FitTea Clinical Study

 FitTea Clinical Study

Sponsor/ Study Title: Fit Products, Inc/ “Trial of the Effects of FitTea, a 28-Day Diatary Supplement, on Weight Loss, Appetite, Alertness and Energy- ( the “FitTea” Study) Protocol Number: FT002 Principal Investigator:Sandeep Gaonkar, M.D. (Study Doctor) Study Coordinators:Amith Simpeti Janet Giblin Telephone:Office Phone Number (630)983-2000

Method

Participants

50 participants were enrolled in the study, of which 41 were females and 9 were males between the ages of 18 and 60. All participants in the study were volunteers and were recruited through various marketing resources. Participants who qualified for the screening process had a wide range of BMI and met inclusion and exclusion criteria.

 Materials

Informed consent forms were used containing information about the purpose of the study, procedures, benefits and risks of participating, availability of medical services, voluntary participation, researcher contact information, ingredients of the FítTea and its potential side effects as well as modalities used. A breakdown of each visit was also included in the informed consent. Additional materials such as questionnaires were also used to track the progress of each participant. The questionnaire included subset of questions that asked about the participants’ appetite, energy, concentration and adverse events. The participants were asked to select a number along the scale of 1-10 that most closely described their subjective feeling regarding the above-mentioned parameters. 

 Design and Procedure

The design of this study was non-experimental and it studied the efficacy of FitTea 28 day detox in aiding weight loss as a primary objective while increasing energy levels, concentration levels and decreasing appetite as a secondary objective. As participants arrived for their screening visit, denoted as visit 1, they were asked general demographical questions after which they were briefly explained the outline of the study. The informed consent was discussed in detail and was signed by the participants and the study coordinator. If requested by the participant, a copy of the informed consent was given to them on that same day. The research coordinator then made sure that the participants met the inclusion and exclusion criteria for the study. After obtaining the above, relevant questions regarding past medical history, surgical history and if they were on any current medications were noted. The principal investigator of the study then conducted a thorough physical exam and the participant was taken into our research facility lab where vitals, height, weight and fasting blood draw were performed. Blood was drawn to analyze for TSH levels, complete blood count, comprehensive metabolic panel and lipid levels. Finally, the height and weight measured in the lab was subsequently inputted into the DEXA scan which gave the participants bone density T-Score and Z-Score and more importantly the body fat percentage. Blood work was sent out to the HealthLab for further analysis. This concluded the screening visit. 

 

The subsequent visits had a standardized questionnaire consisting of four domains assessing appetite, energy/fatigue/tiredness, concentration/alertness and adverse symptoms. Each domain had a subset of questions; a graduated scale of 10 points for appetite and concentration and a four-point severity scale for energy. Furthermore, the adverse events were categorized into nine common symptoms. 

 

Visit 2 was scheduled after lab values were reviewed by the principal investigator to ensure that the participant did not demand immediate attention. While the participant was given the FitTea 28 day detox bag the potential side effects and the proper directions in how to take the investigational product were given to the participant in verbal and written form. Also, a baseline for the above mentioned parameters for each participant was established during this visit using the standardized questionnaire. 

 

Visit 3 was conducted over the phone seven days after visit 2. The questionnaire mentioned in the material section was used to assess appetite, energy and concentration changes over the course of the seven days. Any adverse effects were also noted. In addition, participants were asked if they lost any weight. Participants were instructed to continue drinking the tea in the morning for the next seven days and at that time their visit 4 was scheduled.

 

For the 4th visit, the participant was asked to come into the research facility seven days after visit 3. The same questionnaire was answered by the participant. During this time, the participant’s weight was measured and recorded and their next visit was scheduled. 

 

Visit 5 was conducted in the same manner as visit 3 seven days after visit 4. Participants were asked the same questions from the above-mentioned questionnaire. 

 

Visit 6 was the final visit and was done approximately 28 days after the initiation of the tea. Participants were scheduled to come into the research facility to measure vital signs, weight and for a fasting blood draw. The blood was sent to the lab to measure the same parameters that were measured during the first visit. In addition, a final DEXA scan was conducted to determine any change in body fat percentage. Finally, the questionnaire was used to assess and record any final changes in appetite, energy and concentration levels.

 

Results 

These data are comprised of 50 individuals with a starting baseline weight, a weight after 14 days and a weight after 28 days. Of the 50 individuals 25 or 50% had lost weight within the first 14 days and 33 or 66% had lost weight within the 28-day period. Of the 33 participants who lost weight; 24 participants or 72.7% lost 3 or more pounds and 14 or 42.4% of those lost 5 or more pounds by the end of the study. The average baseline weight was 224.28 with an average weight after 28 days was 221.67. The percent of average weight loss for the first 14 days was 0.64%. This increased from the 0.64% in 14 days to 1.26% after 28 days. The average number of pounds lost within the first 14 days was 0.5 and increase to an average of 2 pounds after 28 days. 

 

 

14 days

28 days

Average pounds lost

0.5

2

Average % of weight lost

0.64%

1.26%

 

 

Table 1.1Percentage of 33 participants who lost three pounds or more at day 14 and day 28.

 

# of Participants who lost 3 or more pounds

% of Participants who lost 3 or more pounds

14 Days

13

39.3%

28 Days

24

72.7%

 

 

Table 1.2 Percentage of 33 participants who lost five pounds or more at day 14 and day 28.

 

# of Participants who lost 5 or more pounds

% of Participants who lost 5 or more pounds

14 Days

3

9%

28 Days

14

42.4%

 

As for the results of the secondary objective, 43 of the 50 participants stated that they had increased energy levels, 42 of the 50 participants noticed an increase in concentration and finally 47 of the 50 participants indicated a decrease in appetite. 

 

Table 1.3 Percentage of 50 participants with changes in energy, concentration and appetite.

 

Energy levels

Concentration levels

Appetite

Number of Participants

43/50

42/50

47/50

Percentage of Participants

86%

84%

94%

 

 

Finally, of the 50 participants 12 complained of side effects which were transient self-resolving. 

 

 

Table 1.4 Number of participants with side effects.

Adverse symptoms

Bloating

Irritability

Anxiety

Insomnia

Skin Rash

Nausea

Vomiting

Diarrhea

Headache

Other

Number of Participants affected

2

 

1

1

2

0

2

2

3

3

2

 

 

Distribution of data

Below in graph 1 shows the distribution of data results for weight loss after 14 days and then after 28 days. This is showing the percentage of individuals within pounds. For example, the first histogram shows about 50% of the population had no weight loss in the first 14 days. Then in the next histogram for 28 days that 50% decrease and you start to see a shift in the percentage of individuals loosing 5 to 10 pounds lost increase. The normal and kernel is indicating a normal distribution where the kernel indicates the distribution of the data. What we like to see is the distribution to be normal. The first histogram shows a distribution slightly skewed right. The second histogram representing the 28 days is starting to show a more normal distribution. Below the histograms are box plots that is another way of displaying the distribution of data. The box portion is showing the mid-range or inner quartile range of the data with the mean and median. Whereas the lines are indicating the upper and lower quartiles. 

 

 

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Fig:1

 

P-Value

The p-value is the probability of finding the observed or more extreme results of a null hypothesis (equation.pdf) is true. In the tea study case, null hypothesis is that there is no difference in weight when drinking the tea. The alternative hypothesis (equation_1.pdf is the opposite of the null hypothesis and for the tea study is the one that is investigated. 

 

equation_2.pdf – there is no change in weight after 28 days

equation_3.pdf – there is a significance in weight after 28 days

 

Statistically significant p value should be less than 0.05. The result of this study is showing that the p-value =0.0244. Therefore, there is enough evidence to suggest that there is a significant change in weight after 28 days of drinking the FÍTtea. 

 

The new FitTea FatBurner contains ingredients that are clinically researched* to help burn calories.  

The FitTea FatBurner contains Green Tea, to read clinical research on the benefits of Green Tea click here.

The FitTea FatBurner contains 550mg of EGCG, to read clinical research on the weight loss benefits of EGCG click here.

Studies Used:
http://www.tandfonline.com/doi/abs/10...
http://www.nature.com/ijo/journal/v24...
http://www.ncbi.nlm.nih.gov/pubmed/18...
http://www.ncbi.nlm.nih.gov/pubmed/17...
http://www.ncbi.nlm.nih.gov/pubmed/18...
http://www.ncbi.nlm.nih.gov/pubmed/16...
http://jn.nutrition.org/content/139/2...
http://onlinelibrary.wiley.com/doi/10...
http://www.ncbi.nlm.nih.gov/pubmed/19... 

 

*These statements have not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure or prevent any disease.