation between Amino Acid Supplement (AAS) compared to placebo.
Time frame: baseline (day 1) and 61 days
The difference in serum IGF-1 concentrations (ng/ml) from baseline (day 1) up to 60 days (day 61) of supplementation between AAS will be compared to placebo
The difference in serum IGF-1 concentrations from baseline up to 90 days of supplementation between Amino Acid Supplement (AAS) compared to placebo.
Time frame: baseline (day 1) and 91 days
The difference in serum IGF-1 concentrations (ng/ml) from baseline (day 1) up to 90 days (day 91) of supplementation between AAS will be compared to placebo
2 secondary outcomes
Incidence of pre-emergent adverse events following 90 days of supplementation with Amino Acid Supplement (AAS) compared to placebo
Time frame: 105 days
Incidence of post-emergent adverse events following 90 days of supplementation with Amino Acid Supplement (AAS) compared to placebo
Time frame: 105 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 2024.
Related trials for Insulin-Like Growth Factor I
Recruiting
Multimodal Assessment of NMES Effects on Respiratory and Peripheral Muscles in COPD
Chronic Obstructive Pulmonary Disease (COPD), Respiratory Muscle Dysfunction
Not yet recruitingPhase 2
Ceritinib Treatment for Recurrent Meningiomas
Recurrent Meningioma, Grade I and Grade II
RecruitingPhase 3
A Study to Assess the Efficacy and Safety of Debio 4126 in Participants With Acromegaly Previously Treated With Somatostatin Analogs
Acromegaly
Recruiting
Effect of Resistance Exercises on Serum IGF-1 Levels in Knee Osteoarthritis
Osteoarthritis (Knee), Metabolic Syndrome (MetS)
Not yet recruitingObservational study
The AgRP and GH/IGF-1 Axis in Children
Growth Hormone Deficiency
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.
David Crowley, MD principal investigator
KGK Science Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Amino Acid Supplement in people with Insulin-Like Growth Factor I and Healthy, run by ZandA Technologies, llc at 1 site in Canada.
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 17 inclusion and 23 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: finished, as of the sponsor's last update on 4 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
The difference in serum IGF-1 concentrations from baseline up to 30 days of supplementation between Amino Acid Supplement (AAS) compared to placebo. (time frame: baseline (day 1) and 31 days). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 4 Apr 2024.