Effects of Dietary Supplements on Nail and Hair Health

Standard Process

Status: Not yet enrolling

Conditions: Nutrient Intake Inadequacy; Nutrient Intake

Treatments: Dietary Supplement: Active Control (Gastro-Fiber); Dietary Supplement: Immune Health (Immuplex); Dietary Supplement: Immune Health (Congaplex)

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT07373574

Pro00088817 (Other Identifier)

SPD-01

Details and patient eligibility

About

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. We value your participation.

Full 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® supplements.

Enrollment: 90 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. Healthy female and male adults who are 18 to 75 years of age (inclusive)

2. Display longitudinal (vertical) nail ridges in the absence of other nail abnormalities

3. 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)

4. In good general health (no uncontrolled diseases or conditions) as deemed by the investigator and is able to consume the study product

5. 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:

   1. 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 contraceptive 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
   2. 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 intercourse that may result in pregnancy; or
   3. vasectomy of partner at least 6 months prior to the first dose of study product.

   A participant of childbearing potential must use 1 highly effective contraceptive method during the study or use the double-barrier method during the study. 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.

6. Agree to refrain from treatments listed in Section 8.3 in the defined timeframe.

7. 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.

8. Willing and able to agree to the requirements and restrictions of this study, be willing to give voluntary consent, be able to understand and read the questionnaires, and carry out all study-related procedures.

Exclusion criteria

1. Individuals who are lactating, pregnant or planning to become pregnant during the study as confirmed at the baseline visit (Visit 2)
2. Individuals who have applied cosmetic/topical treatments to fingernails in the past 6 months (i.e., manicures with nail plate filing, nail polish)
3. 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])
4. Have a known sensitivity, intolerability, or allergy to any of the study products or their excipients
5. Currently has COVID-19 or tests positive for COVID-19 within 28 days prior to baseline visit
6. Individuals opposed to consuming animal products
7. Have a history of uncontrolled hypertension (140/90 or greater mmHg), kidney dysfunction or disease (dialysis or renal failure), hepatic impairment or disease.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

90 participants in 3 patient groups

Congaplex

Experimental group

Description:

TP1: 6 capsules/day

Treatment:

Dietary Supplement: Immune Health (Congaplex)

Immuplex

Experimental group

Description:

TP2: 6 capsules/day

Treatment:

Dietary Supplement: Immune Health (Immuplex)

Gastro-Fiber

Active Comparator group

Description:

AC: 6 capsules/day

Treatment:

Dietary Supplement: Active Control (Gastro-Fiber)