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Effect of Miracle Fruit (Synsepalum Dulcificum) Seed Oil

on the Measurable Improvement of Hair Breakage in Women with Damaged

Hair: A Randomized, Double-blind, Placebo controlled, Eight-month Trial

ROBERTA DEL CAMPO, MD; YU ZHANG, PHD; and CHARLES WAKEFORD, PHD


ABSTRACT

Background:

Hair breakage is a common unrecognized form of hair loss in women most often the result of hair weathering and traumatic grooming practices. Lipids are major determinants of the physical properties of the hair. Synsepalum dulcificum seed oil (MFSO®; Miracle Fruit Oil Co., Miami Beach, Florida), is an exotic fruit oil with physicochemical properties suited to providing a superior ability to reduce hair breakage.


Objective:

To assess the safety and efficacy of a hair oil containing MFSO and its effects on hair breakage rates. Methods: Healthy, long-haired women (age range: 19–63 years, mean age: 36.7 years, standard deviation: 10.77 years) with excessive hair breakage were randomized in this double-blind, placebo-controlled study to receive MFSO (n=24), vehicle (n=17), or argan oil (n=16). Measurements of hair length, hair diameter, and Hair

Mass Index were performed at baseline, Month 4, and Month 8. Hair Breakage Index and the Healthy Hair Index values were calculated from the trichometer measurements, and subject self-assessment questionnaires were conducted. The primary efficacy endpoints were the percent change in Healthy Hair Index 75 and Healthy Hair Index 50 measurements from baseline to the eighth month. Results: The Healthy Hair Index calculations, expressed as percent change from baseline to Month 4 and from baseline to Month 8, revealed that the MFSO® treatment group improved by 103.6 percent and 215.7 percent for the Healthy Hair Index 75 and 133.7 and 188.3 percent for the Healthy Hair Index 50 values, respectively. When compared with the vehicle and the argan oil brand groups, the Healthy Hair Index levels were significantly higher (p < 0.001) for the MFSO® treatment group, indicating a much greater ability to increase the levels of unbroken hairs by reducing hair breakage. With respect to the mean percent improvements from baseline to Month 4 and Month 8, the MFSO® hair oil treatment group was better than each of the other two treatment groups by at least 117.6 percent

and 234.9 percent for the Healthy Hair Index 75 and 316.5 percent and 312 percent for the Healthy Hair Index 50 values, respectively, thereby achieving the primary efficacy objective. Subjects favored the MFSO® hair oil treatment, rating it as safe, effective, and aesthetically pleasing.


Conclusions:

The MFSO hair oil product is a safe and effective option for the treatment of women suffering from hair breakage and damaged hair. The aesthetic appearance of hair can

play an important role in people’s overall physical appearance, self-perception, and

self-confidence during social interactions. Hair breakage is a common but often unrecognized form of hair loss in women with long hair. 1, 2 It is frequently misdiagnosed as thinning due to female pattern hair loss or shedding due to telogen effluvium in women who present to the physician with complaints of hair loss. Although

certain nutritional and medical disorders can result in hair breakage, it is most often the result of hair weathering and grooming practices. 3–7 Hair shaft fragility results from natural aging and wear and tear due to exposure to a variety of environmental stresses, such as ultraviolet radiation, salt water, and pollution. 8–11 There are many common hair grooming practices that can cause structural damage to the hair fiber, causing the hair to break by producing mechano-physical and chemical insults. These include shampooing, combing, brushing, blow-drying, braiding, weaving, adding hair extensions, straightening, waving, perming, bleaching, dyeing, and the use of hot irons.

These traumatic hair care practices strip hair oils and cause the cuticle to become raised and porous, exposing the cortex to further damage, which can ultimately lead to reduced hair fiber strength and elasticity followed by fracture and hair loss. 12 Research studies designed to measure hair breakage have traditionally been conducted in laboratories using instrumentation that measures a single fiber’s tensile strength after

fatigue or on tresses of cut normal human hair in humidity-controlled environments.

13–15 After a single application of a test product, tresses are washed with water and exposed to bleach followed by repeated mechanical grooming. The detection of broken hair shafts is performed using a weight measuring method or by counting the number of individual broken hairs. However, the results from these biophysical in-vitro models might not be relevant to real-life situations in which many distinct consumer grooming habits and behavioral practices adversely affect the integrity of the hair. The trichometer offers clinicians an opportunity to quantitatively measure the severity of hair damage due to breakage and the response of the hair to various products in vivo. 16–20



ORIGINAL RESEARCH

Lipids are considered to be major determinants of the physical properties of hair, with the total amount in scalp hair being generally around 10 percent of the weight of the hair. Lipids contribute to the conditioning, defense, integrity, anti-aging, and maintenance of healthy hair. The normal function of scalp sebaceous glands is to produce and secrete sebum, a group of complex oils consisting mostly of triglycerides, fatty acids, wax esters composed mainly of palmitic acid, and squalene. In humans, wax esters and squalene are emollients that provide lubrication and are uniquely sebaceous. Squalene also acts as a potent antioxidant. The progressive loss of lipids, which tends to occur from the root to the distal end, due to normal weathering and grooming practices, contribute to a significant decrease in tensile properties of hair. Hair tends to break more easily at its distal end with longitudinal splitting, which leads to the common phenomenon of “split ends.” Sebum protects hairs from weathering and could also assist in repairing damaged hair by smoothing flaws, such as fragmented cracks and split ends. Application of naturally occurring oils from plants and fruit seeds has been known for centuries to help smooth, soften, shine, and otherwise condition human hair, leading to a healthy attractive appearance. The bioactive substances in oils that confer beneficial functional properties, such as moisturizing, conditioning, anti-inflammatory, and antioxidant activity, are largely contained within the non-saponifiable (non-soap forming) lipid (NSL) fraction of the oil.

In view of these findings, there exists a need to test the clinical efficacy of hair oils and compare their effects on preventing hair damage due to breakage. Synsepalum dulcificum seed oil, commonly known as Miracle Fruit Seed Oil® (MFSO®) (Miracle Fruit Oil Company, Miami Beach, Florida), is a rare and exotic fruit oil derived from the seed of the miracle fruit (MF) berry. The MF seed constitutes the greatest portion of the berry by weight, and its lipids are mainly composed of palmitic acid, the major fatty acid found in sebum, with a balanced saturated/ unsaturated fatty acid ratio of nearly 1:1. Due to its physicochemical properties, MFSO® is ideally suited to coat and penetrate the hair, thereby providing a superior ability to prevent hair damage and breakage.


METHODS

Study design. An eight-month, double blind, placebo-controlled, randomized clinical

study was performed to assess the efficacy of a hair oil formulation containing MFSO in

comparison with a placebo in terms of the ability to influence the percentage of broken

and unbroken hairs in adult long-haired women with excessively damaged hair. At each of the three study visits, hair breakage evaluations were performed on study participants with the use of a quantitative trichometer measuring device. In addition, the perception of the efficacy and degree of satisfaction with the use of the study product were assessed by users through self-assessment questionnaires. Ethical conduct and consent. All clinical study procedures were approved by the relevant institutional review board for the protection of human subjects, and the study protocol was conducted in accordance with the Declaration of Helsinki.


Exclusion comprised the following:

• Pregnancy or willingness to become pregnant during the study

• Having an episode of hair shedding in the past six months

• Being in the 12-month period following childbirth

• Being in the 12-month period following the discontinuation of a contraceptive drug

• Having a history of shampooing hair less than three times a week as part of their

current hair care regimen

• Taking a prescription or over-the-counter (OTC) medicine that could significantly

affect the study outcome within the past month

• Willing to take any new prescription drugs or OTC products that could significantly affect the study outcome;

• Willing to have their hair cut more than three inches in length;

• Willing to discontinue shampooing hair on different days at least three times a week

• Willing to continue the use of their current hair oil, if any

• Willing to substantially change their diet or daily routines

• An illness with fever in the past month

• A history of a scalp or hair loss disorder, such as alopecia, in the past 12 months

• A history of greater than 20 percent weight loss in the past 12 months

• A history of nutritional deficiency or being on a new diet in the past six months

• A history of a thyroid problem

• A history of medical or surgical event in the past year that may significantly affect the study outcome, including cardiovascular disease, metabolic, renal, hepatic, or musculoskeletal disorders

• A history of depression or severe anxiety in the past six months

• Participating in another clinical trial or taking an investigational product in the

past three months.



Inclusion criteria comprised the following:

• A hair length measurement of at least 12 inches

• A hair length measurement of at least 10 inches of the shortest layer if hair styled in a layered cut

• Evidence of significant hair breakage as defined by a HBI75 calculation of greater than 30 percent (subjects with negligible hair breakage generally have values less than 15%) as assessed with trichometer taken from a hair bundle located at a hair length of 75 percent from the scalp to the distal tips of hair.


Product.

The miracle fruit seeds were secured from local growers in Africa and the MFSO was extracted using standard supercritical CO2 fluid extraction methods. The unfractionated and unrefined virgin MFSO obtained directly from the extraction methods used, considered the highest quality grade of oil without undergoing any physical or chemical

modification, was the type of oil used in the clinical study. The hair oil treatment product

containing Synsepalum dulcificum seed oil (MFSO) and the vehicle control containing

no MFSO were formulated in a liquid silicone base and produced in the United States for the Miracle Fruit Oil Company (Miami Beach, Florida). A commercially available leading brand of hair oil treatment containing Argania spinosa kernel oil (argan oil) in a liquid silicone base was also utilized as a control. All hair oil treatment samples were received blinded at the study site, bottled (4oz) under code, stored at ambient humidity and temperature, and dispensed to study subjects using a random allocation sequence.

As part of the study, the MFSO was separated into fractions and the NSL fraction underwent laboratory investigations to identify the presence of certain classes of bioactive components that could be beneficial for hair care. Reference standards and other reagents for these studies were purchased from Sigma Aldrich (St. Louis, Missouri) and Thermo Fisher Scientific (Waltham, Massachusetts). The extraction of the NSL fraction of the MFSO and the thin layer chromatography (TLC) separation were performed as previously described with slight modification. Briefly, the extracted NSL

fraction of MFSO was separated using TLC on 20cm x 20cm plates coated with 0.3mm silica. After development, the spots were visualized with iodine-vapor staining for 20 minutes at 50°C.


Treatments.

The clinical study to determine the effects of the investigational hair oil treatment containing MFSO on its ability to increase the amount of unbroken hairs in long

haired women was designed as a single-center, randomized, double-blind, placebo-controlled, parallel design, institutional review board approved study. Participants were seen and evaluated by staff on three visits during the study: at an initial screening/baseline pre treatment visit (Visit 1), after four months of treatment (Visit 2), and after eight months of treatment at the end of the study (Visit 3). The study participants were randomly assigned a treatment using a web-based research randomizer (http://randomizer.org).


Efficacy assessments.

During all study visits, the participants were subjected to hair tests that included measurements of hair length, shortest styled layer length, hair diameter, and HMI with the use of the trichometer. Hair diameter was measured using a standard digital micrometer (0.001mm; Mitutoyo Corp., Kawasaki, Japan). Ten hairs from a distant site on the occipital scalp region were cut (or combed/brushed off by the subject) and their diameters were measured. The highest and lowest readings among the 10 hairs were discarded and the remaining eight hair readings were used to calculate the average diameter. Serial hair breakage assessments were performed on subjects at the same mid-scalp site using the trichometer as previously described.

Subject and product satisfaction questionnaire data were summarized by the treatment group by presenting the mean score (i.e., the higher, the more favorable) across all questions, or for a given category of hair characteristics. No statistical testing was performed on questionnaire data. Study data were analyzed using SAS® software version 9.4 (SAS Institute, Cary, North Carolina).


RESULTS

Subject disposition, demographics, and hair characteristics. Sixty-nine healthy long

haired women who met the entrance criteria were enrolled and randomized into the study. Twelve subjects voluntarily withdrew from the study prior to their first treatment visit (Month 4). A total of 57 women (age range: 19–63 years; mean age: 36.7 years; SD: 10.77 years) with perceptible hair damage completed at least one treatment visit (MFSO, n=24; vehicle, n=17; argan oil, n=16).


All subjects complained of excessive hair damage associated with broken hairs, and a majority (80.7%) claimed to have noticeable hair loss. Twenty-four subjects (42.1%) reported the use of a commercial hair oil product within the previous six months as part of their hair care regimen. All subjects confirmed that they participated in hair care practices that are known to damage hair. Eighty-five percent of subjects reported using at least one of five chemicals (bleach, coloring agent, perm, straightener, and fixative) and one of three physical (rubbing hair to dry, using a hairdryer, and using a hot iron) grooming treatments. Four or more of these eight grooming practices were routinely used by 49.1 percent of the subjects. Subjects with a baseline HHI75 value of less than 2.5 used an average of 3.6 grooming treatments versus an average of 2.9 in subjects with a HHI75 value greater than 2.5. Self-reported adherence to the study product (percentage of diary-logged weeks on which the study hair oil treatment was used) and the continued use of hair grooming modalities that damage hair were uniformly high among all subjects across all three of the treatment groups (>90%). No subject reported any adverse reaction with the use of any of the hair oil treatments that were provided for the study. MFSO components. The content of the NSL fraction within the MFSO was 20.5±1.3g/100g (mean±SD, n=3). Figure 1 shows the TLC analysis from the NSL fraction of the MFSO. Five spots were identified with retardation factor (Rf) values that matched the locations for 1) phytosterols, 2) aliphatic and triterpene alcohols, 3) tocopherols/tocotrienols, 4) carotenes, and 5) squalene and other hydrocarbons. The size of the spots suggested that the three major classes of components were aliphatic/triterpene alcohols, squalene/ hydrocarbons, and phytosterols.


Instrumental hair measurements.

The instrumental hair measurements with calculations for each treatment group at

baseline. There was a homogeneous and representative distribution of all variables among the three treatment groups.

Treatment groups were balanced with respect to baseline hair breakage measurements, ethnicity, hair caliber, hair curvature, hair length, and prior use of hair oils. With respect to the mean percent improvement from baseline at Month 4 and from baseline at Month 8, the MFSO treatment group improved by 103.6 percent and 215.7 percent for the HHI75 and 133.7 percent and 188.3 percent for the HHI50 values, respectively. At both treatment visits, the HHI calculations, expressed as percent change from baseline, were significantly higher (p<0.001) for the MFSO hair oil treatment group as compared with the non-MFSO vehicle and the argan oil brand, thus indicating a much greater ability to increase the levels of unbroken hairs by reducing hair breakage. With respect to the mean percent improvement from baseline at Month 4, from Month 4 to Month 8, and from baseline to Month 8, the MFSO treatment group showed better results than each of the other two treatment groups by at least 117.6 percent (56 percentage points [pp]), 409% (47.4pp), and 234.9 percent (151.3pp) for the HHI75 and 316.5 percent (101.6pp), 165 percent (20.3pp), and 312 percent (142.6 pp) for the HHI50 values, respectively. After four and eight months of treatment, all subjects treated with the MFSO® exhibited an increase in their levels of unbroken hairs from baseline as shown with the calculated HHI values.

Apart from this randomized study, six additional subjects who did not participate in the study, but who had similar entry criteria for the study, were simultaneously followed and assessed with no treatment according to the study timelines. This exploratory analysis was conducted to observe the typical variability in hair health over time. In these six subjects, the changes in hair health indicators and breakage were unremarkable after four and eight months.


Self-assessment.

The MFSO hair oil treatment group had a more favorable response than either of the other treatment groups with respect to the overall improvement in their hair characteristics at Month 4 and month 8, respectively. A total of 15 subjects(26.3%) reported no visible hair loss due to breakage at the completion of the study; this number can be stratified as 10 subjects (41.7%) in the MFSO group, two subjects (11.8%) in the vehicle group and three subjects (18.8%) in the argan oil brand group. At Month 8, the MFSO hair oil treatment group also reported a greater level of satisfaction with the performance of their hair product than did individuals in either of the other treatment groups across all hair categories in the questionnaire.


DISCUSSION

This is the first clinical trial to demonstrate the safety and efficacy of a hair oil containing

MFSO for the treatment of broken hairs in long-haired women with severely damaged

hair. This was also the first randomized, placebo-controlled, double-blind clinical study

that compared the efficacy of a hair oil to its vehicle and a leading brand of commercially available hair oil. In this preliminary study, the group of women that used the MFSO hair oil product at least three times a week on different days for a period of eight months experienced a greater improvement by reducing breakage and increasing their amount of unbroken healthy hairs (HHI as measured by the trichometer) from baseline during treatment and significantly (p<0.001) outperformed subjects using only its vehicle and the argan oil brand. This beneficial result occurred as early as Month 4 and was long-lasting, with continued improvements observed at Month 8, thus achieving the primary and key secondary efficacy endpoints. Furthermore, the self-assessments revealed that a much greater percentage of subjects in the MFSO group reported no visible hair loss due to breakage at the completion of the study as compared with subjects in the vehicle and argan oil brand groups. Subjects also favored the MFSO hair oil treatment on almost all tested attributes, rating it as effective

and aesthetically pleasing, with the majority noting that they would purchase the product.

MFSO has similarities in chemical composition to the oil made by the sebaceo us glands in our scalps and contains lipids that naturally waterproof, lubricate, moisturize, strengthen, protect, and restore hair from Damage. This naturally derived fruit seed oil has only just begun to be clinically tested. Its mechanism of action is likely due to the balanced ratio of saturated/unsaturated fatty acids that imparts a double functionality to protect hair from damage by strengthening hair as a result of its penetration into the shaft and provision of external lubrication to reduce friction and water pickup. MFSO might act to restore hairs from damage by sealing and smoothing the cuticle cracks and other flaws that occur along the damaged hair shaft. Furthermore, MFSO also contains a number of bioactive substances that might play a role in limiting the development and progression of hair damage.

In addition, MFSO also contains among the highest content of the combination of palmitic acid (42%) and squalene (1.5%), two characteristic components found in high amounts in human sebum. Argan oil was chosen as the comparative hair oil treatment due to its popularity in the commercial hair care market. When comparing the amounts of components that might play a role in impacting hair breakage, it was not surprising that MFSO performed better than argan oil since it has a more beneficial profile with a 1) a saturated/ unsaturated free fatty acid ratio of 1:1 versus 1:4, 2) a palmitic acid concentration of 42 versus 12 percent, and 3) a squalene concentration of

1.5 versus 0.3 percent.

Subjects were treated for an extended period of eight months to document evidence of sufficient long-term therapeutic improvement. The results of this study showed that the benefits of using the hair oil treatment containing MFSO were long lasting and incremental. The improvement in hair breakage as evidenced by the beneficial increase in the levels of unbroken hairs (HHI) was seen over 4 to 8 months of treatment in subjects exhibiting high levels of hair breakage who continued using grooming practices that are known to damage hair. In addition, as a group, subjects with very fine hairs with an increased propensity for hair breakage also benefited. These findings are encouraging and indicate that subjects have the potential to reverse hair breakage and normalize their levels of unbroken healthy hairs despite their level of severity, small hair diameter, and the continuation of damaging hair care habits. The degree and speed of HHI normalization could possibly be accelerated if the use of the MFSO is combined with a change in behavior associated with the implementation of healthier grooming practices. Additional studies examining the use of MFSO in women and men with hair damage, the distinct benefits of other hair oils, and the effects of specific grooming practices on hair breakage should be areas of focused research

studies in the future.


CONCLUSION

MFSO is safe and effective for the treatment of women suffering from hair breakage and

damaged hair. MFSO is significantly more effective in reducing hair breakage and in increasing the amounts of unbroken hairs when compared with the use of its vehicle and a leading commercial argan oil brand.


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