Gilbert R. Kaats

A randomized, double-masked, placebo-controlled study of the effects of chromium picolinate supplementation on body composition : A replication and extension of a previous study

Abstract A previous study using a randomized, double-masked, placebo-controlled design found that supplementation with a minimum of 200 μ;g of chromium (in the form of chromium picolinate [CrP]) per day can lead to significant improvement in body composition (as measured by underwater testing using the displacement method). The present study used a similar design in which 122 subjects were randomized to receive either CrP 400 μ;g (n = 62) or placebo (n = 60). To control caloric intake and expenditure (which was not done in the first study), participants were required to monitor and maintain a log of their daily physical activity and caloric intake. Dual energy x-ray absorptiometry measurements were taken before and after the 90-day period. Analysis of the prestudy data for the two groups revealed no significant differences in any of the initial body composition variables studied. After controlling for differences in caloric intake and expenditure, as compared with the placebo group, subjects in the active treatment group lost significantly more weight (7.79 kg vs 1.81 kg, respectively) and fat mass (7.71 kg vs 1.53 kg, respectively), and had a greater reduction in percent body fat (6.30% vs 1.20%, respectively) without any loss of fat-free mass. A more conservative analysis of covariance revealed similar and statistically significant reductions in percent body fat and fat mass without any loss of fat-free mass. It was concluded that this study replicated earlier findings that supplementation with CrP can lead to significant improvements in body composition.

Evaluating efficacy of a chitosan product using a double-blinded, placebo-controlled protocol

Objective: To examine the safety and efficacy of a chitosan dietary supplement on body composition under free-living conditions. Design: In a randomized, double-blinded, placebo-controlled dietary intervention protocol, subjects were assigned to a treatment group (TRT), a placebo group (PLA) and a control group (CTL). Subjects: A total of 150 overweight adults enrolled; 134 (89.3%) completed the study; 111 (82.8%) were women who were similarly distributed in the three groups. Intervention: The TRT group took six 500 mg chitosan capsules per day and both TRT and PLA groups wore pedometers during their waking hours and recorded daily step totals. The CTL group followed weight loss programs of their choice, and took the same baseline and ending tests. Measures of Outcome: Outcome measures were Dual Energy X-ray Absorptiometry tests, fasting blood chemistries, and self-reported daily activity levels and caloric intakes. Results: Compared to CTL, the TRT group lost more weight (−2.8 lbs vs. +0.8 lbs, p < 0.001) and fat mass (−2.6 lbs vs. +0.1 lbs, p = 0.006). Compared to PLA, the TRT group lost more weight (−2.8 lbs. vs. −0.6 lbs, p = 0.03), % fat (−0.8% vs. +0.4%, p = 0.003), fat mass (−2.6 lbs vs. +0.6 lbs, p = 0.001) and had a greater body composition improvement index (BCI) (+2.4 lbs vs. −1.9 lbs, p = 0.002). Conclusions: These data provide evidence for the efficacy of a chitosan compound to facilitate the depletion of excess body fat under free-living conditions with minimal loss of fat-free or lean body mass.

A Review of the Efficacy and Safety of Banaba (Lagerstroemia speciosa L.) and Corosolic Acid

Banaba (Lagerstroemia speciosa L.) extracts have been used for many years in folk medicine to treat diabetes, with the first published research study being reported in 1940. This review summarizes the current literature regarding banaba and its constituents. The hypoglycemic effects of banaba have been attributed to both corosolic acid as well as ellagitannins. Studies have been conducted in various animal models, human subjects and in vitro systems using water soluble banaba leaf extracts, corosolic acid‐standardized extracts, and purified corosolic acid and ellagitannins. Pure corosolic acid has been reported to decrease blood sugar levels within 60 min in human subjects. Corosolic acid also exhibits antihyperlipidemic, antioxidant, antiinflammatory, antifungal, antiviral, antineoplastic and osteoblastic activities. The beneficial effects of banaba and corosolic acid with respect to various aspects of glucose and lipid metabolism appear to involve multiple mechanisms, including enhanced cellular uptake of glucose, impaired hydrolysis of sucrose and starches, decreased gluconeogenesis and the regulation of lipid metabolism. These effects may be mediated by PPAR, MAP K, NF‐κB and other signal transduction factors. No adverse effects have been observed or reported in animal studies or controlled human clinical trials. Banaba extract, corosolic acid and other constituents may be beneficial in addressing the symptoms associated with metabolic syndrome, as well as offering other health benefits. Copyright

A 60day double-blind, placebo-controlled safety study involving Citrus aurantium (bitter orange) extract.

Bitter orange (Citrus aurantium) extract and its primary protoalkaloid p-synephrine are widely consumed in dietary supplements for weight management and sports performance. p-Synephrine is also present in foods derived from a variety of Citrus species. Bitter orange extract is commonly used in combination with multiple herbal ingredients. Most clinical studies conducted on bitter orange extract alone have involved single doses. The purpose of this study was to assess the safety of bitter orange extract (approximately 49mg p-synephrine) alone or in combination with naringin and hesperidin twice daily given to 25 healthy subjects per group for 60days in a double-blinded, placebo-controlled protocol. No significant changes occurred in systolic or diastolic blood pressures, blood chemistries or blood cell counts in control or p-synephrine treated groups. Small, clinically insignificant differences in heart rates were observed between the p-synephrine plus naringin and hesperidin group and the p-synephrine alone as well as the placebo group. No adverse effects were reported in the three groups. Bitter orange extract and p-synephrine appear to be without adverse effects at a dose of up to 98mg daily for 60days based on the parameters measured.

A combination of l-arabinose and chromium lowers circulating glucose and insulin levels after an acute oral sucrose challenge

BackgroundA growing body of research suggests that elevated circulating levels of glucose and insulin accelerate risk factors for a wide range of disorders. Low-risk interventions that could suppress glucose without raising insulin levels could offer significant long-term health benefits.MethodsTo address this issue, we conducted two sequential studies, the first with two phases. In the first phase of Study 1, baseline fasting blood glucose was measured in 20 subjects who consumed 70 grams of sucrose in water and subsequently completed capillary glucose measurements at 30, 45, 60 and 90 minutes (Control). On day-2 the same procedure was followed, but with subjects simultaneously consuming a novel formula containing l-arabinose and a trivalent patented food source of chromium (LA-Cr) (Treatment). The presence or absence of the LA-Cr was blinded to the subjects and testing technician. Comparisons of changes from baseline were made between Control and Treatment periods. In the second phase of Study 1, 10 subjects selected from the original 20 competed baseline measures of body composition (DXA), a 43-blood chemistry panel and a Quality of Life Inventory. These subjects subsequently took LA-Cr daily for 4 weeks completing daily tracking forms and repeating the baseline capillary tests at the end of each of the four weeks. In Study 2, the same procedures used in the first phase were repeated for 50 subjects, but with added circulating insulin measurements at 30 and 60 minutes from baseline.ResultsIn both studies, as compared to Control, the Treatment group had significantly lower glucose responses for all four testing times (AUC = P < 0.0001). Additionally, the Treatment was significantly more effective in lowering circulating insulin after 60 minutes from baseline (AUC = P = < 0.01). No adverse effects were found after acute sucrose challenge or in those who consumed LA-Cr daily for four weeks.ConclusionsAs compared to a placebo control, consumption of a LA-Cr formula after a 70-gram sucrose challenge was effective in safely lowering both circulating glucose and insulin levels.Trial RegistrationClinical Trials.gov, NCT0110743

β-Carotene and α-tocopherol in healthy overweight adults; depletion kinetics are correlated with adiposity

Healthy overweight subjects (24 males, 68 females; mean age=48.8 years; body mass index=27.1±4.9) participated in a randomized, double-blind, placebo-controlled crossover study with two periods of 28-day supplementation using a nutritional product composed primarily of dehydrated juice concentrates from mixed fruits and vegetables (JuicePlus +®). Compared with placebo, supplementation for 28 days increased concentrations of serum β-carotene by 264% (P <0.001) and α-tocopherol by 14% (P < 0.01). After crossover of the active group to placebo, β-carotene and α-tocopherol declined via first-order kinetics, with serum half-lives (t1/2) for β-carotene and α-tocopherol determined to be 22.8±3.1 and 4.6±2.3 days, respectively. Depletion rates for β-carotene correlated with adiposity (quartile 1, body mass index=21.96, t1/2=17.6 days vs. quartile 4, body mass index=37.87, t1/2=26.3 days; P < 0.05). In conclusion, the supplementation period resulted in significantly elevated levels of β-carotene and α-tocopherol, indicating bioavailability. These increased levels persisted 2–4 weeks after supplementation was discontinued, and the rates of depletion were correlated with the levels of general adiposity.

Comparative Effectiveness Research (CER): Opportunities and Challenges for the Nutritional Industry

Emerging interest in CER. An important current trend in medical research is the emerging interest in Comparative Effectiveness Research (CER), driven at least in part by the US government’s 2009 decision to allocate

Increased eating control and energy levels associated with consumption of bitter orange ( p -synephrine) extract: a randomized placebo-controlled study

1.1 billion to support such research. Major medical journals have responded with numerous CER articles, but to date the nutritional community has been largely silent. However CER will be an important issue for the nutritional industry as well, and brings with it both challenges and opportunities. What is CER? CER is typically defined as the generation and synthesis of evidence comparing the benefits and risks of different interventions for preventing, diagnosing, treating, and monitoring health conditions under real-world patient conditions that typically confront physicians [1-2]. The American College of Physicians [3] and The Congressional Budget Office [4] suggest the definition of CER should also include comparing the costs of different interventions. CER shares some of the same characteristics of practical clinical trials where real world conditions are used to compare treatment choices that practitioners face in patients drawn from their practice, which allows the practitioner to decide between treatment options [5]. CER Distinguished From Placebo Trials. CER is a marked departure from the efficacy and safety research typically used by the FDA to approve medications and devices. The key point is that current research tends to be focused on whether the new medication or device is safe and effective, not on whether the new medication or device is safer or more effective than the interventions already in common use. Approval is often granted based on relatively small studies conducted over relatively short periods under conditions unrepresentative of those encountered in daily practice. Typically the only efficacy standard is that the new intervention outperforms placebo or randomized control groups [6]. Thus, new interventions can be approved irrespective of whether they represent actual improvements in cost, safety, and efficacy over existing interventions. However, as Woolf has recently pointed out ‘‘...randomized trials are seldom designed to answer practical questions about the relative benefits and harms of one treatment as compared to another for a particular patient’’. This informational vacuum can lead to approval of a number of ‘‘me too’’ interventions that rely on ‘‘Vigorous marketing of the costliest new approaches . . .encouraging the widespread use of goods or services that may be no better, less safe, or more costly than usual care – or all of the above’’ [6]. Absent CER studies, there is no systematic way to give healthcare providers comparative data that goes beyond marketing efforts. Government Support for CER. CER was discussed in the US Congressional Budget Office’s 2007 report. However, interest in CER increased dramatically when the stimulus package was signed into law by President Obama on February 17, 2009. It directed

General Lack of Correlations between Age and Signs of the Metabolic Syndrome in Subjects with Non-diabetic Fasting Glucose Values

1.1 billion to support ‘‘the development and dissemination of research assessing the comparative effectiveness of health care treatments and strategies, including efforts to conduct research that compares the effectiveness of services used to prevent, diagnose, or treat diseases, disorders, and other health conditions’’ [7]. Clearly the Obama administration views CER as an important strategy for reforming the nation’s healthcare system and expects CER to lead to improved quality and affordability of medical interventions [8]. Government Priorities. Congress has directed the Department of Health and Human Services (DHHS) to consider a list of broad-based priorities as it implements the CER agenda. DHHS has already received input from the Institute of Medicine (IOM), and will also receive input from a newly created Federal Coordinating Council for Comparative Effectiveness Research [9]. The important point to note is that, although CER itself is simply a tool and as such is apolitical, the process of allocating

Safety and Efficacy of Banaba–Moringa oleifera–Green Coffee Bean Extracts and Vitamin D3 in a Sustained Release Weight Management Supplement

1.1 billion necessarily involves prioritization and as such will always have a political component. Opposition to CER. The emphasis on CER in the stimulus package was met with a vigorous and well-coordinated backlash, particularly centered on the incorporation of cost comparisons as a basic component of CER studies. Dissenters argued that this would inevitably lead to government domination of the doctor-patient relationship, ‘‘cookbook medicine’’ and ultimately the rationing of healthcare services