Effects of a pre-workout supplement on lean mass, muscular performance, subjective workout experience and biomarkers of safety.

In this prospective, randomized, double-blind, trial conducted in two parts, we examined the effects of a multi-ingredient pre-exercise workout supplement blend of creatine, betaine and a dendrobium extract (MMP) on safety, performance, and body composition in healthy men and women undergoing a supervised program of resistance exercise. Part 1 was an acute hemodynamic safety study wherein forty young, healthy men and women (26.2 ± 5.3 years, 70.4 ± 3.3 inches, 83.7 ± 14.9 kg, 26.0 ± 3.2 kg●m(-2)) ingest one dose of either the MMP or comparator in a randomized, double-blind, comparator controlled, crossover fashion before having their resting heart rate, blood, ECG and comprehensive blood chemistry and blood counts completed. Systolic (SBP) and diastolic (DBP) blood pressures were generally raised (3.0-5.4 mm Hg, p<0.01) following supplementation with MPP whereas in the comparator group SBP was marginally reduced by 0.3 to 1.2 mm Hg, p>0.05 at all time points) and DBP was increased (3.0 - 3.9 mm Hg, p<0.05 at all time points). No changes in EKG-corrected QT interval were observed, and no serious adverse events were reported. Part 2 was a six-week training study wherein forty-three young, healthy men and women (24.3 ± 2.9 years, 70.5 ± 3.1 inches, 83.8 ± 9.6 kg, 26.1 ± 2.7 kg●m(-2)) supplemented with daily pre-workout doses of either the MPP or a comparator in a randomized, double-blind, comparator-controlled fashion while following a standardized resistance training program for six weeks. MPP and the comparator were isocaloric and delivered the same amount of caffeine. Significant improvements in visual analog scale (VAS) scores for energy (p<0.024) and concentration (p<0.041) were found along with consistently higher levels of focus accompanied by less fatigue when MPP was consumed in comparison to comparator during upper body muscular strength-endurance tests at weeks 3 and 6. MPP supplementation for 6 weeks did not improve dual-energy x-ray absorptiometry (DEXA) measures of body composition or objective assessments of exercise performance. Overall, MPP use and administration was well tolerated. Self-reported scores for energy and concentration were significantly greater. Over a six-week training and supplementation period, MPP use was not associated with improvements in performance or body composition. Future studies should confirm these effects over a more prolonged training period.

Effects of Hemp Extract on Markers of Wellness, Stress Resilience, Recovery and Clinical Biomarkers of Safety in Overweight, But Otherwise Healthy Subjects.

We determined the effects of a commercially available, GRAS (Generally Recognized As Safe) by independent conclusion, CBD-containing hemp oil extract on stress resilience, perceived recovery, mood, affect, body composition, and clinical safety markers in healthy human subjects.Methods: Using a randomized, placebo-controlled, double-blind design, 65 overweight, but otherwise healthy men and women (35.2 ± 11.4 years, 28.5 ± 3.3 kg/m2) ingested either Hemp Oil Extract [Hemp, 60 mg/d PlusCBDTM Extra Strength Hemp Extract Oil (15 mg hemp-derived CBD)] or a placebo (PLA) every day for six weeks while continuing to follow their normal diet and physical activity patterns. Outcome variables included changes in stress resilience, a 14-item panel of various psychometric parameters, heart-rate variability, plasma chromogranin A, body composition, and general markers of health. Data were analyzed using mixed factorial ANOVA, t-tests with 95% confidence intervals, and effect sizes (ES).Results: HDL cholesterol significantly improved in the Hemp group (p = 0.004; ES = 0.75). No other statistically significant group x time interaction effects were observed. Statistical tendencies for between-group differences were found for 'I Get Pleasure From Life' (p = 0.06, ES = 0.48) and 'Ability to Cope with Stress' (p = 0.07, ES = 0.46). Sleep quality (Hemp, p = 0.005, ES = 0.54) and sleep quantity (Hemp, p = 0.01, ES = 0.58) exhibited significant within-group changes. All values for hepato-renal function, cardiovascular health, fasting blood lipids, and whole blood cell counts remained within normal clinical limits with no between-group differences over time being identified.Conclusions: Hemp supplementation improved HDL cholesterol, tended to support psychometric measures of perceived sleep, stress response, and perceived life pleasure and was well tolerated with no clinically relevant safety concerns. Registered at clinicaltrials.gov: NCT04294706.

Proprietary Milk Protein Concentrate Reduces Joint Discomfort While Improving Exercise Performance in Non-Osteoarthritic Individuals.

Milk and dairy products are known to contain various bioactives with potential anti-inflammatory and immune modulating effects. Previous research has indicated that milk produced from hyperimmunized cows provided meaningful health benefits to individuals suffering from varying degrees of osteoarthritis and rheumatoid arthritis. PURPOSE: To examine the impact of MicroLactin®, a proprietary milk protein concentrate, on joint discomfort and physical function, exercise performance, quality of life and various measures of affect. METHODS: Non-osteoarthritic men (42.5 ± 8.9 years, 176.7 ± 6.7 cm, 89.9 ± 11.5 kg, 28.8 ± 3.5 kg/m², n = 30) and women (46.4 ± 9.6 years, 163.1 ± 8.2 cm, 72.2 ± 13.1 kg, 27.2 ± 5.3 kg/m², n = 28) with mild to moderate knee pain during physical activity were randomized in a double-blind, placebo-controlled fashion to consume daily either a placebo (PLA) or MicroLactin® (ML) for a period of 8 weeks. Participants completed a functional capacity test pre and post-supplementation and completed visual analog scales (VAS), a 6-min walking test, WOMAC and profile of mood states (POMS) to assess changes in joint health, discomfort, physical function, exercise performance and affect. Mixed factorial ANOVA was used for all statistical analysis and significance was set a priori at p ≤ 0.05. RESULTS: Distance covered in the 6-min walking significantly improved 9% in ML versus 2% in PLA (mean difference: 110 ± 43 m, p = 0.012) in addition to 11 WOMAC components and 5 VAS reflective of ML improving joint health, discomfort and joint stability (all p < 0.05 vs. PLA). Additionally, ML also improved overall perceptions of neck and back health compared to PLA. Serum and whole blood indicators of clinical safety remained within normal ranges throughout the study. CONCLUSIONS: In comparison to placebo, daily doses of MicroLactin® yielded improvements in several components of the WOMAC, multiple visual analog scales indicative of joint health and stability, discomfort and pain, as well as significant improvements in distance covered during a 6-min walking test. Supplementation was well tolerated with no significant changes in whole-blood or serum markers of clinical safety.

Effect of a Multi-Nutrient Over-the-Counter Supplement on Changes in Metabolic Rate and Markers of Lipolysis.

Using a prospective, randomized, double-blind, crossover study design, fifteen healthy male (n = 8) and female (n = 7) participants (mean ± standard deviation (SD): 28.3 ± 6.1 yr, 176.3 ± 11.4 cm, 89.8 ± 21.7 kg, 28.5 ± 4.8 kg/m2) completed this study. Two testing sessions occurred after an overnight fast and refraining from physical exercise. Prior to and 60, 120, and 180 minutes after single dose ingestion of placebo (PLA) or a Thermogenic Supplement (TS), visual analog scales (VAS), resting metabolic rate (VO2), and venous blood were collected. Resting heart rate and blood pressures were collected before, and 30, 60, 90, 120, 150 and 180 minutes after PLA or TS ingestion. Significant group × time interactions were found for VO2 with TS experiencing significant (p < 0.05) increases 60 and 120 minutes after ingestion. Respiratory quotient values tended to be lower 180 minutes (p = 0.07) after TS ingestion. TS group reported increased energy 60 minutes (p < 0.05) after ingestion. No interactions were reported for resting heart rate or blood pressure. Significant within-group reductions in systolic blood pressure were noted for PLA, while resting heart rates were significantly lower in TS 30 and 60 minutes after ingestion. An interaction for epinephrine (p = 0.02) was found, while no changes were reported for norepinephrine and dopamine. Dependent t-tests using area under the curve calculations revealed higher AUC values for epinephrine in TS compared to PLA (p = 0.001). In conclusion, ingestion of a single dose of TS increased oxygen consumption, epinephrine and energy levels, while substrate oxidation tended to change in comparison to a placebo. No adverse responses were reported.

A Two-Part Approach to Examine the Effects of Theacrine (TeaCrine®) Supplementation on Oxygen Consumption, Hemodynamic Responses, and Subjective Measures of Cognitive and Psychometric Parameters.

Theacrine (1,3,7,9-tetramethyluric acid) is a naturally occurring purine alkaloid, present in Camellia assamica variety kucha tea. Using a two-part approach in humans, the impact of theacrine (TeaCrine®, TC) was used to examine subjective dose-response, daily changes in cognitive and psychometric parameters, and changes in gas exchange and vital signs. All indicators were chosen to better ascertain the previously reported animal and human outcomes involving theacrine administration. Part 1 was a randomized, open-label, dose-response investigation in nine healthy participants whereby three participants ingested 400 mg TC per day and six participants ingested 200 mg/day. Participants recorded subjective changes in cognitive, psychometric, and exercise attributes using 150-mm anchored visual analog scale (VAS) before, and 1, 4, and 6 hours after ingestion every day for 7 consecutive days. Part 2 was a randomized, double-blind, placebo-controlled, crossover investigation in 15 healthy subjects in which all participants ingested a single 200 mg dose of TC or Placebo (PLA). Anchored VAS questionnaires were used to detect subjective changes in various aspects of physical and mental energy along with changes in gas exchange and hemodynamic parameters before, and 1, 2, and 3 hours after acute ingestion. Energy, focus, and concentration increased from baseline values in both doses with no dose-response effect. VAS responses in the 200 mg for willingness to exercise, anxiety, motivation to train and libido increased across the measurement period while no such change was seen with the 400 mg dose. After consuming a single 200 mg dose, significant group × time interaction effects were seen for energy, fatigue, and concentration. No changes in resting heart rate, gas exchange, systemic hemodynamics or side effect profiles were noted.

Effects of a dietary supplement on golf drive distance and functional indices of golf performance.

BACKGROUND: Limited research exists examining the impact of nutrition on golfing performance. This study's purpose was to determine the impact of daily supplementation with an over-the-counter dietary supplement on golf performance. METHODS: Healthy men (30.3 ± 6.9 y, 183.1 ± 5.6 cm, 86.7 ± 11.9 kg), with a 5-15 handicap were assigned in a double-blind, placebo-controlled manner to ingest for 30 days either a placebo (PLA, n = 13) or a dietary supplement containing creatine monohydrate, coffea arabica fruit extract, calcium fructoborate and vitamin D (Strong Drive™, SD, n = 14). Subjects ingested two daily doses for the first two weeks and one daily dose for the remaining two weeks. Participants followed their normal dietary habits and did not change their physical activity patterns. Two identical testing sessions in a pre/post fashion were completed consisting of a fasting blood sample, anthropometric measurements, 1-RM bench press, upper body power and golf swing performance using their driver and 7-iron. Data were analyzed using two-way mixed factorial ANOVAs and ANCOVA when baseline differences were present. Statistical significance was established a priori at p ≤ 0.05. RESULTS: ANCOVA revealed significantly greater (post-test) best drive distance (p = 0.04) for SD (+5.0% [+13.6 yards], ES = 0.75) as well as a tendency (p = 0.07) for average drive distance to increase (+8.4% [+19.6 yards], ES = 0.65), while no such changes were found with PLA (-0.5% [-1.2 yards], ES = 0.04 and +1.3% [+2.8 yards], ES = 0.08, respectively). Both groups experienced significant increases in body mass and 1-RM bench press (p < 0.001). No other significant group × time interactions were found. For the SD group only, within-group analysis confirmed significant improvements in set 1 average (+8.9%, p = 0.001) and peak velocity (+6.8%, p < =0.01). No changes were noted for reported adverse events, pain inventories, quality of life or any measured blood parameter. CONCLUSIONS: SD supplementation for 30 days significantly improved best drive distance more than placebo. Supplementation was well tolerated and did not result in any clinically significant changes in markers of health or adverse events/side effect profiles.