A Double Blind, Placebo Controlled Study of the Effects of
Pectate® on Weight and Body Mass Index (BMI).
Prof. HH Vorster D.SC, Prof. CS Venter
D.Sc; RD, Prof. JC Jelring Ph.D, Dr. HS Kruger M.Pharm; Ph.D - RD, Dr. TA Nell
Ph.D, Dr. A Kruger Ph.D; RN, Sr. MC Lessing RN, Ms. HH Vorster M.Sc; RD, Ms. G
Hanekom M.Sc; RD, Ms. L Matshego B.Honns
From the Nutrition Research Group, Potchefstroom University,
South Africa
Background
Obesity is now regarded as a disease and an increasing public
health problem worldwide. Both prevention
on a population level and treatment on an individual level have proven to be
unsuccessful. There seems to be a need
for an effective and safe drug to assist in the treatment of obesity.
Researchers of the Nutrition Laboratory at Potchefstroom University have
reported that a substance tested for effects on fibrin network characteristics,
had weight reducing effects in a group of hyperlipidaemic patients, suggesting
that it may be a suitable agent to use for weight loss.
The substance has been patented by the University and incorporated as an
active ingredient of a dietary supplement prescribed for weight loss.
In the rest of this report, the substance will be referred to as PECTATEâ
Objectives
The main objective of this study was to examine the effect of
PECTATEâ
in conjunction with an energy-restricted diet for 12 weeks on weight loss in
obese subjects. In addition, the
independent effect of a metabolic herbal blend was also examined. Reported side effects and compliance to the supplement were
monitored as were effects on hemoglobin, haematocrit, plasma fibrinogen and
serum lipids.
Methods
A double-blind, placebo-controlled study design was used.
Of the 120 volunteers who responded to local advertisements, 80 subjects
(9 men/ 71 women) met the inclusion criteria during screening in the Metabolic
Unit of the University. These 80 were
randomly allocated to three groups, each receiving a supplement, plus a
prescribed diet. The participating
subjects as well as the researchers were blinded to the supplement, marked C, B
and O.
Group 1 (C) was the active ingredient group, taking 5mL
PECTATEâ
twice daily in a glass of water before meals.
Group 2 (B) took the same amount of placebo (lactose) and Group 3
(O), designated the metabolic group, took a metabolic herbal formula.
All subjects received individual dietary instructions and were weighed
weekly for the 12 weeks, during which compliance to the intervention was
discussed and monitored. Blood samples were taken at baseline and after 12 weeks for
biochemical analysis. The SPSS program
was used to determine statistical significant changes within and between groups.
Results
Of the 80 subjects, 5 (all women) dropped out of the study.
The 75 subjects who completed the study were divided into compliers and
non-compliers, based on reported intake of the supplements.
The compliers in the PECTATEâ
group lost significantly more weight (20.3 lbs compared 12 lbs of the metabolic
group). They reduced their BMI
significantly more (3.3 compared to 1.9 kg/m2).
The weight loss was accompanied by the expected reduction in body
circumferences. It seems that the
energy- restricted diet caused a statistically but not clinically significant
reduction in mean blood hemoglobin. The
study confirmed previous observations that plasma fibrinogen may rise during
rapid weight loss, probably because of mobilization of free fatty acids.
It seems as if the active ingredient may have been a protective effect in
this regard. The reductions in
total and LDL- cholesterol were not significant.
Conclusions
It is concluded that when taken as prescribed, PECTATEâ
is a successful weight loss supplement. It
is also concluded that the metabolic herbal blend does not have the same
properties as PECTATEâ.