N/A
N=80
Study Evaluating the Effects of Dietary Supplement on Hair Thickness and Hair Strength in Individuals With Self-Perceived Thinning Hair
Hair Thinning
Bottom Line
View on ClinicalTrials.gov: NCT06605768 ↗Enrolled (actual)
80
Serious AEs
0.0%
Results posted
Feb 2026
Primary outcome: Primary: Hair Shedding (1-2 Hairs Per Unit) — 21; 10 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Complex with Biotin, Collagen, Keratin, Hyaluronic Acid. (Dietary_supplement); Placebo product (Dietary_supplement)
- Age
- Adult · 21+ yrs
- Sex
- All
- Sponsor
- Nutra Harmony LLC
- Primary completion
- Jul 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Hair Shedding (1-2 Hairs Per Unit) |
21; 10 | — |
| SECONDARY Hair Thinning |
17; 7 | — |
| SECONDARY Increase in the Amount of Vellus Hair Compared to Mature Hairs |
14; 22 | — |
| SECONDARY Increased Distance Between Units |
12; 5 | — |
| SECONDARY Inflammatory Processes in the Scalp and Blood Vessels |
20; 6 | — |
Summary
The Nutra Harmony "Biotin, Collagen & Keratin Beauty Complex" is an oral food/dietary supplement specifically designed to promote hair growth for people suffering from temporary thinning hair. The hypothesis of this clinical research study is that the ingestion of "Biotin, Collagen & Keratin Beauty Complex" for over a three (3) month period will strengthen the hair and increase hair thickness by promoting the growth of terminal hairs in subjects, ages 21-50 years of age with self-perceived thinning hair associated with poor diet, stress, hormonal influences when compared to using the placebo tablet.
Eligibility Criteria
Inclusion Criteria
- Individuals, ages 21-50 years of age.
- Clinically-determined general good health as determined by responses to the initial study assessment.
- Individuals with self-perceived thinning hair associated with poor diet, stress, hormone influences.
- Individuals willing to maintain their normal hair shampooing frequency.
- Individuals willing to add the provided oral supplement to their current daily routine.
- Individuals willing to not substantially change their current diet, medications, or exercise routines for the duration of the study. If a subject receives physician guidance during the study to change diet, medications, or exercise routine, the subject will need to notify the clinic as soon as possible.
- Individuals willing to undergo a physical exam to include height, weight, blood pressure, pulse, general physical findings, scalp exam and blood sample collection.
- Individuals with Fitzpatrick I-IV photo skin types.
- Willingness to have digital photography of the target area and scalp for hair counts at Visits 1, 2, 3, 4, 5, 6.
- Willingness to have their hair washed (shampooed) over a sink containing cheesecloth for hair shedding counts at Visit 1, 2, 3, 4, 5, 6.
- Willingness to maintain a consistent haircut and hair color throughout the 3-months study period and to come to visits with clean (shampoo must be done 24 hours or more prior to the visit) and dry hair.
- Willingness of subjects who have color treated hair to have the color treatment performed at the same time interval prior to each visit (i.e. If on Visit 1 the color treatment was done one week prior then the color treatment is expected to occur at a similar interval of one week prior to Visit 2, 3 ,4 ,5, 6).
- Provision of signed and dated informed consent form.
Exclusion Criteria
- Individuals with a known history of intolerance or allergy to fish, seafood/shellfish or acerola.
- Individuals with any known allergy or sensitivity to any shampoo/conditioner.
- Females who are nursing, pregnant, planning to become pregnant during the study.
- Individuals with known stressful incident within the last six months (i.e. death in family, miscarriage).
- Individuals who are participating on any clinical research study at another research center or doctor's office.
- Females who have recently (within the last 6 months) started the use of hormones for birth control or hormone replacement therapy (HRT). Women currently using hormones for birth control or HRT must have been on a stable dose (6 months or longer) in order to be eligible for the study.
- Individuals currently using light therapy to treat thinning hair.
- Individuals who have regularly used Rogaine (Minoxidil) within the last 3 months.
- Individuals currently using any other biotin/keratin/collagen supplements.
- Individuals who have used prescription drugs known to affect the hair growth cycle within the last 6 months (e.g., hormone-based birth control for less than 6 months, cyproterone acetate, Aldactone/spironolactone, Finasteride or any 5-alpha-reductase inhibitor).
- Individuals suffering from other hair loss disorders, such as alopecia areata, scarring alopecia, androgenetic alopecia and telogen effluvium as determined on initial study assessment by the Investigator.
- Individuals with self-reported uncontrolled diseases (i.e. diabetes, hypertension, hyperthyroidism, hypothyroidism, etc.). Medical conditions that are under control with or without treatment will be considered on an individual basis by the Investigators.
- Individuals with self-reported active hepatitis, immune deficiency, HIV or autoimmune disease.
- Individuals having a known active dermatologic condition which, in the opinion of the examining Investigators, might place the subject at a greater risk or interfere with clinical evaluations (e.g., seborrheic dermatitis, psoriasis, atopic dermatitis, advanced skin cancer, etc.).
Data sourced from ClinicalTrials.gov (NCT06605768). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.