A parallel, double-blind, bioavailability study was conducted with 28 healthy male and female volunteers over 18 years old to measure uptake of Levagen®+ (PEA) over a 24-hour period. The objective of this trial was to determine whether the use of a lipid-based drug delivery system, LipiSperse®, can be successfully used to improve the bioavailability of Levagen®.
The results indicate that by combining Levagen with LipiSperse® delivery system, PEA absorption is more effective.
Double-blinded, randomized, placebo-controlled 8-week study to assess the safety and efficacy of Levagen® on patients with mild to moderate osteoarthritis. The clinical trial studied 120 patients:
(i) Placebo [40]; (ii) Levagen® 300mg/day [40]; and Levagen® 600mg/day [40].
300mg and 600mg Levagen® significantly:
Palmitoylethanolamide is both a powerful anti-inflammatory and pain reliever, providing an all-in-one solution for managing discomfort.*
A double-blind, randomised, placebo-controlled study to evaluate the effect of orally dosed Levagen®+ on exercise recovery in 28 healthy males (18-35 years).
72-hour treatment duration with 2 trial arms: (i) Levagen+ 168mg; and (ii) Placebo
30 minutes after ingestion of product, participants were exercised to induce local leg muscle fatigue using a leg press (4 sets of 80% of 1RM). Participants consumed the supplement again post-workout and dosed once daily for three days thereafter.
Two hours post exercise fatigue the participant again completed 1 set of leg press reps at 70% of maximal until exhaustion to measure performance.
Levagen®+ significantly:
The results suggest that Levagen®+ may allow individuals to train harder and longer than placebo by reducing muscle damage and sparing anaerobic energy metabolism. This allows athletes to push past their limits and improve training response.
A 2-week double-blind, randomised, placebo-controlled trial to evaluate the effect of Levagen®+ on 80 male and female participants.
350mg Levagen®+ significantly:
This study demonstrates PEA’s fast onset of action in supporting the reduction of joint pain discomfort after Day 3.
A double-blind, randomised controlled study to evaluate the effectiveness of Levagen®+ compared to ibuprofen for headache discomfort and duration support.
These results may support use of Levagen®+ as a safe and effective alternative to treatments used for headaches.
A 8-week double-blind, randomised, placebo-controlled trial to evaluate the effect of Levagen®+ on sleep quality and quantity.
These results may support use of Levagen®+ as a safe and effective alternative to treatments used for headaches.
Levagen®+ was clinically researched to signifiicantly reduce VAS scores and resolved migraines classified as moderate when compared to placebo
Figure 2. (A) Total VAS score over the first 4 h and (B) change in VAS score over the first 4 h. a= significant difference from the baseline in the Levagen®+ group (p < 0.05); b = significant difference from the baseline in the placebo group (p < 0.05); *=significant difference between groups (p < 0.05).
In a brand new study, Levagen®+ efficacy was studied at 700mg or a matching placebo for 6 weeks in a double armed, cross-over trail.
Levagen®+ supported significant improvement in serum BDNF levels when compared to placebo and helped to improve memory through better first success and fewer errors.
The recently published topical study showed the efficacy of Levagen®+ in a topical formulation applied twice daily for 4 weeks.
Levagen®+ supported a significant reduction in skin dryness, skin redness, and reduced a total POEM score compared to a comparator cream.
A double-blind, randomised, placebo-controlled study to evaluate the effect of orally dosed Hydrocurc® on exercise recovery in 28 healthy males (18-35 years).
72-hour treatment duration with 2 trial arms: (i) Hydrocurc® 500mg; and (ii) Placebo.
30 minutes after ingestion of product, participants were exercised to induce local leg muscle fatigue using a leg press (4 sets of 80% of 1RM). Participants consumed the supplement again post-workout and dosed once daily for three days thereafter.
Two hours post exercise fatigue the participant again completed 1 set of leg press reps at 70% of maximal until exhaustion to measure performance.
500mg Hydrocurc® significantly:
These results suggest that Hydrocurc® may allow for a quicker return to exercise training or ability to exercise higher thresholds. This may be due to an interaction between IL-6 and IL-10 eliciting anti-inflammatory properties which reduce thigh circumference, pain, and modulate energy metabolism.
Activation of mTOR pathway also indicates Hydrocurc® to be a potential stimulator of muscle hypertrophy.
A 6-week double-blind, randomised, placebo-controlled study to study the effects of co-administering oral iron supplementation with HydroCurc® on serum BDNF levels and ferritin levels.
* >50mg iron = pharmaceutical dose
HydroCurc® +18mg Iron group had:
These results indicate that co-administrating HydroCurc® with 18 mg elemental iron for 42 days can significantly increase serum BDNF levels and ferritin levels, which may suggest the ability to enhance cognitive function (memory & learning) and tolerance to iron supplementation.
A parallel, double-blind, bioavailability study was conducted with 28 healthy male and female volunteers over 18 years old to measure uptake of Hydrocurc® PEA over a 24-hour period. The objective of this trial was to determine whether the use of a lipid-based drug delivery system, LipiSperse®, can be successfully used to improve the bioavailability of Curcuma longa extract (95% curcuminoids).
These results indicate Hydrocurc® to be the most bioavailable curcumin seen in industry to date with the lowest dose.
Hydrocurc® also had the highest loading of Curcuma longa extract (90%) with the lowest load of excipients (10% Lipisperse®).
12-week double-blind, randomized, placebo-controlled study to assess the effectiveness of Testofen® on 20 male subjects (aged 40-75) with symptoms of andropause (male menopause).
Participants were given a clinically validated questionnaire (AMS), which was comprised of seventeen questions in three sub-scales (Psychological, Somatic, and Sexual). This questionnaire helped gauge the level of severity of Andropause symptoms. In addition, this study also used the DISF-SR to measure the parameters.
600mg Testofen® significantly:
This study suggests Testofen® to be a safe and effective treatment for reducing symptoms of possible androgen deficiency, improve sexual function and increase serum testosterone in healthy middle-aged and older men.
An 8-week double-blind, randomized, placebo-controlled study to evaluate the effect of Testofen® on muscle strength, aerobic endurance and body composition in 138 healthy exercising males.
Muscle strength (1RM leg and bench press) and muscular endurance (80% of 1RM bench and leg press until fatigue) were measured.
Body composition and functional threshold power (FTP) were also measured.
Three groups: (i) 600mg Testofen®; (ii) 300mg Testofen®; (iii) Placebo
Dose-dependent improvement in lower body strength across all three groups.
600mg Testofen® significantly:
Testofen® at a 600 mg/day dose in conjunction with an effective exercise regime has superior positive effects in leg strength, aerobic capacity and body composition compared with placebo and a 300 mg/day dose. Testofen® may be an effective ergogenic aid for those wanting to rapidly improve their exercise performance capabilities and body composition above and beyond that of only exercise training.
A six-week double-blind, randomized, placebo-controlled clinical study to assess the efficacy of Testofen® on enhancing libido in 60 healthy adult males (aged 25-52).
DISF-SR was administered to measure quality of sexual functioning, along with QOL measures.
600mg Testofen® significantly:
This study suggests that 600mg Testofen® can improve physiological aspects of libido and may assist to maintain normal healthy testosterone levels.
A double-blind, randomized, placebo-controlled human clinical study to assess the efficacy and safety of Testofen® on physiological parameters related to muscle anabolism, androgenic hormones, and body fat in 60 male subjects during an 8-week resistance training program.
600mg Testofen® significantly:
This study suggests Testofen® to provide anabolic and androgenic activity in resistance trained male subjects by improving body fat without a reducing muscle strength or repetitions to failure. Testofen® was also found to be safe and well-tolerated.
affron® the top saffron ingredient worldwide (most researched and studied) balances mood and promotes restorative sleep in healthy adults over 4 weeks in a double-blind, parallel, randomized, placebo controlled clinical trial. First clinical study performed with a commercial saffron extract in healthy people.
The participants, self-reporting low mood, were included, and randomly assigned to groups: (i) affron® 22mg; (ii) affron® 28 mg; (iii) placebo.
28mg/day affron®:
These results indicate affron® to be a safe and effective ingredient to help support mood and sleep. This opens up new horizons in promising natural therapies.
A single dose, randomized, double blinded study was used to evaluate the bioavailability (of crocins) of two different saffron doses (56 mg and 84 mg).
affron® galenic presentation showed rapid absorption and high oral bioavailability.
A randomised, double-blind, placebo-controlled study to investigate the efficacy of 28mg/day affron® for encouraging a positive mood, occasional stress, and sleep quality in 128 healthy adults over 4 weeks.
A 4-week randomized, double-blind, placebo-controlled study to examine the sleep-enhancing effects of 28mg/day affron® in 63 adults aged between 18 and 70 years (average age 50 years) with self-reported sleep problems.
A 60-day, double-blind, randomized placebo-controlled clinical trial to assess the effect of Slimaluma® on appetite, food intake and body composition in 50 overweight male and females (25-60 years).
1g Slimaluma® significantly:
There was also trend towards a greater decrease in body weight, body mass index, hip circumference, body fat and energy intake between assessment time points in the experimental group, although not different between experimental and placebo groups.
These results indicate Slimaluma® to suppress appetite, and reduce waist circumference when compared to placebo over a 2 month period.
A 12-week randomised, placebo-controlled study to assess the effect of Slimaluma® on risk factors of metabolic syndrome in metabolic 43 obese and overweight subjects.
1g Slimaluma® significantly:
In addition a significant reduction in bodyweight, BMI, hip circumference, systolic BP, HR, triglyceride levels, total fat and saturated fat intake within both groups.
This suggests that supplementing with Slimaluma® whilst controlling overall dietary intake and physical activity may potentially play a role in curbing central obesity, the key component of metabolic syndrome.
An 8-week randomized placebo-controlled clinical trial on the efficacy of Slimaluma® for reducing anxiety and stress in 97 healthy adults with mild-moderate anxiety.
1g Slimaluma® significantly:
The findings indicate that Slimaluma® is superior to placebo in reducing subclinical anxiety and stress over 8 weeks.
A 12-week double-blind, randomised, placebo-controlled study to assess the effect of Libifem® in reducing menopausal symptoms in 115 women (aged 40-65).
Primary outcome measure: Reduction in menopausal symptoms (MENQOL).
Secondary outcome measures: Serum sex hormone levels and other quality of life questionnaires – DISF and FSFI (sexual function), PSI (sleep function), and IPAC (physical exercise).
600mg Libifem® significantly:
The average estradiol levels were similar in both the active group and placebo group after treatment.
This study demonstrated that Libifem® may reduce menopausal symptoms in healthy women.
An 8-week double-blind, randomised, placebo-controlled study to evaluate the effect of Libifem® on sex hormones and sexual function in 80 healthy menstruating women (aged 20-49) who reported low sexual drive.
Sexual function was measured using the DISF-SR standard, which tests five domains of sexual function.
600mg Libifem® significantly:
The results indicate that Libifem® may be auseful treatment for increasing sexual arousal and desire in women.
An 8-week double-blind, randomised, two active, placebo-controlled trial to evaluate the effect of Libifem® on 129 women aged 25 to 45 years of age.
300mg and 600mg Libifem® significantly:
The results indicate that Libifem® may be auseful treatment for increasing sexual arousal and desire in women.
Rao A., Calyton P., (2023). Frontiers in Sports and Active. 5.
A 12-week double-blind, randomized, placebo-controlled trial to examine the safety and efficacy of Genopause® in reducing vasomotor and other menopause-associated symptoms in 117 healthy women (aged 40-65).
1g Genopause® significantly:
There were no significant changes observed in serum hormone levels or health indices between the active and the placebo group.
This study demonstrated Genopause® to be a safe and effective treatment for reducing menopausal symptoms in healthy menopausal women over a duration of 12 weeks.
A 12-week double‐blind, randomized, placebo‐controlled clinical trial assessed the efficacy and safety of AGEprost™ in treating 109 men (aged 41-79) with benign prostatic hypertrophy (BPH).
250mg AGEprost™ significantly:
Overall, steroid hormones, SHBG, PSA levels, DHEA and Cortisol remained within the healthy reference range in both groups and remained stable over the 12 weeks. There were no changes in associated age-related symptoms and sexual function in either group. Treatment was well tolerated and there were no serious adverse effects observed during the study period.
The overall results indicate that AGEprost™ may be an effective treatment for reducing symptoms of BPH in healthy men, in part, through inhibition of 5‐alpha‐reductase enzyme activity.
A double‐blind, randomised, placebo‐controlled study.
450mg ActivAMP® significantly:
This study revealed that Gynostemma pentaphyllum supplementation for 16 weeks reduced body weight and fat mass in overweight and obese males and females. Visceral fat reduction was observed in the male subgroup.
This study demonstrated that ActivAMP® significantly supports an increase in VO2 max in comparison to the placebo, indicating that ActivAMP® supports aerobic fitness.
450mg ActivAMP® significantly:
A 60-day double-blind, placebo-controlled, randomised trial to assess the efficacy and safety of Coccinia indica in 60 incident type 2 diabetic subjects (aged 35-60).
1g Gencinia® significantly:
This study suggests that Coccinia cordifolia extract has a potential hypoglycemic action in patients with mild diabetes.
An eight-week double-blind, randomized placebo controlled clinical trial was conducted using CALMaluma™ on 97 patients (49 in the active group and 48 in the placebo group).
The study showed statistically significant results in the active group when compared to the placebo for:
An in-vivo animal study showed CALMaluma™ also facilitates learning and supports memory function. The study also revealed a reduction in anxiousness in test animals. CALMaluma™ therefore exhibited both Nootropic and Anxiolytic activity in animal models.
Effect of A. conyzoides on 5α-reductase gene expression in Human Hair Dermal Papilla Cells (HHDPC) after 48h treatment.
After 48 hours of treatment, there was a significant reduction (3-fold reduction) in 5α-reductase type 1 mRNA expression in the 0.1 mg A. conyzoides group compared to negative control.
Effect of A. conyzoides on inhibition of PGD2 production in Human Hair Dermal Papilla Cells (HHDPC) after 6 h treatment
After 6 hours of treatment, there was a significant inhibition of PGD2 release in HHDPC in A. conyzoides groups compared to negative control.
A. Conyzoides inhibits 5α-reductase → prevents conversion of testosterone to DHT → improved hair growth and decreased hair loss
A. Conyzoides inhibits PGD2 → improved hair growth and decreased hair loss
Temporal recession in men reduced:
In Men:
There was a dose-dependent increase in proportion of participants who:
In Women:
The majority of participants:
All participants self-reported an improvement in their hair loss symptoms
Our study found a significant increase in hair density and significant decrease in HLR following topical application of A. conyzoides. At 12-weeks, hair density in the A. conyzoides treated group was significantly higher and HLR was significantly lower than the placebo group. No significant changes were found in the one-minute combing test or hair pull test or assessment by the Hamilton-Norwood and Savin hair loss scales. QoL measures and biochemical and haematological parameters showed no significant changes throughout the study.
The results from our study demonstrate a net increase in hair growth following topical application of A. conyzoides.
Randomized, Double-blind, Placebo and Active comparator-controlled study, to evaluate the efficacy of a novel herbal composition to improve Liver function and well-being of non-alcoholic subjects with elevated Fatty Liver Index.
Test materials:
One capsule of 300 mg 4Liver (CL16049F1) per day after dinner, 320 mg active comparator, or placebo for 12 weeks.
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* These statements have not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure, or prevent any disease.
These statements have not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure, or prevent any disease.
