Why are you using something not FDA approved for weight loss?

First, because it works.  Many other frequently prescribed medications began their most common uses as an “off label use” i.e.  Bupropion/Wellbutrin for smoking cessation (Zyban).   Physicians are still allowed to prescribe medicines based on clinical evidence.  We do have some patients who cannot afford to stay in the hCG but want to continue the diet.  The majority are not able to continue for very long due to excessive hunger.  Second, we lack the current research to seek FDA approval.  All the studies I have seen (not including review articles – summaries of previous studies) to place in the mid 70s …35 years is not exactly current research.  Unfortunately, as such a small company, we lack the funding to sponsor a full blown clinical trial.  Reference article on the abundance of off- label prescriptions being used.


 Why are you using something that is produced by some types of cancer cells?

hCG is secreted by some cancer types (some testicular and ovarian germ cell cancers)  The physiological effect of that hCG is unlikely to be harmful but rather a clever way for the tumor to avoid the immune system by masking itself as a fetus and/or for promoting vessel formation (angiogenesis), which is a known effect of tumor secreted hCG.  We do not accept any patients who have active cancers and/or are undergoing current cancer treatment into the program.  Actually, hCG is also being studied for the potential use in the prevention of breast cancer. (Janssens et al.  HCG and the prevention of breast cancer.  Mol Cell Endocrinol. 2007 Apr 15;269(1-2):93-8. Epub 2007 Feb 11.)  BTW, also an off-label use.  hCG at such a low dose does not cause cancer.

 It sounds like you would lose weight on just the diet, is there any proof that hCG helps you lose weight?

The proof is in the weight lost by the thousands of patients who have successfully completed the program.  Again, research on the subject is outdated, having happened in the 70s and early 80s.  We are currently working on compiling data from our patient population to show a statistically significant positive result when using hCG to help weight loss.

 How does hCG work?

The ketogenic diet is the key for the weight loss.  hCG may increase adiponectin, leptin, and insulin sensitivities in the hypothalamus thus helping with appetite, satiety, and mood.  It may also have similar actions to LH, increasing testosterone levels in males and progesterone in females.  It may mimic the effects of hypothalamic hormones.

hCG is also an anti-insulin hormone which can create a diabetic state for the mother (gestational diabetes), consequently supplying more glucose for the fetus.

hCG is known to regulate epidermal growth factors which play roles with collagen and elastin fibers.  hCG administration may decrease activity of alpha-glycerophospahte dehydrogenase and glucose-6-phosphate dehydrogenase in hepatic and adipose tissues, suggesting decreased lipogenic activity i.e less fat production.

hCG increases beta-endorphine and modulates opioid activity in the hypothalamus.

hCG is known to accumulate in the hypothalamus and the hippocampus (important for memory, emotions, and spacial recognition) which contains the highest number of hCG receptors.

hCG profoundly influences NK cells and T cells to assure immunological tolerance and angiogenesis.

 How does Ketosis work?

The ketogenic diet is the key for the weight loss.  Triglycerides (triacylglycerol) are broken down into fatty acids that can be utilized for energy through the krebs cycle and 1 glycerol that can be converted into glucose.  Since fatty acids cannot cross the blood brain barriers, glucose is still essential for brain function.  Muscle is broken down in times of glucose deficiency.  One way our program differs from the Simeons 500 calorie program is the presence of some carbohydrate in the 4X/day protein shakes, which prevents muscle wasting.  When muscle wasting occurs on the program (we test at 2 weeks and 4 weeks) people tend to gain back weight quickly.

 Will it cause females to become pregnant?

Unprotected sex will make a female become pregnant.  hCG is used for fertility to help make the uterine wall more receptive to implantation during in vitro fertilization.   It is structurally similar to LH (luteinizing hormone) so it can induce ovulation and testosterone release.

Yes, these effects are used to help infertile women get pregnant.   We advise women of child bearing age of this aspect of hCG usage and immediately discontinue the program if the is any chance that they have become pregnant.

 There are internet reports of hCG causing MS and autoimmune disease…what are the long term risk factors of taking hCG?

This program is a short term, low dose usage of hCG posing no long term risk factors.  Pregnant women have levels 100 times greater than the concentration used on our program for 9 months.  I do not believe pregnancy, or multiple pregnancies are a risk factor for MS and/ or autoimmune disease.  The link that has been established between hCG and autoimmune disease is fragile and anecdotal at best.   In some animal studies hCG has actually been shown to be an immune modulator.

 Do you require any laboratory testing?

We do not require laboratory testing to begin the weight loss program.  When necessary we will order labs or request current blood work from your primary care physician.  For the cash-based patient extensive laboratory work can be cost prohibitive, but because we are a Family Practice clinic, we can deal with all your health concerns including ordering imaging or blood work.  We include 2 and 4 week follow ups during which we repeat your BIA analysis to insure you are losing mostly fat and not muscle mass.

  What happens when those with an eating disorder attempt to begin the program?

There are certainly some that try to abuse the system but our company policy states that those under a BMI (body mass index) of 20 will not be eligible for the hCG program.  By the BMI scale, under weight is technically 18.5 but our goal is to help people achieve and maintain a healthy weight, which is why we make the cutoff at 20 BMI.

Any contraindications to the program?

  1. Diabetes Type 1 – risk of diabetic ketoacidosis, an emergent condition which can lead to coma and death if not treated immediately and aggressively.
  2. Advanced Kidney Disease – high protein diet is not compatible with severe, progressive kidney diseases causing proteinuria i.e. glomerulonephritis, diabetic nephropathy, etc.  In fact, protein restriction has been shown to slow the rate of kidney deterioration in those with diabetic nephropathy .[1]
  3. Severe arrhythmia or heart block – Not necessarily a contraindication, but the metabolic acidosis caused by the ketogenic diet can irritate cardiac muscle and increase frequency of arrhythmia.
  4. Recent or planned surgery – Any muscle that is broken down while in a ketotic state will readily be converted to usable sugars preferentially over stored body fat.  Healing times will be increased, would healing is poor and the body’s ability to respond to additional stressors is diminished.
  5. Cancer – Those in cancer therapy regimens are not accepted into the hCG weight loss program.  Potential interactions with cancer therapeutics, hCG and a ketogenic diet are poorly understood and potentially dangerous.  Other naturopathic therapies will benefit these patients immensely.
  6. Women who are pregnant or trying to get pregnant – Pregnant women already produce adequate amounts of hCG and weight loss is not recommended.  In fact, the hCG used in the program is isolated from the urine of pregnant women.  Since it is the hormone that turns a pregnancy test positive, women who are attempting pregnancy or having unprotected sex would not be able to accurately test themselves.   A ketogenic diet is strictly prohibited in a pregnant woman because fetal development may be adversely affected.  When there is a chance of pregnancy a woman must discontinue the program for at least 2 weeks and then take a pregnancy test.  As long as the test is negative, they may resume the program without any loading phase.
  7. Breast feeding – HCGs presence in breast milk has not been established; however, the breakdown of fat cells results in the release of fat soluable toxins such as heavy metals and pesticide residues that may end up in the breast milk.  The increased caloric demands of breast feeding would make participation in a ketogenic diet program very difficult and is not recommended.