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N/A N=80 Randomized Single-blind Treatment

Study Evaluating the Effects of Dietary Supplement on Hair Thickness and Hair Strength in Individuals With Self-Perceived Thinning Hair

Hair Thinning

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

OutcomeResultp-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.).
View full record on ClinicalTrials.gov →

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.

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