Tag Archive for: HOMA-IR

Researching GOLO’s Claims

Before I get into the rest of the research on the claims made by GOLO, I want to be clear that I have nothing against any products or programs in the market. I’m not assessing the entire program for any company. But having worked for a couple of decades with companies that follow the FDA and FTC Guidelines for dietary supplements very closely, it’s more than frustrating when companies play loose with the research. If they make a structure-function claim, they should be able to substantiate those claims according to the guidelines.

Published Studies

The GOLO website refers to two studies that were published in journals. In the first study, a researcher assessed the effectiveness of the GOLO program on measures of weight and glycemic control. The study lasted 13 weeks; 16 out of 26 subjects completed the trial. There were significant reductions in body weight and insulin levels.

In a second study, the same researcher compared the subjects who used the GOLO weight loss program. The control group was given a placebo and the experimental group was given the program’s dietary supplement. The treatment group lost more body weight than the controls; there were also positive changes in serum insulin and a score of insulin resistance.

The implication is that in all studies, published or not, the dietary supplement made the difference in the results. There’s no way to tell. While every study talked about caloric intake, they did not report comparative data, either within subjects when there was no control group, or between groups when there was. This is simply poor research methodology and statistical analysis.

Does the Research Prove the Claim?

As I said on Thursday, while the company makes many claims on the website, I stuck to the one that said the product was “clinically proven to reduce insulin resistance.” They did not prove that the dietary supplement helped reduce insulin levels, blood glucose levels, or HOMA-IR, a measure of insulin resistance. There were just too many confounding variables they did not examine. I already made mention of the caloric intake. The program evolved over time from one where they planned a 500-calorie deficient diet for the subjects to one where they were advised on how to construct a diet from certain food selections. That’s why caloric intake is so important; we need to know that to find out how well the subjects met the dietary guidelines. The best they could claim is that the supplement may have assisted some subjects to lose weight.

In each study, the changes in HbA1c were relatively meaningless in the real world; reducing HbA1c by 0.18% and 0.61% is within the error of the method. As for the use of HOMA-IR, the researcher who developed the algorithm has said that it was not suitable for these types of clinical trials, just for large epidemiologic studies. Finally, the reduction in blood sugar in every trial where it was measured could be explained by exercise, which they also did not account for in the analysis; many people don’t realize exercise can modify insulin resistance by the third workout.

The Bottom Line

There were many more issues with the selection of data used in the multiple analyses and in the choice of statistics themselves. Most importantly, the significant loss of subjects—all four lost up to 40% of all subjects—was acknowledged by the authors, but they didn’t explain its impact. I could go on with errors, but it’s unnecessary. For the claims made, the level of substantiation is simply not sufficient to exhibit the dietary supplement’s benefit for insulin resistance. The weight loss program may be beneficial, but it can’t be verified by any of the studies they completed or by the materials provided on their website.

Eat less. Eat better. Move more. Do those long enough and you will be able to lose weight, get fit, and improve your metabolism as well.

What are you prepared to do today?

        Dr. Chet

References:
1. Diabetes Updates, 2019 doi: 10.15761/DU.1000125.
2. Trends Diabetes Metab, 2019 doi: 10.15761/TDM.1000109.