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 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.

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.

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.

Effect of lean system 7 on metabolic rate and body composition.

OBJECTIVE: This study 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. METHODS: In this randomized, double-blind, placebo-controlled study, 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 8 wk. RMR, body weight, body mass index, waist and hip circumferences, and body composition by dual-energy x-ray absorptiometry were measured at baseline and week 8. An intention-to-treat analysis was performed. RESULTS: Of 47 adults enrolled, 35 completed the study. Subjects taking the commercial weight-loss product had a significant (P = 0.03) increase in RMR, 7.2% increase versus 0.7% decrease in the placebo group. Subjects taking the commercial weight-loss product also had a significant (P = 0.04) decrease in hip circumference, 3.78 cm versus 2.07 cm in the placebo group. There were no other statistically significant differences in any other outcome variable, diet composition, exercise compliance, or adverse events. CONCLUSION: The results of this study showed that administration of a commercial weight-loss product to overweight adults in conjunction with a calorie-restricted diet and moderate exercise program effectively reverses the decrease in RMR associated with calorie restriction within this study population. The commercial weight-loss product was well tolerated, and there were no serious adverse events over the 8 wk studied.

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.

New therapy for the prevention and prophylactic treatment of acute radiation syndrome.

The risk of military personnel, first responders and civilians being exposed to lethal doses of ionising radiation is greater now than it was during the Cold War. Due to the increasing likelihood of exposure to ionising radiation, the need for medical radiation countermeasures has been recognised as a high priority in the US. At present, no approved drugs are available for the prevention or treatment of acute radiation syndrome, even though this is a top national priority. One promising investigational drug candidate for the indication of radioprotection is BIO 300. This agent is a medical radiation countermeasure that is intended for use as a prophylactic treatment for acute radiation syndrome. Novel products (such as BIO 300) that provide prophylactic protection are designed to be shelf stable for several years, more rapidly distributed and easily administered orally with a minimum of medical supervision.