Glubloc™ Reduces Postprandial Blood Glucose Surge in Healthy Individuals (A Placebo Controlled Pilot study).

doi:10.21203/rs.3.rs-3038659/v2

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Glubloc™ Reduces Postprandial Blood Glucose Surge in Healthy Individuals (A Placebo Controlled Pilot study).

https://doi.org/10.21203/rs.3.rs-3038659/v2

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Background

High glycaemic index (GI) foods can lead to negative health outcomes such as glucose spikes, insulin resistance, weight gain, and glucose crashes. Glubloc™ is a proprietary plant extract blend of Morus alba L and Malus domestica rind, enriched with polyphenolic flavonoids that inhibits enzymes responsible for carbohydrate digestion and glucose absorption and has shown potential in modulating blood sugar surge post-meal intake.

Objective

This study was aimed to investigate the impact of Glubloc™ on postprandial glucose response (PPGR) in healthy individuals after consuming a high GI meal (300g cooked rice) or a sucrose drink (70g table sugar dissolved in 400ml water).

Design:

Two studies were conducted using a placebo-controlled design. Subjects (n = 40 for rice meal study, n = 40 for sucrose drink study) received either placebo or Glubloc™ (500mg) before the meal/drink. Blood glucose levels were measured at various time points up to 180 minutes for the rice meal study and 120 minutes for the sucrose drink study.

Results

Glubloc™ supplementation significantly reduced PPGR in both the rice meal study and sucrose drink study. Compared to the placebo group, Glubloc™ resulted in significantly lower incremental area under the curve (iAUC) values for glucose levels (1063 mg/dL × min vs. 5090 mg/dL × min for rice meal; 859 mg/dL × min vs. 2266 mg/dL × min for sucrose drink). No adverse events were reported.

Conclusions

Glubloc™ supplementation effectively reduced postprandial glucose response in healthy individuals consuming high GI meals or sucrose drinks. It demonstrated potential as a safe and effective means to modulate blood glucose levels, thereby minimizing the negative effects of glucose and insulin spikes associated with high GI foods. Glubloc™ could be a valuable supplement for individuals seeking to manage their blood glucose levels after consuming carbohydrate-rich meals or sugary beverages. Further research is warranted to explore its broader applications in managing metabolic conditions.

Endocrinology & Metabolism

Post Prandial Blood Glucose

Glubloc™

Blood Sugar Surge

Rice Meal

Sucrose Drink

Plant Extract Blend

The glycaemic index (GI) is a measure of how quickly a food raises blood glucose levels. Foods with a high GI are absorbed and digested quickly, leading to a rapid increase in blood glucose. In contrast, foods with a low GI are absorbed and digested more slowly, leading to a slower and more gradual increase in blood glucose. Eating high GI foods can lead to a number of negative health outcomes, including glucose spikes, insulin resistance, weight gain, and glucose crashes¹. Glucose spikes occur when blood glucose levels rise rapidly after eating a high GI food. This can lead to an overproduction of insulin, which is a hormone that helps regulate blood glucose levels. Over time, constantly high insulin levels can lead to insulin resistance, a condition in which the body becomes less sensitive to insulin and is unable to effectively lower blood glucose levels. Insulin resistance is a major risk factor for the development of type 2 diabetes^2,3.

In addition to insulin resistance, high GI foods can also contribute to weight gain. When blood glucose levels rise quickly, the body releases insulin to lower them. Insulin promotes the storage of fat, and high insulin levels can lead to increased fat storage, especially in the abdominal region. This can increase the risk of obesity and related health problems such as heart disease and stroke. High GI foods can also lead to glucose crashes, which occur when blood glucose levels drop rapidly after a meal. This can lead to feelings of weakness, fatigue, and irritability. Glucose crashes can be particularly problematic for athletes, as they can impair sports performance. There is also evidence to suggest that high GI foods may have negative effects on fitness and sports performance. In one study, athletes who consumed a high GI diet had lower levels of glycogen, a form of stored carbohydrate that is important for energy during exercise, compared to those who consumed a low GI diet. In addition, high GI foods may impair endurance and reduce the ability to recover after exercise^3,4.

The apple-derived compound phlorizin (Malus domestica peel extracts) and imino sugars from Morus alba leaf extracts have gained attention for their potential in blood glucose management^5–11. Bioactive constituents in Morus alba leaves inhibit alpha-glucosidase and alpha-amylase, slowing carbohydrate digestion and subsequent glucose release^{7–9, 12–14}. Additionally, both phlorizin and Morus alba leaf extracts show promise in regulating the glucose transporter SGLT-2^5,6. By inhibiting SGLT-2, these botanical extracts enhance glucose excretion and potentially improve glycaemic control. This regulation of digestive enzymes and glucose transporters offers opportunities for managing postprandial blood sugar surges in individuals with diabetes and healthy individuals.

Glubloc™ is a proprietary plant extract blend of Morus alba leaf and Malus domestica rind extracts. In the current study, we studied the impact of pre-meal Glubloc™ tablet on post prandial blood glucose surge post high GI meal or a sugary drink intake (ie., carbohydrate rich rice meal (300 g) or a sucrose drink (70 g of table sugar dissolved in 400 ml water)) in healthy individuals.

All subjects gave their informed consent for inclusion before their participation in the study. The study was conducted in accordance with the Declaration of Helsinki.

Selection of subjects and treatment schedule:

Study 1: Community and corporate working healthy subjects (n=40) with no disease or medication history were recruited for the study. On Day 1, Following an overnight fast of at least 10 hours, baseline (0 min) reading of blood glucose levels were recorded using Accu-Chek® Active blood glucometer (F. Hoffmann-La Roche AG). They were asked to administer per oral placebo capsule (500 mg) with a glass full (240 ml) of water. They were asked to eat 300 g of carbohydrate rich rice meal and were asked to eat it within 15 minutes or less. Blood glucose levels were measured at15, 30, 45, 60, 90, 120, 150, and 180 minutes through a finger prick assessment with Accu-Chek® Active blood glucometer (F. Hoffmann-La Roche AG). On Day 2, Following an overnight fast of at least 10 hours, baseline (0 min) reading of blood glucose levels were recorded using Accu-Chek® Active blood glucometer (F. Hoffmann-La Roche AG). They were asked to administer per oral Glubloc™ (500 mg) capsule with a glass full (240 ml) of water. They were asked to eat 300 g of rice meal and were asked to eat the meal in 15 minutes or less. Blood glucose levels were measured at15, 30, 45, 60, 90, 120, 150, and 180 minutes through a finger prick assessment with Accu-Chek® Active blood glucometer (F. Hoffmann-La Roche AG).

Study 2: Community and corporate working healthy subjects (n=40) with no disease or medication history were recruited for the study. On Day 1, Following an overnight fast of at least 10 hours, baseline (0 min) reading of blood glucose levels were recorded using Accu-Chek® Active blood glucometer (F. Hoffmann-La Roche AG). They were asked to administer per oral placebo capsule (500 mg) with a glass full (240 ml) of water. They were asked to drink 70 grams of sucrose (table sugar) dissolved in 400 ml of drinking water. Blood glucose levels were measured at15, 30, 45, 60, 90 and 120 minutes through a finger prick assessment with Accu-Chek® Active blood glucometer (F. Hoffmann-La Roche AG). On Day 2, Following an overnight fast of at least 10 hours, baseline (0 min) reading of blood glucose levels were recorded using Accu-Chek® Active blood glucometer (F. Hoffmann-La Roche AG). They were asked to administer per oral Glubloc™ (500 mg) capsule with a glass full (240 ml) of water. They were asked to drink 70 grams of sucrose (table sugar) completely dissolved in 400 ml of drinking water. Blood glucose levels were measured at15, 30, 45, 60, 90 and 120 minutes through a finger prick assessment with Accu-Chek® Active blood glucometer (F. Hoffmann-La Roche AG).

Statistical analysis:

In this study, the primary endpoint was the incremental area under the curve (iAUC) of the Post Prandial Glucose Response (PPGR) after a high carbohydrate meal or a sucrose drink. This value was calculated using the trapezoid method for each individual. The secondary endpoints were the maximal incremental glucose value (iCmax) and the time to reach this value (Tmax). Mean and SEM values were calculated and plotted for each timepoint

Study Flowchart:

Rice meal study design:

Sucrose drink study design:

Glubloc™ treatment reduced post prandial glucose response (PPGR) in healthy subjects post carbohydrate rich meal intake:

Post meal plasma glucose levels considerably increased in placebo treated subjects (n=20) with iCmax 51.2±6.4 mg/dL and iAUC _{(0-180 min)} 5090 mg/dL × min at Tmax 45 min when compared to the baseline (T 0min). However, in Glubloc™ treated subjects (n=20), significantly low plasma glucose levels were observed with iCmax 13.8±4.2 mg/dL and iAUC _{(0-180 min)} 1063 mg/dL × min at Tmax 45 minutes when compared to the baseline (T 0min).

Table 1: Descriptive statistics for placebo and Glubloc™ post 300g cooked carbohydrate meal intake.

	iAUC _(0-180min)	iCMax	Tmax
	[mg/dL × min]	[mg/dL]	[min]
Placebo	5090	51.2±6.4	45
Glubloc™	1063	13.8±4.2	45

Glubloc™ treatment reduced post prandial glucose response (PPGR) in healthy subjects post Sucrose drink challenge:

Post sucrose drink plasma glucose levels considerably increased in placebo treated subjects (n=20) with iCmax 51.3±5.8 mg/dL and iAUC _{(0-90 min)} 2266 mg/dL × min at Tmax 30 min when compared to the baseline (T 0min). However, in Glubloc™ treated subjects (n=20), significantly low plasma glucose levels were observed with Cmax 21.9±4.7 mg/dL and iAUC _{(0-90 min)} 859 mg/dL × min at Tmax 30 minutes when compared to the baseline (T 0min).

Table 2: Descriptive statistics for placebo and Glubloc™ post 70g of sucrose drink intake.

	iAUC _(0-60min)	iCMax	Tmax
	[mg/dL × min]	[mg/dL]	[min]
Placebo	2266	51.3±5.8	30
Glubloc™	859	21.9±4.7	30

High glycaemic index (GI) foods like cooked rice and sucrose can have a significant impact on blood glucose and insulin response. These types of foods are quickly absorbed by the body and cause a rapid increase in blood sugar levels. As a result, the pancreas releases a large amount of insulin in order to bring blood sugar levels back to normal. This sudden surge of insulin can cause blood sugar levels to drop too low, leading to feelings of fatigue and hunger. Over time, this rollercoaster effect on blood sugar and insulin can lead to the development of insulin resistance and potentially even type 2 diabetes. In addition, high GI foods may also increase the risk of heart disease and other health problems. It is generally recommended to choose foods with a lower GI in order to maintain stable blood sugar levels and support overall health.

Flavonoids and imino sugars, such as 1-deoxynojirimycin (DNJ), fagomine, and 2-O-α-D-galactopyranosyl deoxynojirimycin from Morus alba L extracts have shown to temporarily block the carbohydrate digestive enzymes alpha-glucosidase, resulting in a reduction in blood glucose levels^7,13,15. This effect is reversible and only lasts for 1–2 hours, making it a safe and effective way to regulate blood glucose levels. In addition to blocking the alpha-glucosidase enzyme, Malus domestica rind extracts have shown to block SGLT-2 mediated glucose transport from the intestinal lumen^5,6. These effects may be particularly useful in the management of blood glucose and insulin spikes and other metabolic conditions. Glubloc™ comprise a combination of flavonoid rich extracts of Morus alba and Malus domestica to specifically target the digestive enzymes (alpha-glucosidase and alpha- amylase) and the glucose transporter SGLT-2 in the intestine.

In this study Glubloc™ administration 10 min prior to the carbohydrate rich rice meal or a sugar heavy drink, in healthy individuals suppressed the rapid glucose surge by blocking its uptake from the intestine. In both the rice meal study and sucrose intake study Glubloc™ reduced overall uptake of glucose as indicated by significantly low iAUC values (1063 and 859 mg/dL × min in Glubloc™ treated group compared to 5090 and 2266 mg/dL × min in placebo treated group). The impact of Glubloc™ on reduction in blood glucose levels in rice meal study and sucrose study were ~ 4.5 and ~ 2.5 fold, respectively, when compared to placebo group. Moreover, Glubloc™ treated individuals avoided glucose crash post sucrose drink intake as depicted in the Fig. 2. During the conduct of the study no side effects or adverse events were recorded.

These findings indicate that Glubloc™ has the potential to reduce the rapid surge in blood glucose levels due to intake of high glycaemic index complex carbohydrate foods and beverages containing table sugar or sucrose. Glubloc™ can help maintain low and steady levels of blood glucose in individuals consuming carbohydrate heavy meals or sucrose drinks, thereby avoiding the negative effects of glucose and insulin surge.

Our findings provide preliminary evidence for the efficacy and safety of Glubloc™ and warrant further investigations in larger randomized placebo led trials with longer follow-up periods and more diverse populations to confirm our findings.

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Ethics approval and consent to participate: The study protocol was approved by the internal ethics committee and the institutional review board of My Pura Vida Wellness Center (Approval no: MPV/IEC/PS/2021-2022/02). Written informed consent was obtained from all the study participants. All procedures were in accordance with the ethical standards of the responsible committee on human experimentation and with the Helsinki Declaration.

Consent for publication Not Applicable

Availability of data and materials The datasets used and/or analysed during the current study are available from the corresponding author (email: [email protected] or [email protected]) on reasonable request.Competing interests All co-authors declare that they have no conflict of interest.

Funding Not Applicable

Authors' contributions Dr Chaitanya Chakravarthi Gali conceptualized and designed the study. Dr Lalitha Palle recruited the participants for the study, explained the procedures and acquired the informed consent from the fellow participants. Dr Chaitanya Gali and Dr Lalitha Palle performed the experiments, analyzed the data sets and wrote the paper.

Acknowledgements We acknowledge all the fellow participants' time and their invaluable contribution for the study.

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Version 2

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You are reading this latest preprint version

Glubloc™ Reduces Postprandial Blood Glucose Surge in Healthy Individuals (A Placebo Controlled Pilot study).

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Abstract

Figures

1. Introduction

2. Methods

Selection of subjects and treatment schedule:

Statistical analysis:

Study Flowchart:

Rice meal study design:

Sucrose drink study design:

3. Results

Glubloc™ treatment reduced post prandial glucose response (PPGR) in healthy subjects post carbohydrate rich meal intake:

Glubloc™ treatment reduced post prandial glucose response (PPGR) in healthy subjects post Sucrose drink challenge:

4. Discussion

References

Additional Declarations

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