How do you wake up and achieve your full potential in the world we live in today?
Do you have trouble losing weight no matter how good you eat or how much you exercise?
Are you someone who has struggled with weight gain throughout your life? Maybe at some point you lost that weight and then somehow gained it back? Have you found yourself yo-yo dieting, or perhaps in the past you've tried the latest diet or fitness trends that your friends are on, yet you find they don't work for you because the weight keeps coming back?
Your inability to lose weight is not your fault...
Have you heard of LEPTIN RESISTANCE? Studies have found that leptin resistance, chronic inflammation, hypertension, myocardial disease, hormone shifts, weight gain, obesity and the inability to lose weight often go hand-in-hand.
LEPTIN RESISTANCE can also lead to health conditions such as:
Your "Satiety Hormone" may hold the key to achieving your weight loss goals.
Leptin Resistance, often referred to as the "satiety hormone," is an important master hormone your body releases from fat cells to help regulate your energy expenditure. Leptin also crosses the blood-brain barrier to communicate with the hypothalamus in the brain to signal when you are hungry or full.
If leptin is the master hormone that tells you when it is time to stop eating—and leptin is produced by fat cells—more fat cells should equal more leptin and hunger levels should shut down. Unfortunately, in people who are overweight, leptin resistances often develop.
When leptin resistances develop, leptin signaling is interrupted, so that no matter how much leptin is produced, the brain does not get the message. Instead of interpreting that extra leptin coming from all those extra fat cells as a signal to stop eating, the malfunctioning metabolic and endocrine systems read the flood of leptin as a starvation alert. The result is uncontrollable cravings for food high in fat and carbohydrates to increase fat stores. The master hormone designed to police weight levels becomes at best ineffective.
Correcting leptin resistance can restore hormonal balance and possibly help you to control your appetite and shed stubborn pounds.
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In an 8-week double blind placebo clinical study on Zenith participants showed the following results...
AWAKEND™ ZENITH™ Frequently Asked Questions
Q1. What is ZENITH™?
A1. ZENITH is an all natural, clinically effective, patented formula that accelerates fat loss by working through the body’s leptin system. This breakthrough product gently decreases leptin levels to restore accurate communication between fat cells and the brain, allowing your brain to hear the "stop eating and burn fat" messages.*
Q2. What are the ingredients in ZENITH™?
A2. ZENITH is made from a proprietary blend of specific, highly-viscous polysaccharides known as hydroxypropyl methylcellulose or HPMCs and a cetylated fatty acid complex (CeladrinⓇ). ZENITH uses the exact dose and formula that was used in the clinical study.
Q3. How do I take ZENITH?
A3. Take two capsules, twice daily before your two largest meals. Some have reported better results if they take ZENITH, not more than 30 minutes prior to their two largest meals on an empty stomach.
Q4. Can children take ZENITH?
A4. Though all natural, ZENITH was formulated for adult use. Please consult your pediatrician before use in children under the age of 18.
Q5. Does ZENITH contain any stimulants?
A5. No, ZENITHdoes not contain any stimulants.
Q6. What is the shelf life of ZENITH?
A6. ZENITH has a two-year shelf life.
Q7. What type of capsules does ZENITH use?
A7. ZENITH uses a vegetarian capsule.
Q8. I have a medical condition, can I take ZENITH?
A8. For anyone with a medical condition, please take the product with the label and fact sheet to your physician and consult your healthcare provider.
Q9. I am taking medication (any type), can I take ZENITH™?
A9. Please consult your physician or healthcare provider before taking ZENITH. ZENITH is a dietary supplement and does not replace any type of medication.
Q10. Are there any human clinical trials on ZENITH?
A10. Yes. in an eight-week randomized, double-blind, placebo-controlled women were put on a diet and exercise program. Half of the women took ZENITH and the other half took a placebo. The women taking ZENITH:
Q11. What is leptin?
A11. Leptin is a signaling hormone that helps regulate appetite by telling your brain to either “keep eating and store fat” (when leptin levels increase) or “stop eating and burn fat” (when leptin levels decline). Leptin is made in your body’s fat cells. Research has shown that leptin levels correlate with the amount of body fat - the more body fat you have, the higher your leptin levels are likely to be. Overtime, this can result in the brain not being able to receive the ‘stop eating’ signals from leptin. Lower levels of leptin enhance metabolism and reduce appetite.
Q12. What is adiponectin?
A12. Adiponectin is also produced in your body’s fat cells and few other tissues. Research has shown that adiponectin levels correlate with body fat, however, in the opposite way of leptin - the more body fat you have the lower your adiponectin levels are likely to be. Adiponectin is involved in a number of cellular and metabolic processes including working with leptin, insulin, and helping to maintain a healthy and balanced immune system.
Q13. Why does the clinical study say participants took three capsules, twice daily before their two largest meals but the directions for use on ZENITH says to only take two capsules?
A13. The total dose used in the clinical study was 1200 mg of the proprietary blend before each of their two biggest meals (2400 mg total per day). That was split into three capsules of 400 mg each. Awakend has been able to optimize the formula and get the full 1200 mg dose into just two capsules (600 mg of the proprietary blend per capsule).
Q14. What analytical testing does ZENITH go through?
A14. ZENITH is manufactured at a cGMP facility and is tested for microbes, heavy metals, and other contaminants following cGMP standards.
Q15.What is hydroxypropyl methylcellulose, HPMC, hypromellose, and viscous polysaccharides and what do they do?
A15. They are all names for the same compounds. They are unique, non-fermentable, dietary fiber derived from cellulose.
Hydroxypropyl methylcellulose (also known as HPMC or viscous polysaccharides) work in a number of ways to support healthy weight management. First, they gel and expand in the stomach. This helps begin the signals telling the brain you are full and you will likely eat less at your next meal. Second, this gelling and expanding activity also helps bind up food making it less immediately bioavailable and calories are absorbed more slowly, ultimately decreasing the energy efficiency of the diet.
In an eight-week, randomized, double-blind, placebo-controlled study, women taking a combination of hydroxypropyl methylcellulose and cetylated fatty acids taking ZENITH lost 119 percent more body weight, 97 percent more body fat, and 92 percent more off their waist than those participants taking the placebo. They also saw their leptin levels decrease and adiponectin levels increase - two hormones responsible for feeling full and metabolic control.
Q16. Can you speak to the strength of the ZENITH human clinical trial on ZENITH?
A16. There are many factors that go into determining the strength and validity of a scientific publication, especially as it relates to human clinical trials. Below are eight important points to consider.
1) Study design?
Study design starts with the “experimental question.” For this study, the experimental question was if ZENITH™, in the background of a diet and exercise modifications, could further support body composition changes and overall health better than the placebo group that only did diet and exercise alone.
Next are the participants chosen for the study. In this case, it was 22, healthy women, with stable weight, and a BMI of greater than 25. These 22 women were then matched for anthropometric and body composition measures into either the placebo group or the group taking ZENITH. This is an important step because it helps ensure that both groups are equal in the key experimental metrics being measured throughout the study. This ensures the study starts on an equal playing field.
For this study, study design, study size, and experimental procedures were precisely laid out to ultimately answer their experimental question.
2) Experimental procedures?
Experimental procedures and controls are essential for the success of a study. What are the variables being measured and how are they being measured? Are the endpoints being measured appropriate to answer the experimental question? Are standard and accepted scientific protocols and measures being utilized?
For this study, the two most important conditions were the diet they were consuming (before and during the study) and how the exercise was being performed to ensure consistency across all study participants.
Diet logs were carefully monitored by a Registered Dietician. Diet logs were used to determine the number of baseline calories the subjects were consuming and were also kept during the study to ensure they were in a minor calorie deficit (~500 calories). Dietetic counseling was also made available to study participants.
The exercise program was consistent for every participant (four-five times per week), within set exertion minimums and maximums (60-90 percent of maximal heart rate), and overseen by trainers who recorded the data for all exercise sessions.
To measure circulating levels of the hormones leptin, adiponectin, and insulin standard and accepted tests were used. To measure body composition, the gold-standard, most accurate, and best accepted measure of body composition, Dual-Energy X-ray Absorptiometry, or DEXA, was used.
For this study, the experimental procedures employed allowed the researches to adequately and confidently answer their experimental questions.
3) Number of participants in the trial?
The number of participants included in any clinical trial is always a balancing act of budget (clinical trials are incredibly expensive), availability of study participants (how many people can be enrolled that meet the inclusion criteria), complexity of experimental design (how many subjects can the researchers manage during the study), and expected results.
The irony of the expect results is that results that are expected to only have small differences need very large groups of individuals while experiments where large differences are expected can utilize a smaller number of participants. The number of subjects required for a clinical study is done mathematically by utilizing power calculations before the study even starts. The number of participants required for this study was determined beforehand and why 22 participants were chosen.
The reason the number of subjects in a clinical trial is important is because the final data will be analyzed by statistical methods. These statistics determine whether or not a result is ‘real’ or ‘random.’ This is expressed as ‘statistical significance.’ Statistical significance indicates that a result is real and there is a true difference between the experimental groups and that this difference is not random.
Some might consider this study to be a relatively small study with 22 total participants, 11 per study group. In studies with a small number of participants, it makes it much more difficult to achieve statistical significance because of how the statistical models work. The fact this study showed such huge differences both between the start and end of the study AND between the two study groups, speaks to the power of the intervention (ZENITH™).
4) Length of the study?
The length of a clinical trial is an important part of the experimental design. The trial needs to be long enough to see results but not too short where any statistically significant findings won’t be seen. This study’s duration was eight weeks (~ two months) and in fact, participants taking ZENITH lost significantly more weight and body fat in the second month than the first.
5) Is the study blinded?
It is important that scientific studies are blinded to removed a well-documented phenomenon of researcher bias (researchers generally want studies to be positive).
Blinding a study means that all the key players involved in a study do not know which participants are in which study group. This can include the researchers, support staff, participants, etc.
This study was double-blinded meaning that both the researchers and participants did not know what group each was in until the conclusion of the study. This is important to remove positive (or negative) bias out of a study.
6) Was there a placebo control group?
There is a well-documented phenomenon in research known as the “placebo effect.” A placebo is anything that seems to be real, but has no active ingredients. This can be in the form of a pill, a shot, or some other type of fake treatment.
The placebo effect is really the power of the mind. If individuals believe they are being given something they believe will help them, they generally feel that their condition has improved.
This placebo effect has to be taken into account when doing a human clinical study to help normalize the data and account for this well-known, and well-documented effect. Having a placebo in a human clinical study removes this positive bias and adjust the final data to take this phenomenon into account.
This study contained a placebo-controlled group.
7) Statistics used to analyze the data?
Because statistics are used to analyze the final data to determine if the effect/intervention of a study is real or not, it is important that the proper statistics are used.
In this study, traditional and accepted statistical analyses were used in this study based on the type of data being analyzed. This helps ensure the results are real and not a random effect of something else not accounted for in the study.
8) Was the study published and in a reputable, peer-reviewed scientific journal?
It is one thing to conduct a study. But to put it out in the public domain, it needs to be written up, submitted to, and ultimately published by a scientific journal. This is done through the ‘peer-reviewed process.’The peer-reviewed process is critical to the scientific process and integrity of scientific data that gets published.
Once a study has been written, the author decides what scientific journal they’d like to have it published in. They submit their manuscript to the journal’s editor. The editor then identifies experts in the field and sends the manuscript out to these experts to be reviewed. These reviewers assess the quality of a manuscript based an the criteria above and others. The reviewers can accept a manuscript, reject a manuscript, or recommend follow-up studies or analyses to be done to make it scientifically rigorous enough for publication and to be put out in the scientific community.
Once a manuscript has been accepted, it gets a publication date (online and/or paper format) and is available for public access. All reputable scientific research should be available on the United States National Institutes of Health, National Library of Medicine website at PubMed.gov.
This study specifically can be found there at: https://pubmed.ncbi.nlm.nih.gov/19048277