Evidence-based products

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carnipure.jpgSTUDY CLAIM: L-carnitine supplementation in pregnancy in sufficient doses avoids a striking increase of plasma-free fatty acids, which are thought to be the main cause of insulin resistance and consequently gestational diabetes mellitus.

PUBLISHED: Lohninger A, et al. Carnitine in pregnancy. Chemical Monthly 2005;136:1523-33.

ABSTRACT: Gestational diabetes affects 5-10 per cent of pregnancies. By the 12th week of gestation, mean whole blood and plasma carnitine levels are already significantly lower than those of controls, with a further significant decrease up to parturition. On delivery, maternal plasma carnitine levels are decreased to about half of the concentrations seen in nonpregnant women.

Diminished carnitine levels may cause a downregulation of carnitine palmitoyltransferase1 (CPT1), both the liver isoform (CPT1A) and muscle isoform (CPT1B), carnitine palmitoyltransferase2 (CPT2), and carnitine acetyltransferase (CRAT) in white blood cells of pregnant women, as determined by real time PCR using the LightCyclerSYBR Green technology.

L-carnitine-L-tartrate supplementation of 2g/day resulted in an up to 10-fold increase of the relative mRNA abundances of CPT1B, CPT2 and OCTN2 and a five-fold increase of CPT1A and CRAT.

There is a relationship between the relative mRNA levels of CPT1A and CPT1B and the free fatty acid plasma levels. The substitution of 2g L-carnitine-L-tartrate=d resulted in significantly lower free fatty acid levels compared to untreated controls and the groups substituted with 0.5g/day and 1g/day Lcarnitine, although plasma carnitine levels were not significantly increased.

The most substantial effect was the reduced portion of acylcarnitines on total carnitine in those women receiving 2g/day L-carnitine-L-tartrate. Carnitine substitution resulted in an enhanced excretion of both free carnitine and acylcarnitines, whereas acetylcarnitine accounts for 50-65 per cent of total acylcarnitines.

Due to its excellent safety profile, LCarnipure supplementation may be appropriate for pregnant women to restore their L-carnitine plasma levels and decrease plasma free fatty acids.

POTENTIAL APPLICATIONS: L-Carnipure tartrate consists of 68 per cent L-carnitine and 32 per cent L-tartaric acid. GRAS and kosher-certified, it is ideal for use in food and drink applications.

MORE INFO: +1 678 445 3535
www.lonza.com

keto.jpgSTUDY CLAIM: A natural metabolite of dehydropeiandrosterone (DHEA), 3-acetyl-7-oxodehydroepiandrosterone (7-oxo DHEA), when combined with a reduced-calorie diet and an exercise program, resulted in a significant weight loss compared with diet and exercise alone.

PUBLISHED:Zenk JL, et al. Effect of lean system 7 on metabolic rate and body composition. Nutrition 2005 Feb; 21(2):179-85.

ABSTRACT: This randomised, double-blind, placebo-controlled clinical trial evaluated whether a commercial weight-loss product (Lean System 7) would result in less reduction in resting metabolic rate (RMR) in overweight subjects on a calorie-restricted diet and exercise regimen than in subjects using diet and exercise alone.

Forty-seven healthy overweight adults were given three capsules of a commercial weight-loss product twice daily or an identical placebo and followed a calorie-restricted diet and an exercise program for eight weeks. At baseline and week eight, researchers measured RMR, body weight, body mass index, waist and hip circumferences, and body composition by dual-energy X-ray absorptiometry.

Of 47 adults enrolled, 35 completed the study. Subjects taking the weight-loss product had a significant increase in RMR, 7.2 per cent increase vs 0.7 per cent decrease in the placebo group. The treatment group also had a significant decrease in hip circumference, 3.78cm vs 2.07cm in placebo. There were no other statistically significant differences in any other outcome variable, diet composition, exercise compliance or adverse events. The product was well tolerated.

In sum, the supplement produced greater weight loss than exercise alone, mostly from fat. It increased metabolism and weight loss without stimulants.

POTENTIAL APPLICATIONS: 7-Keto, an active ingredient in the Lean System 7 formulation, is sold as a dietary supplement under a wide range of labels.

MORE INFO: +1 952 937 7660
www.humaneticscorp.com

ForsLean.jpgSTUDY CLAIM: Sabinsa?s patented Coleus forskohlii extract promotes favourable changes in body composition by significantly increasing lean body mass and decreasing body fat percentages.

PUBLISHED: Godard MP, et al. Body composition and hormonal adaptations associated with forskolin consumption in overweight and obese men. Obes Res 2005 Aug; 13(8):1335-43.

ABSTRACT: This study examined the effect of forskolin on body composition, testosterone, metabolic rate and blood pressure in overweight and obese (BMI 26kg/m2) men. Thirty subjects were studied in a randomised, double-blind, placebo-controlled study for 12 weeks.

Forskolin was shown to elicit favourable changes in body composition by significantly decreasing body fat percentage (BF%) and fat mass (FM) as determined by DXA compared with the placebo group. Additionally, forskolin administration resulted in a change in bone mass for the 12-week trial compared with the placebo group.

There was a trend toward a significant increase for lean body mass in the forskolin group compared with the placebo group. Serum-free testosterone levels were significantly increased in the forskolin group compared with the placebo group. The actual change in serum total testosterone concentration was not significantly different among groups, but it increased 16.77 +- 33.77% in the forskolin group compared with a decrease of 1.08 +- 18.35% in the placebo group.

Oral ingestion of forskolin (250mg of 10% forskolin extract twice a day) for a 12-week period was shown to favourably alter body composition while concurrently increasing bone mass and serum-free testosterone levels in overweight and obese men.

POTENTIAL APPLICATIONS: Forskolin is a possible supplemental therapeutic agent, available in dietary capsules, for the management of obesity.

MORE INFO: +1 732 777 1111
www.forslean.com

sierrasil.jpgSTUDY CLAIM: Patients with osteoarthritis receive fast and effective treatment with SierraSil, a patented mineral complex.

PUBLISHED: Miller MJ, et al. Early relief of osteoarthritis symptoms with a natural mineral supplement and a herbomineral combination: a randomized controlled trial. J Inflamm (Lond) 2005 Oct 21; 2:11.

ABSTRACT: This double-blind, placebo-controlled study was designed to determine if a natural mineral supplement, SierraSil, alone and in combination with a cat?s claw extract (Uncaria guianensis), vincaria, has therapeutic potential in mild to moderate osteoarthritis of the knee. A total of 107 patients with mild to moderate osteoarthritis of the knee were randomly assigned to one of four groups: high-dose SierraSil (3g/day), low-dose SierraSil (2g/day), low-dose SierraSil (2g/day) plus cat?s claw extract (100mg/day), or placebo. The trial was for eight weeks. Primary efficacy variables were WOMAC scores (A, B, C and total). Visual analog score (VAS) for pain, consumption of rescue medication (paracetamol), and tolerability were secondary variables. Safety measures included vital signs and laboratory-based assays.

Ninety-one of the 107 patients successfully completed the protocol. All four groups showed improvement in WOMAC and VAS scores after eight weeks. In all three groups receiving SierraSil, the magnitude of benefits were greater vs placebo (WOMAC total 38-43% vs 27%) but this was not statistically significant. In reference to baseline values, the SierraSil-treated groups had a considerably faster onset of benefits. Placebo-treated individuals failed to show significant benefits at four weeks (11% reduction in total WOMAC).

In contrast, after one or two weeks of therapy, all the SierraSil groups displayed significant reductions in WOMAC scores (p < 0.05) and at week four displayed a 38-43% improvement. VAS was significantly improved at four weeks in all groups, but was significantly greater in all SierraSil groups compared to placebo. Rescue medication use was 28-23% lower in the herbomineral combination and high-dose SierraSil groups, although not statistically different from placebo. Tolerability was good for all groups, no serious adverse events were noted and safety parameters remained unchanged.

The natural mineral supplement, aloneand in combination with a cat?s claw extract, improved joint health and function within one to two weeks of treatment, but significant benefits over placebo were not sustained, possibly due to rescue medication masking.

POTENTIAL APPLICATIONS: SierraSil maybe taken as a dietary supplement.

MORE INFO: +1 888 888 1464
www.sierrasil.com

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