Replies to post #23188 on Rock Creek Pharmaceuticals Inc. (fka RCPIQ)

[haysaw]

Very interesting. Here is the 19 subject human study portion, including the exclusion and diet criteria (from your 2nd link):

EXPERIMENTAL PROCEDURES
Subjects
Experimental design and report were prepared following the CONSORT standards for randomized clinical trials where applicable. Available data from an ongoing pilot trial are presented. Subjects were recruited under protocols approved by the IRB (HS-12-00391) of the University of Southern California based on established inclusion (generally healthy adult volunteers, 18–70 years of age, BMI: 18.5 and up) and exclusion (any major medical condition and chronic diseases, mental illness, drug dependency, hormone replacement therapy [DHEA, estrogen, thyroid, testosterone], females who are pregnant or nursing, special dietary requirements or food allergies, alcohol dependency) criteria. All participants signed informed consent forms and were not offered financial compensation for participation. Subjects were allocated (based on stratified sampling for age and gender) into a control (n = 19) or experimental diet group (FMD, n = 19), followed by baseline examination. The control group continued normal food consumption and returned for a follow-up examination 3 months after enrollment. Subjects in the FMD cohort consumed the provided experimental diet consisting of 3 cycles of 5 continuous days of FMD followed by 25 days of normal food intake. During all three FMD cycles, study participants self-reported adverse effects following Common Terminology Criteria for Adverse Events. For the FMD group, follow-up examinations occurred before resuming normal food intake at the end of the first cycle (FMD) and also after 5–8 days of normal feeding following the end of the third diet cycle (FMD-RF). Pre-specified outcome measures include adherence to the dietary protocol and evaluation of physiological markers during and after completion of the study. Examinations included height, dressed weight, body composition (including whole-body fat, soft lean tissue, and bone mineral content) measured by dual-energy X-ray absorptiometry (DEXA), and blood draw through venipuncture. All data were collected at the USC Diabetes & Obesity Research Institute. Complete metabolic panels were assayed by the Clinical Laboratories at the Keck Medical Center of USC immediately following blood draw. Data analysis was performed independent of study design. Complete data will be made available elsewhere upon completion of the study.

Human Diet
The human fasting mimicking diet (FMD) program is a plant-based diet program designed to attain fasting-like effects while providing micronutrient nourishment (vitamins, minerals, etc.) and minimize the burden of fasting. It comprises proprietary vegetable-based soups, energy bars, energy drinks, chip snacks, chamomile flower tea, and a vegetable supplement formula tablet (Table S4). The human FMD diet consists of a 5 day regimen: day 1 of the diet supplies
1,090 kcal (10% protein, 56% fat, 34% carbohydrate), days 2–5 are identical in formulation and provide 725 kcal (9% protein, 44% fat, 47% carbohydrate)