Effect of Calcium Derived from Lithothamnion sp. on Markers of Calcium Metabolism in Premenopausal Women.

A double-blind crossover pilot trial tested the hypothesis that botanically derived calcium could demonstrate greater influence over calcium metabolism markers compared with a nonplant-derived calcium carbonate supplement or placebo. Twelve fasting female subjects received a single oral dose of Aquamin F™ (derived from the marine algal Lithothamnion sp.), or calcium carbonate, or placebo. Blood and urine samples were collected at baseline and over 12 h to evaluate ionized and total calcium and parathyroid hormone (PTH). Subjects treated with Aquamin F demonstrated significantly greater urinary clearance of calcium after 12 h compared with placebo (P = .004). Following a meal at 90 min, subjects treated with Aquamin F demonstrated a more prolonged suppression of serum PTH concentration (significantly lower than placebo at 90, 120, and 240 min). Calcium carbonate provided an intermediate response; urinary clearance was not significantly different from placebo treatment and PTH was only significantly lower than placebo at 90 min. Aquamin F may demonstrate greater influence over these markers of calcium metabolism than calcium carbonate or placebo, as suggested by a greater calciuric response and a more prolonged suppression of serum PTH concentrations following a meal in premenopausal women.

GRAS from the ground up: Review of the Interim Pilot Program for GRAS notification.

After publication of the draft Generally Regarded As Safe (GRAS) rule in 1997, the United States (US) Food and Drug Administration (FDA) initiated an Interim Pilot Program encouraging the notification to FDA of GRAS determinations. This paper analyzes GRAS notifications submitted during the Interim Pilot Program along with warning letters issued during the same time period to better understand the evolution of the program and anticipate the future GRAS landscape. The success of the GRAS Notification program is demonstrated by the increasing rate of GRAS Notifications submitted to the FDA during the Interim Pilot Program, as well as the shift from a primarily domestic process to a process featuring an equal to greater contribution of GRAS Notifications from companies outside the US. Analysis of the first 600 GRAS Notifications revealed a number of interesting trends regarding the inclusion and composition of GRAS Expert Panels; differences in notifications for substances with nutritive, processing aid, or effect; and the duration of GRAS Notifications. The review of FDA warning letters associated with GRAS issues provides additional insight into GRAS notices, from the perspective of ongoing post-market emphasis on food safety with the implementation of the GRAS Final Rule.

Meal Replacement Beverage Twice a Day in Overweight and Obese Adults (MDRC2012-001).

This open label, single arm, prospective, interventional, weight loss trial evaluated a meal replacement beverage (Right Size(®) Smoothie) used to replace breakfast and lunch each day for 12 weeks (7 clinic visits) as part of a calorie-restricted diet in overweight and obese adults. A total of 155 individuals were screened, 55 enrolled and 28 completed this 12 week study. Subjects were obese (mean weight: 206 pounds and BMI: 32.7 kg/m(2)) and the mean age was 40 years including 42 (76.4%) female and 13 (23.6%) male volunteers. The modified Intent to Treat and Completer groups lost an average of 10.6 and 13.8 pounds and reduced their average BMI by 1.7 and 2.2 kg/m(2) respectively during this 12 week trial. The Per Protocol group lost 15.2 pounds and 2.4 kg/m(2) and the Optimal Weight Loss group lost 18.5 pounds and 2.9 kg/m(2). Using the Satiety Labeled Intensity Magnitude scale (SLIM) questionnaire, subjects reported feeling relatively hungry before they consumed the beverage, then feeling relatively full 15 minutes following the beverage with the sensation of some fullness lasting more than 2 hours and then feeling relatively hungry again at 3 hours after consuming the beverage. Study subjects reported significant improvements in physical functioning, general health, vitality and mental health as well as increased cognitive restraint of eating, reduced disinhibition and reduced hunger during the trial. The study beverages were well tolerated and no Serious Adverse Events (SAE) reported. This study suggests the study beverage aids in weight loss by helping to curb hunger during a reduced calorie diet program.

Reduced viscosity Barley ß-Glucan versus placebo: a randomized controlled trial of the effects on insulin sensitivity for individuals at risk for diabetes mellitus.

BACKGROUND: Prior studies suggest soluble fibers may favorably affect glucose/insulin metabolism. METHODS: This prospective, randomized, placebo controlled, double blind, parallel group trial evaluated 50 generally healthy subjects without prior diagnosis of diabetes mellitus (44 completers), who were administered beverages containing placebo (control), lower dose (3 g/d), or higher dose (6 g/d) reduced viscosity barley ß-glucan (BBG) extract. Subjects (68% women) mean age 56 years, Body Mass Index (BMI) 32 kg/m2 and baseline fasting plasma glucose 102 mg/dl were instructed to follow a weight-maintaining Therapeutic Lifestyle Changes (TLC) diet and consumed three 11 oz study beverages daily with meals for 12 weeks. The four primary study endpoint measures were plasma glucose and insulin [each fasting and post-Oral Glucose Tolerance Testing (OGTT)]. RESULTS: Compared to placebo, administration of 3 g/d BBG over 12 weeks significantly reduced glucose incremental Area Under the Curve (iAUC) measures during OGTT and 6 g/d BBG over 12 weeks significantly reduced fasting insulin as well as the related homeostasis model assessment of insulin resistance (HOMA-IR). Beverages were generally well tolerated with no serious adverse experiences and no significant differences between groups for adverse experiences. Per protocol instruction, subjects maintained body weight. CONCLUSIONS: These findings suggest 6 g/d BBG consumed in a beverage over 12 weeks may improve insulin sensitivity among hyperglycemic individuals with no prior diagnosis of diabetes mellitus, and who experience no change in body weight. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT01375803.

A novel liquid multi-phytonutrient supplement demonstrates DNA-protective effects.

This study explored the DNA protective (anti-mutagenic) effects of an oral, liquid, multi-phytonutrient dietary supplement containing a proprietary blend of fruits, vegetables and aloe vera concentrated components in addition to a proprietary catechin complex from green tea (VIBE Cardiac & Life, Eniva Nutraceuticals, Anoka, MN; herein described as "VIBE"). This study tested the hypothesis that VIBE would reduce DNA damage in skin cells exposed to UVR. Human epidermal cells, from the cell line A431NS, were treated with 0% (control), 0.125%, 0.5%, 1% and 2% VIBE, and then exposed to 240 J/m(2) UVR. The amount of DNA damage was assessed using the COMET assay. At each concentration tested, a significantly smaller amount of DNA damage was measured by the COMET assay for the VIBE treated cells compared to the control cells exposed to UVR without VIBE. The dose response curves showed a maximal response at 0.5% VIBE with a threefold reduction in COMET tail density compared to the control samples without VIBE (p < 0.001). Additional research is warranted in human clinical trials to further explore the results of this study which demonstrated the DNA protective and anti-mutagenic effects of VIBE for human skin cells exposed to UVR-induced DNA damage.

A natural seaweed derived mineral supplement (Aquamin F) for knee osteoarthritis: a randomised, placebo controlled pilot study.

BACKGROUND: Osteoarthritis (OA) is a slowly destructive process that may be influenced by a nutritional mineral balance in the body. METHODS: This small, double blind, placebo controlled pilot study investigated the impact of treatment with a natural multi-mineral supplement from seaweed (Aquamin) on 6 minute walking distance (6 MWD), range of motion (ROM), and pain and joint mobility measured by the Western Ontario and McMaster Universities (WOMAC) Osteoarthritis Index in subjects with moderate to severe OA of the knee during gradual withdrawal of non-steroidal anti-inflammatory drugs (NSAIDs) that were being used daily for pain management. Subjects (n = 29) with moderate to severe OA of the knee were randomised to receive either Aquamin (2400 mg/d) or Placebo for up to 12 weeks. RESULTS: Of the 29 subjects initially randomized, only 22 subjects proceeded to treatment due to 7 subjects not meeting study selection criteria at baseline. Fourteen subjects completed the study and an ITT analysis (n = 22) of the data showed no significant differences in WOMAC scores however, the data did reveal significant improvements in passive and active extension ROM (0.83 degrees +/- 1.54 vs. -1.54 degrees +/- 2.43; difference, 5.2 degrees +/- 2.2, p = 0.028) and 6 MWD (150 +/- 48 ft vs. 12.5 +/- 31.5 ft; difference, 136 +/- 57 ft, p = 0.03) in the Aquamin group compared to the placebo group; respectively, following a 50% reduction in NSAID use. The treatments were well tolerated and the adverse event profiles were not significantly different between the groups. CONCLUSION: This small preliminary study suggests Aquamin may increase range of motion and walking distances in subjects with OA of the knee and may allow partial withdrawal of NSAIDs over 12 weeks of treatment. Additional research is needed to confirm these preliminary observations. TRIAL REGISTRATION: NCT00755482.

A whey-protein supplement increases fat loss and spares lean muscle in obese subjects: a randomized human clinical study.

BACKGROUND: This study evaluated a specialized whey fraction (Prolibratrade mark, high in leucine, bioactive peptides and milk calcium) for use as a dietary supplement to enhance weight loss. METHODS: This was a randomized, double-blind, parallel-arm, 12-week study. Caloric intake was reduced 500 calories per day. Subjects consumed Prolibra or an isocaloric ready-to-mix beverage 20 minutes before breakfast and 20 minutes before dinner. Body fat and lean muscle tissue were measured by dual-energy x-ray absorptiometry (DEXA). Body weight and anthropometric measurements were recorded every 4 weeks. Blood samples were taken at the beginning and end of the study. Statistical analyses were performed on all subjects that completed (completer analysis) and all subjects that lost at least 2.25 kg of body weight (responder analysis). Within group significance was determined at P < 0.05 using a two-tailed paired t-test and between group significance was determined using one way analysis of covariance with baseline data as a covariate. RESULTS: Both groups lost a significant amount of weight and the Prolibra group tended to lose more weight than the control group; however the amount of weight loss was not significantly different between groups after 12 weeks. Prolibra subjects lost significantly more body fat compared to control subjects for both the completer (2.81 vs. 1.62 kg P = 0.03) and responder (3.63 vs. 2.11 kg, P = 0.01) groups. Prolibra subjects lost significantly less lean muscle mass in the responder group (1.07 vs. 2.41 kg, P = 0.02). The ratio of fat to lean loss (kg fat lost/kg lean lost) was much larger for Prolibra subjects for both completer (3.75 vs. 1.05) and responder (3.39 vs. 0.88) groups. CONCLUSION: Subjects in both the control and treatment group lost a significant amount of weight with a 500 calorie reduced diet. Subjects taking Prolibra lost significantly more body fat and showed a greater preservation of lean muscle compared to subjects consuming the control beverage. Because subjects taking Prolibra lost 6.1% of their body fat mass, and because a 5% reduction of body fat mass has been shown to reduce the risk of obesity related disease, the results have practical significance.

A natural mineral supplement provides relief from knee osteoarthritis symptoms: a randomized controlled pilot trial.

BACKGROUND: This small, pilot study evaluated the impact of treatment with a natural multi-mineral supplement from seaweed (Aquamin) on walking distance, pain and joint mobility in subjects with moderate to severe osteoarthritis of the knee. METHODS: Subjects (n = 70) with moderate to severe osteoarthritis of the knee were randomized to four double-blinded treatments for 12 weeks: (a) Glucosamine sulfate (1500 mg/d); (b) Aquamin (2400 mg/d); (c) Combined treatment composed of Glucosamine sulfate (1500 mg/d) plus Aquamin (2400 mg/d) and (d) Placebo. Primary outcome measures were WOMAC scores and 6 Minute Walking Distances (6 MWD). Laboratory based blood tests were used as safety measures. RESULTS: Fifty subjects completed the study and analysis of the data showed significant differences between the groups for changes in WOMAC pain scores over time (p = 0.009 ANCOVA); however, these data must be reviewed with caution since significant differences were found between the groups at baseline for WOMAC pain and stiffness scores (p = 0.0039 and p = 0.013, respectively, ANOVA). Only the Aquamin and Glucosamine groups demonstrated significant improvements in symptoms over the course of the study. The combination group (like the placebo group) did not show any significant improvements in OA symptoms in this trial. Within group analysis demonstrated significant improvements over time on treatment for the WOMAC pain, activity, composite and stiffness (Aquamin only) scores as well as the 6 minute walking distances for subjects in the Aquamin and Glucosamine treatment groups. The Aquamin and Glucosamine groups walked 101 feet (+7%) and 56 feet (+3.5%) extra respectively. All treatments were well tolerated and the adverse events profiles were not significantly different between the groups. CONCLUSION: This small preliminary study suggested that a multi mineral supplement (Aquamin) may reduce the pain and stiffness of osteoarthritis of the knee over 12 weeks of treatment and warrants further study. TRIAL REGISTRATION: ClinicalTrials.gov number: NCT00452101.

HUM5007, a novel combination of thermogenic compounds, and 3-acetyl-7-oxo-dehydroepiandrosterone: each increases the resting metabolic rate of overweight adults.

This study tested the hypothesis that 3-acetyl-7-oxo-dehydroepiandrosterone alone (7-Keto) and in combination with calcium citrate, green tea extract, ascorbic acid, chromium nicotinate and cholecalciferol (HUM5007) will increase the resting metabolic rate (RMR) of overweight subjects maintained on a calorie-restricted diet. In this randomized, double-blind, placebo-controlled, crossover trial, overweight adults on a calorie-restricted diet were randomized to three 7-day treatment periods with 7-Keto, HUM5007 or placebo. Resting metabolic rate was measured by indirect calorimetry at the beginning and end of each treatment period with a 7-day washout between testing periods. Of 45 subjects enrolled, 40 completed the study (30 women, 10 men; mean age, 38.5 years; mean mass index, 32.0 kg/m(2)). During the placebo treatment, RMR decreased by 3.9% (75+/-111 kcal/day; mean+/-S.D.); however, RMR increased significantly by 1.4% (21+/-115 kcal/day) and 3.4% (59+/-118 kcal/day) during the 7-Keto and HUM5007 treatment periods, respectively (each compared to placebo, P=.001). No significant differences were found between the treatment periods with respect to compliance or adverse events. In this study, the administration of HUM5007 or 7-Keto reversed the decrease in RMR normally associated with dieting. HUM5007 and 7-Keto increased RMR above basal levels and may benefit obese individuals with impaired energy expenditure. HUM5007 and 7-Keto were generally well tolerated and no serious adverse events were reported.