Nutrient IntakeNCT07373574
Effects of Dietary Supplements on Nail and Hair Health
A study testing Immune Health (Congaplex) and Immune Health (Immuplex) in people with Nutrient Intake and Nutrient Intake Inadequacy, run by Standard Process Inc..
Trial summary
This is a research study conducted by Standard Process, Inc. and the University of North Carolina and Chapel Hill Nutrition Research Institute, which aims to evaluate the effectiveness of nutritional supplementation in improving the health of fingernails and hair. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Nutrient Intake, Nutrient Intake Inadequacy
- What is being tested?
- Immune Health (Congaplex) and Immune Health (Immuplex)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Sep 2026to 31 May 2027
- 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 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy female and male adults who are 18 to 75 years of age (inclusive)
- Display longitudinal (vertical) nail ridges in the absence of other nail abnormalities
- No cosmetic nail treatments that would mask the natural appearance of the nail plate in the past 6 months (i.e., manicure procedures that smooth the nail surface, nail polish)
- In good general health (no uncontrolled diseases or conditions) as deemed by the investigator and is able to consume the study product
- Individuals with childbearing potential must agree to practice an acceptable form of birth control for a certain timeframe prior to the first dose of study product and throughout the study, including:
- use for at least 3 months prior to the first dose of study product: hormonal contraceptives including oral contraceptives, hormone birth control patch (e.g., Ortho Evra), vaginal contra-ceptive ring (e.g., NuvaRing), injectable contraceptives (e.g., Depo-Provera, Lunelle), or hormone implant (e.g., Norplant System), or intrauterine devices (e.g., Mirena); or
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- use for at least 1 month prior to the first dose of study product: double-barrier method, non-hormonal intrauterine devices (i.e., copper), or complete abstinence from sexual inter-course that may result in pregnancy; or
- vasectomy of partner at least 6 months prior to the first dose of study product Individuals with the potential to impregnate others must agree to use condoms or other acceptable methods to prevent pregnancy throughout the study. Complete abstinence from sexual intercourse that may result in pregnancy is also acceptable.
- Agree to refrain from treatments listed in Section 8.3 in the defined timeframe
- Have maintained stable dietary habits (including supplement intake), exercise habits and lifestyle for the last 3 months prior to screening and agree to maintain dietary and exercise habits and lifestyle throughout the study
- Willing and able to agree to the requirements and restrictions of this study, be willing to give volun-tary consent, be able to understand and read the questionnaire, and carry out all study-related pro-cedures
Who cannot join
- Individuals who are lactating, pregnant or planning to become pregnant during the study as con-firmed at the baseline visit (Visit 2)
- Individuals who have applied cosmetic/topical treatments to fingernails in the past 6 months (i.e., manicures with nail plate filing, nail polish)
- Individuals who display nail abnormalities indicative of a health condition affecting nail appearance or have been diagnosed with a disease affecting nails (i.e., thickening, discoloration, horizontal nail ridges [Beau's lines])
- Individuals with active nail biting (onychophagia) or other behaviors that may affect nail integrity
- Have a known sensitivity, intolerability, or allergy to any of the study products or their excipients
- Currently has COVID-19 or tests positive for COVID-19 within 28 days prior to baseline visit
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- Individuals opposed to consuming animal products
- Have a history of uncontrolled hypertension (140/90 or greater mmHg), kidney dysfunction or dis-ease (dialysis or renal failure), hepatic impairment or disease
- Individuals who lack the capacity to provide informed consent, as determined by the study team based on cognitive impairment, altered mental status, or inability to understand the study and make an informed decision
About this study
Official title: Effects of the Dietary Supplements, Congaplex® and Immuplex®, on Age-Related Changes in Fingernail and Hair Health
This is a research study conducted by Standard Process, Inc. and the University of North Carolina and Chapel Hill Nutrition Research Institute, which aims to evaluate the effectiveness of nutritional supplementation in improving the health of fingernails and hair.
Read the detailed description
This study is a prospective, randomized, double-blind, controlled clinical trial focused on evaluating the effects of two nutritional supplements, Congaplex® (test product 1, TP1) and Immuplex® (TP2), versus an active control (AC) product, Gastro-Fiber®, on the health of fingernails and hair. The study will include a total of 90 participants across 3 arms and use a parallel-group design: 30 participants in TP1 group, 30 participants in TP2 group, and 30 participants in the AC group. The participants and the research personnel will be blind to the treatment. The AC product contains powder in capsules that have an identical size and similar appearance to Congaplex® and Immuplex®.
- Conditions
- Nutrient Intake, Nutrient Intake Inadequacy
- Being tested
- Immune Health (Congaplex), Active Control (Gastro-Fiber), Immune Health (Immuplex)
- Keywords
- Nutrition, Hair Health, Nail Health
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Immune Health (Congaplex)Dietary supplement
Supplement related to nail, hair, and immune health
Active Control (Gastro-Fiber)Dietary supplement
Supplement not related to immune, hair, or nail health
Immune Health (Immuplex)Dietary supplement
Supplement related to nail, hair, and immune health
| Study group | Role | What they receive |
|---|---|---|
| Congaplex | Experimental | TP1: 6 capsules/day Receives: Dietary Supplement: Immune Health (Congaplex) |
| Immuplex | Experimental | TP2: 6 capsules/day Receives: Dietary Supplement: Immune Health (Immuplex) |
| Gastro-Fiber | Active comparator | AC: 6 capsules/day Receives: Dietary Supplement: Active Control (Gastro-Fiber) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Determine the effects of test products (TP1/2) versus active control (AC) on numbers and severity of longitudinal (vertical) nail ridges
Changes in scores of vertical nail ridge numbers and severity according to Nail Score Chart will be determined at baseline (scores and pictures at V2), at 3 months (pictures only at V3) and 6 months (scores and pictures at V4) of supplementation
Measured: 6 months
Determine the effects of TP1/2 versus AC on nail biostructure and biochemical composition after 6 months of supplementation
Changes in Raman spectra of fingernail tissue at baseline (V2) compared to month 6 (V4) of supplementation
Measured: 6 months
Secondary outcomes (3)
Determine the effects of test products TP1/2 versus AC on density, thickness and pigmentation of hair
Changes in hair density, thickness and pigmentation from baseline to months 3 and 6 of supplementation, measured by trichoscopy. Trichoscopy is a non-invasive procedure that allows a dermatologist to examine the scalp and hair at a high magnification to detect hair and scalp changes.
Measured: 6 months
Determine the effects of TP1/2 versus AC on near vision (visual accommodation)
Change in near vision from baseline to months 3 and 6 of supplementation, measured using the Logarithmic Near Vis-ual Acuity Chart 2000 "New ETDRS"
Measured: 6 months
Determine the effects of TP1/2 versus AC on the scores of general health questionnaire
Changes in the total scores and subscores of a 36-Item Health Survey Instrument (SF-36) from baseline to months 3 and 6 of supplementation
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2026
- Study startSep 2026 (estimated)
- Primary completion1 May 2027 (estimated)
- Study completion31 May 2027 (estimated)
Why it stopped: Strategic change by sponsor
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 Nutrient IntakeStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Standard Process Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- UNC Nutrition Research Institute
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07373574
- Sponsor's protocol ID
- SPD-01
- Other IDs
- Pro00088817
- Status last verified
- Apr 2026
- First submitted
- 24 Sep 2025
- Last updated
- 20 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Hays RD, Morales LS. The RAND-36 measure of health-related quality of life. Ann Med. 2001 Jul;33(5):350-7. doi: 10.3109/07853890109002089.
PubMed 11491194Ferris FL 3rd, Kassoff A, Bresnick GH, Bailey I. New visual acuity charts for clinical research. Am J Ophthalmol. 1982 Jul;94(1):91-6.
PubMed 7091289Kim DY, Ahn H, Lee S, Jun I, Seo KY, Kim SY, Kim TI. Efficacy of a new refractive multifocal contact lens for presbyopia. Sci Rep. 2024 Apr 17;14(1):8878. doi: 10.1038/s41598-024-55918-5.
PubMed 38632261Ozeren E. Is C-reactive protein-albumin ratio or neutrophil-lymphocyte ratio a better indicator to predict in-hospital mortality in traumatic brain injury? Ulus Travma Acil Cerrahi Derg. 2022 Oct;28(10):1482-1487. doi: 10.14744/tjtes.2022.00794.
PubMed 36169474Baccaglini L, Theriaque DW, Shuster JJ, Serrano G, Lalla RV. Validation of anamnestic diagnostic criteria for recurrent aphthous stomatitis. J Oral Pathol Med. 2013 Apr;42(4):290-4. doi: 10.1111/jop.12015. Epub 2012 Oct 27.
PubMed 23106421Karincaoglu Y, Batcioglu K, Erdem T, Esrefoglu M, Genc M. The levels of plasma and salivary antioxidants in the patient with recurrent aphthous stomatitis. J Oral Pathol Med. 2005 Jan;34(1):7-12. doi: 10.1111/j.1600-0714.2004.00253.x.
PubMed 15610400Arikan S, Durusoy C, Akalin N, Haberal A, Seckin D. Oxidant/antioxidant status in recurrent aphthous stomatitis. Oral Dis. 2009 Oct;15(7):512-5. doi: 10.1111/j.1601-0825.2009.01580.x.
PubMed 19761497Edgar NR, Saleh D, Miller RA. Recurrent Aphthous Stomatitis: A Review. J Clin Aesthet Dermatol. 2017 Mar;10(3):26-36. Epub 2017 Mar 1.
PubMed 28360966Tappuni AR, Kovacevic T, Shirlaw PJ, Challacombe SJ. Clinical assessment of disease severity in recurrent aphthous stomatitis. J Oral Pathol Med. 2013 Sep;42(8):635-41. doi: 10.1111/jop.12059. Epub 2013 Mar 19.
PubMed 23509958Sanchez-Bernal J, Conejero C, Conejero R. Recurrent Aphthous Stomatitis. Actas Dermosifiliogr (Engl Ed). 2020 Jul-Aug;111(6):471-480. doi: 10.1016/j.ad.2019.09.004. Epub 2020 May 22. English, Spanish.
PubMed 32451064Chang H, Johnson E, Khoo C, Wang W, Gu L. Cranberry Juice Polyphenols Inhibited the Formation of Advanced Glycation End Products in Collagens, Inhibited Advanced Glycation End Product-Induced Collagen Crosslinking, and Cleaved the Formed Crosslinks. J Agric Food Chem. 2022 Dec 14;70(49):15560-15569. doi: 10.1021/acs.jafc.2c06502. Epub 2022 Dec 1.
PubMed 36455288Haus JM, Carrithers JA, Trappe SW, Trappe TA. Collagen, cross-linking, and advanced glycation end products in aging human skeletal muscle. J Appl Physiol (1985). 2007 Dec;103(6):2068-76. doi: 10.1152/japplphysiol.00670.2007. Epub 2007 Sep 27.
PubMed 17901242Aggarwala KRG. Ocular Accommodation, Intraocular Pressure, Development of Myopia and Glaucoma: Role of Ciliary Muscle, Choroid and Metabolism. Med Hypothesis Discov Innov Ophthalmol. 2020;9(1):66-70. Epub 2020 Jan 5.
PubMed 31976346Kuzuhara A, Fujiwara N, Hori T. Analysis of internal structure changes in black human hair keratin fibers with aging using Raman spectroscopy. Biopolymers. 2007 Oct 5-15;87(2-3):134-40. doi: 10.1002/bip.20805.
PubMed 17626296Brito ALB, Bruggen C, Ildiz GO, Fausto R. Investigation of menopause-induced changes on hair by Raman spectroscopy and chemometrics. Spectrochim Acta A Mol Biomol Spectrosc. 2022 Jul 5;275:121175. doi: 10.1016/j.saa.2022.121175. Epub 2022 Mar 21.
PubMed 35344858
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of the Dietary Supplements, Congaplex® and Immuplex®, on Age-Related Changes in Fingernail and Hair Health
- ClinicalTrials.gov ID
- NCT07373574
- Acronym / sponsor ID
- SPD-01
- Conditions
- Nutrient Intake, Nutrient Intake Inadequacy
- Keywords
- Nutrition, Hair Health, Nail Health
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Strategic change by sponsor
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Standard Process Inc.Industry (pharma, biotech, devices)
- Collaborators
- UNC Nutrition Research Institute
- Study start
- Sep 2026 (estimated)
- Primary completion
- 1 May 2027 (estimated)
- Study completion
- 31 May 2027 (estimated)
- First posted
- 28 Jan 2026 (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.
This is a research study conducted by Standard Process, Inc. and the University of North Carolina and Chapel Hill Nutrition Research Institute, which aims to evaluate the effectiveness of nutritional supplementation in improving the health of fingernails and hair.
Detailed description
This study is a prospective, randomized, double-blind, controlled clinical trial focused on evaluating the effects of two nutritional supplements, Congaplex® (test product 1, TP1) and Immuplex® (TP2), versus an active control (AC) product, Gastro-Fiber®, on the health of fingernails and hair. The study will include a total of 90 participants across 3 arms and use a parallel-group design: 30 participants in TP1 group, 30 participants in TP2 group, and 30 participants in the AC group. The participants and the research personnel will be blind to the treatment. The AC product contains powder in capsules that have an identical size and similar appearance to Congaplex® and Immuplex®.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Congaplex | Experimental | Dietary Supplement: Immune Health (Congaplex)TP1: 6 capsules/day |
| Immuplex | Experimental | Dietary Supplement: Immune Health (Immuplex)TP2: 6 capsules/day |
| Gastro-Fiber | Active comparator | Dietary Supplement: Active Control (Gastro-Fiber)AC: 6 capsules/day |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Healthy female and male adults who are 18 to 75 years of age (inclusive)
- Display longitudinal (vertical) nail ridges in the absence of other nail abnormalities
- No cosmetic nail treatments that would mask the natural appearance of the nail plate in the past 6 months (i.e., manicure procedures that smooth the nail surface, nail polish)
- In good general health (no uncontrolled diseases or conditions) as deemed by the investigator and is able to consume the study product
- Individuals with childbearing potential must agree to practice an acceptable form of birth control for a certain timeframe prior to the first dose of study product and throughout the study, including:
Key exclusion criteria (9 listed)
- Individuals who are lactating, pregnant or planning to become pregnant during the study as con-firmed at the baseline visit (Visit 2)
- Individuals who have applied cosmetic/topical treatments to fingernails in the past 6 months (i.e., manicures with nail plate filing, nail polish)
- Individuals who display nail abnormalities indicative of a health condition affecting nail appearance or have been diagnosed with a disease affecting nails (i.e., thickening, discoloration, horizontal nail ridges [Beau's lines])
- Individuals with active nail biting (onychophagia) or other behaviors that may affect nail integrity
- Have a known sensitivity, intolerability, or allergy to any of the study products or their excipients
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 |
|---|---|---|
| Immune Health (Congaplex)Supplement related to nail, hair, and immune health | Dietary supplement | Congaplex |
| Active Control (Gastro-Fiber)Supplement not related to immune, hair, or nail health | Dietary supplement | Gastro-Fiber |
| Immune Health (Immuplex)Supplement related to nail, hair, and immune health | Dietary supplement | Immuplex |
Primary outcome
Determine the effects of test products (TP1/2) versus active control (AC) on numbers and severity of longitudinal (vertical) nail ridges
Time frame: 6 months
Changes in scores of vertical nail ridge numbers and severity according to Nail Score Chart will be determined at baseline (scores and pictures at V2), at 3 months (pictures only at V3) and 6 months (scores and pictures at V4) of supplementation
Determine the effects of TP1/2 versus AC on nail biostructure and biochemical composition after 6 months of supplementation
Time frame: 6 months
Changes in Raman spectra of fingernail tissue at baseline (V2) compared to month 6 (V4) of supplementation
3 secondary outcomes
Determine the effects of test products TP1/2 versus AC on density, thickness and pigmentation of hair
Time frame: 6 months
Determine the effects of TP1/2 versus AC on near vision (visual accommodation)
Time frame: 6 months
Determine the effects of TP1/2 versus AC on the scores of general health questionnaire
Time frame: 6 months
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 20 Aug 2026.
- Background: PubMed 11491194Hays RD, Morales LS. The RAND-36 measure of health-related quality of life. Ann Med. 2001 Jul;33(5):350-7. doi: 10.3109/07853890109002089.
- Background: PubMed 7091289Ferris FL 3rd, Kassoff A, Bresnick GH, Bailey I. New visual acuity charts for clinical research. Am J Ophthalmol. 1982 Jul;94(1):91-6.
- Background: PubMed 38632261Kim DY, Ahn H, Lee S, Jun I, Seo KY, Kim SY, Kim TI. Efficacy of a new refractive multifocal contact lens for presbyopia. Sci Rep. 2024 Apr 17;14(1):8878. doi: 10.1038/s41598-024-55918-5.
- Background: PubMed 36169474Ozeren E. Is C-reactive protein-albumin ratio or neutrophil-lymphocyte ratio a better indicator to predict in-hospital mortality in traumatic brain injury? Ulus Travma Acil Cerrahi Derg. 2022 Oct;28(10):1482-1487. doi: 10.14744/tjtes.2022.00794.
- Background: PubMed 23106421Baccaglini L, Theriaque DW, Shuster JJ, Serrano G, Lalla RV. Validation of anamnestic diagnostic criteria for recurrent aphthous stomatitis. J Oral Pathol Med. 2013 Apr;42(4):290-4. doi: 10.1111/jop.12015. Epub 2012 Oct 27.
- Background: PubMed 15610400Karincaoglu Y, Batcioglu K, Erdem T, Esrefoglu M, Genc M. The levels of plasma and salivary antioxidants in the patient with recurrent aphthous stomatitis. J Oral Pathol Med. 2005 Jan;34(1):7-12. doi: 10.1111/j.1600-0714.2004.00253.x.
- Background: PubMed 19761497Arikan S, Durusoy C, Akalin N, Haberal A, Seckin D. Oxidant/antioxidant status in recurrent aphthous stomatitis. Oral Dis. 2009 Oct;15(7):512-5. doi: 10.1111/j.1601-0825.2009.01580.x.
- Background: PubMed 28360966Edgar NR, Saleh D, Miller RA. Recurrent Aphthous Stomatitis: A Review. J Clin Aesthet Dermatol. 2017 Mar;10(3):26-36. Epub 2017 Mar 1.
- Background: PubMed 23509958Tappuni AR, Kovacevic T, Shirlaw PJ, Challacombe SJ. Clinical assessment of disease severity in recurrent aphthous stomatitis. J Oral Pathol Med. 2013 Sep;42(8):635-41. doi: 10.1111/jop.12059. Epub 2013 Mar 19.
- Background: PubMed 32451064Sanchez-Bernal J, Conejero C, Conejero R. Recurrent Aphthous Stomatitis. Actas Dermosifiliogr (Engl Ed). 2020 Jul-Aug;111(6):471-480. doi: 10.1016/j.ad.2019.09.004. Epub 2020 May 22. English, Spanish.
- Background: PubMed 36455288Chang H, Johnson E, Khoo C, Wang W, Gu L. Cranberry Juice Polyphenols Inhibited the Formation of Advanced Glycation End Products in Collagens, Inhibited Advanced Glycation End Product-Induced Collagen Crosslinking, and Cleaved the Formed Crosslinks. J Agric Food Chem. 2022 Dec 14;70(49):15560-15569. doi: 10.1021/acs.jafc.2c06502. Epub 2022 Dec 1.
- Background: PubMed 17901242Haus JM, Carrithers JA, Trappe SW, Trappe TA. Collagen, cross-linking, and advanced glycation end products in aging human skeletal muscle. J Appl Physiol (1985). 2007 Dec;103(6):2068-76. doi: 10.1152/japplphysiol.00670.2007. Epub 2007 Sep 27.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Immune Health (Congaplex) and Immune Health (Immuplex) in people with Nutrient Intake and Nutrient Intake Inadequacy, run by Standard Process Inc..
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 11 inclusion and 9 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 20 Aug 2026. 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?
Determine the effects of test products (TP1/2) versus active control (AC) on numbers and severity of longitudinal (vertical) nail ridges (time frame: 6 months). The study lists 2 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 NCT07373574, 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 20 Aug 2026; AzTrials last refreshed its copy on 8 Nov 2026.