Taste disorders (TDs) are common among systemically treated cancer patients and negatively impact their nutritional status and quality of life. The novel food approved by the European Commission (EFSA), dried miracle berries (DMB), contains the natural taste-modifying protein miraculin. DMB, also available as a supplement, has emerged as a possible alternative treatment for TDs. The present study aimed to evaluate the efficacy and safety of habitual DMB consumption in malnourished cancer patients undergoing active treatment. An exploratory clinical trial was carried out in which 31 cancer patients were randomized into three arms [standard dose of DMB (150 mg DMB/tablet), high dose of DMB (300 mg DMB/tablet) or placebo (300 mg freeze-dried strawberry)] for three months. Patients consumed a DMB tablet or placebo daily before each main meal (breakfast, lunch, and dinner). Throughout the five main visits, electrochemical taste perception, nutritional status, dietary intake, quality of life and the fatty acid profile of erythrocytes were evaluated. Patients consuming a standard dose of DMB exhibited improved taste acuity over time (% change right/left side: -52.8 ± 38.5/-58.7 ± 69.2%) and salty taste perception (2.29 ± 1.25 vs. high dose: 2.17 ± 1.84 vs. placebo: 1.57 ± 1.51 points, p < 0.05). They also had higher energy intake (p = 0.075) and covered better energy expenditure (107 ± 19%). The quality of life evaluated by symptom scales improved in patients receiving the standard dose of DMB (constipation, p = 0.048). The levels of arachidonic (13.1 ± 1.8; 14.0 ± 2.8, 12.0 ± 2.0%; p = 0.004) and docosahexaenoic (4.4 ± 1.7; 4.1 ± 1.0; 3.9 ± 1.6%; p = 0.014) acids in erythrocytes increased over time after DMB intake. The standard dose of DMB increased fat-free mass vs. placebo (47.4 ± 9.3 vs. 44.1 ± 4.7 kg, p = 0.007). Importantly, habitual patients with DMB did not experience any adverse events, and metabolic parameters remained stable and within normal ranges. In conclusion, habitual consumption of a standard 150 mg dose of DMB improves electrochemical food perception, nutritional status (energy intake, fat quantity and quality, fat-free mass), and quality of life in malnourished cancer patients receiving antineoplastic treatment. Additionally, DMB consumption appears to be safe, with no changes in major biochemical parameters associated with health status. Clinical trial registered (NCT05486260).

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.

Miracle fruit (Synsepalum dulcificum) seed oil (MFSO) contains phytochemicals and nutrients reported to affect musculoskeletal performance. The purpose of this study was to assess the safety and efficacy of a compression wristband containing MFSO on its ability to measurably improve the hand and finger motor skills of participants. Healthy right-handed participants (n = 38) were randomized in this double-blind, placebo-controlled study of MFSO and vehicle wristbands. Subjects wore the wristband on their left hand 4-6 weeks and then only on their right hand 2-4 weeks; the contralateral untreated hand served as an additional control. Twelve hand/finger motor skills were measured using quantitative bio-instrumentation tests, and subject self-assessment questionnaires were conducted. With each hand, in 9/12 tests, the MFSO group showed a clinically meaningful average improvement compared with an average worsening in the vehicle group. Statistical superiority to the control treatment group was exhibited in 9/12 tests for each hand (p < .01). After discontinuing the MFSO wristband on the left hand, test values regressed toward baseline levels. Subjects favored the MFSO wristband over the control, rating it as effective in improving their motor skills. Use of the MFSO wristband may improve an individual\'s manual dexterity skills and ability to maintain this performance.