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CONTENTS
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Materials and methods
The study design was of the double-blind type: neither treating physician nor patient knowing who was receiving hCG, or an inert substance (placebo). Female patients for the study were selected, since the clinic where the study was performed specializes in the diagnosis and treatment of gynecologic disorders. Details of the protocol were explained to eighty-three volunteers, who were solicited through a written announcement. Before being entered into the study they signed an informed consent in front of a neutral witness.
Inclusion criteria:
We required selected volunteers to meet the following criteria: being at least 25 % BMI (Body Mass Index) overweight, and in general healthy condition. If taking medication for obesity, such as anorectics or amphetamines, they should discontinue the medication at least one month prior the initiation of the study. Drugs to control their clinical diseases (hypertension, hypothyroidism, etc.) were allowed. No patients under steroid, diuretics or hormones were entered in the study. In the course of the study, volunteers were also asked about starting the use of medical prescribed drugs or pharmaceutical preparations during the trial period.
Exclusion criteria:
No teenagers and patients over 75 y.o were admitted to the study. No patients with severe and/or uncontrolled clinical diseases (cancer, IDDM, heart attacks, infarcts sequelae) were accepted. After applying the inclusion/exclusion criteria, we counted upon seventy subjects to divide in treatment groups. These women were assigned to groups Placebo (P, N=26) or hCG (N=44) by a simple randomized sampling method. This latter group was in turn splitted in two subgroups: G1 (N=36) and G2 (N=8), according to the hCG dose administered (see below).
Procedures:
All patients were Caucasic, ages ranging from 23 to 73 y.o (group P: 41 ± 13; group G1: 42 ± 12; group G2: 41 ± 14), a range of heights of 1,62 cm. to 1,81 cm., and overweight ranging from 25 to 49,9 on BMI
Tables.
Since there were no published reports on the oral use of hCG, group G2 was administered twice the dose of G1, to assess if hCG concentration may affect obtained
results.
The pharmacist prepared two types of vials: one containing saline solution
(Na Cl 0,9% w/v), and the other containing a diluted and
buffered solution of standardized hCG .
Vials were randomly labeled, each number corresponding to a patient. The pharmacist kept the codes in a sealed
envelope. They were opened after completing the protocol.
To obtain a complete copy of the procedure please email your
request at method@hcgobesity.org
. You must be a Licensed Healthcare Professional to get a
copy.
Diet plan:
The same
Very-Low-Calorie-Diet (VLCD), specific and detailed, was prescribed to all
groups. Breakfast: tea or coffee in any quantity without sugar. Only one tablespoonful of milk allowed in 24 hr. Saccharin or other sweeteners could be
used. Lunch: 100 grms. of veal, beef, chicken breast, fresh white
fish, lobster, crab or shrimp. All visible fat was carefully removed before
cooking, and the meat weighed raw. Salmon, tuna fish, herring, dried or pickled fish was not
allowed. The chicken breast was removed raw from the bird. One type of vegetable could be only chosen from the
following: spinach, chard, chicory, beet-greens, green salad,
tomatoes, celery, fennel, onions, red radishes, cucumbers, asparagus, and
cabbage. One breadstick (grissini) or one Melba toast was allowed, and an apple or an orange, or a handful of strawberries or
one-half grapefruit.
For dinner: The same four choices as lunch.
The juice of only one lemon daily was allowed for all purposes. Salt, pepper, vinegar, mustard power, garlic, sweet basil, parsley, thyme, marjoram, etc., could be used for seasoning, but no oil, butter or dressing. Tea, coffee, plain water, mineral water were the only drinks allowed, but they could be taken in any quantity and at all times.
Clinicometric controls:
Volunteers assisted twice weekly at the clinic to be controlled and weighed. The following evaluations were completed once a week:
I. Height and Weight, performed on a medical scale. Volunteers were weighed using normal underwear
II. Body circumferences. Using a flexible, non elastic metric tape, the following anatomic areas were
assessed:
- Wrist (WRT), at the level of flexion fold (wrist-forearm);
- Breast (BRE), submammary fold;
- Waist (WAT): at the hypogastric region level;
- Abdominal (ABD), at the navel level;
- Hips (HIP): pubic line;
- Thighs (THI): 8 cm. below pubic line;
- Suprapatelar (ROT), at the patella upper border;
- Ankle (ANK), at the flexion fold (peroneal protuberance).
III. Skinfold thickness. Using a Lange Skinfold Caliper (Cambridge Scientific Industries, Cambridge, Maryland), the following folds were examined:
- Tricipital (TRI), arm midline, posterior region and tricipital muscle zone;
- Anterior Axilar line (AXA), at the fold created when pinching the skin region at the level of the pectoralis muscle extending to the arm;
- Subscapular (SCA (I)): inferior scapular spine;
- Thoracic (TOR): at the fold created when pinching the region located immediately below the ribs, at the level of an imaginary line extending from anterior axilar line;
- Suprailiac (ILI), at the fold created 4 cm above the anterior superior iliac spine;
- Supraumbilical (UMB(u)), 3 cm above navel;
- Infraumbilical (UMB(l)), 3 cm below navel;
- Thighs (THI), internal aspect of thighs, eight cm below the pubic area;
- Patellar area (ROT), at the fold created when pinching the region located 6 cm medial to the internal patellar border.
IV. Bioelectrical
impedance. Using Tetrapolar Bioelectrical Impedance (TBI) with a body fat analyzer Maltron, model BF-905 (Maltron International Ltd., Rayleigh,
Essex).
Volunteers were suggested to void, placed on supine position thereafter, and allowed to rest half an hour before determination. Self-adhering electrodes were placed on extremities. Every determination was performed with a separate set of electrodes that were discarded after single use.
The following TBI determinations were assessed:
1. Fat weight (FW),
2. Lean weight (LW),
3. Water weight (WW),
4. Calories (CAL).
V. b-hCG determinations: all subjects enrolled in the trial were studied for plasmatic b-hCG levels by an ELISA test
(64) on 0-15-30 study
days.
VI. Mood questionnaire: from the first study week on, patients were given weekly self-administered questionnaires to be completed at home. It consisted of twenty-four questions related to their mood changes in the course of the study, plus four questions related to adverse drug effects. They returned the data at the time of the subsequent visit to the
clinic.
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(Abstract,Introduction) |
(Data analysis,Results) |
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NOTICE:
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