As overweight and obesity are becoming more prevalent in developed countries, devising effective approaches to losing weight is an important task. The simplified approach to weight loss focuses on managing energy intake and energy expenditure. In this study, Valentin S. Panayotov sought to examine how the placebo effect may complicate the purely mathematical model of weight loss. Although the study relied on a small sample, the finding contributes to understanding of the psychological aspects of the weight loss process. All subjects provided informed consent in the form of a written consent form.
The study was approved by Western Institutional Review Board. The study consisted of 8 visits over approximately 13 weeks.
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Subjects were randomized in a fashion to receive either the Release supplement or matching placebo and instructed to take one capsule three times a day with meals. Subjects and study staff were blinded to the treatment allocation, and Release supplement and matching placebo capsules were supplied in blinded containers.
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Placebo capsule contained maltodextrin. At each in-office visit, unused Release supplement tablets and placebo were collected, compliance was calculated by pill counting, and open labeled count Release supplement bottles were dispensed as needed. Laboratory and body measurements were obtained as outlined below. Visit 2 consisted of a telephone call to subjects to assess tolerability of the program. At approximately 2-week intervals, subjects returned for an office visit for compliance and tolerability assessment and body measurements.
The final visit 8 occurred at approximately week 13 and included body measurements, laboratory analysis and compliance and tolerability assessment. Body measurements were completed at in-office visits 1, 3 and 4 and included fasting weight, height, waist and hip circumference, and resting blood pressure and pulse. Laboratory evaluations were completed at Visit 1 and Visit 8 which included hemoglobin A1C, fasting insulin, fasting blood glucose and lipid panel total cholesterol, LDL, HDL, triglycerides.
A metabolic panel was also completed at Visit 1 and Visit 8 that included sodium, potassium, chloride, BUN, creatinine, calcium, total protein, albumin, alkaline phosphate, AST, ALT and carbon dioxide.
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Secondary endpoints included differences in body measurements and body composition analysis, vital signs, A1C, fasting blood glucose, fasting insulin levels and HOMA-IR at the end of 13 weeks of treatment between the two treatment groups. Additional secondary endpoints included changes in lipid panel and metabolic panel results at the end of the study between the groups. Additional safety evaluations included the tracking of adverse events throughout the study period. Differences between the treatment and control groups were analyzed using two-tailed t-tests assuming unequal variances at a significance level of 0.
These tests were used to compare the change of each group over the week trial and to assess randomization of the subjects. At visit 1 subjects were educated on the GWMP diet and exercise plan and were given the same supplemental information given to GOLO commercial customers.
Subjects were instructed to select at least one serving from each of 4 food groups protein, vegetables, carbohydrates and fats at each of the three meals. Examples of possible serving choices were outlined in the GOLO literature. Basal metabolic rates were derived at enrollment through a predetermined conversion based on sex, age, waist size and activity level.
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Subjects were instructed to add additional calorie allowances based on additional exercise as outlined in the GOLO literature. Daily calorie goals represented an approximately calorie reduction from baseline maintenance levels. Exercise was tracked in minute increments in a subject diary.
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Sixty-eight subjects were consented and randomized into the study. Average baseline characteristics of the subjects are contained in table 1. The average baseline weight was Among the initial study population, average hemoglobin A1C 5. This reflected the mixed nature of the group which contained both diabetic subjects and non-diabetic subjects and the heterogeneity of pre-treatment with anti-diabetic, blood pressure and cholesterol medications. While the average fasting insulin level [ Table 2 describes the comparison of baseline characteristics between the placebo and treatment groups.
Generally, baseline differences were minor and not statistically significant. However, baseline diastolic blood pressure and pulse were higher in the treatment group at baseline than the placebo group, a difference that reached statistical significance. Table 2. Baseline comparison of placebo group to treatment group, as mean SD.
Of those subjects, 16 subjects randomized to placebo Group A and 18 subjects randomized to Release supplement Group B. Of that total, 5 subjects had been previously diagnosed with type 2 diabetes and were on oral anti-diabetic therapy. Of the 68 subjects screened, 20 subjects self-terminated early for personal reasons lack of time to participate, travel, personal emergencies , 11 subjects were removed early for poor compliance with diet or pill counts and 3 subjects withdrew for adverse events 2 loose stool, 1 nausea.
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Changes from baseline week 1 to week 13 in weight, BMI, body analysis and body measurements for each group are listed in table 3. In terms of the primary endpoint, subjects randomized to the Release supplement lost statistically significant more weight than those assigned to placebo [placebo In addition, reductions in waist circumference [placebo In terms of vital signs, subjects randomized to the Release supplement showed statistically significant greater reductions in diastolic BP [placebo 1. Changes from baseline week 1 to week 13 in markers of glycemic control and insulin sensitivity are listed in table 4.
Levels of fasting blood glucose [placebo 0. However, markers of insulin resistance improved significantly in the Release-treated group, with insulin levels decreasing more in the treatment group than in the placebo group [placebo 1. Table 4. As humans we are designed to avoid pain and achieve pleasure. Totally ignoring the fact that medium and longer term it will actually bring massive pain — quite literally if they end up having a heart attack. Doctors have known about the power of the placebo effect for decades; up until the late s it was part of routine care and doctors in the US could legally prescribe placebos, and even specify what colour the sugar pill should be.
The most important fact is that the placebo effect is based on having a belief that is so unquestioning and powerful, it can change our neurology as well as our cell biology. Editor's note: Learn more and find out how to harness the placebo effect for weight-loss in Janet Thomsons' book The Placebo Diet:. Skip to main content. Janet Thomson More by this author. Feb 26, at AM.