Fibrelite Powder

Fiber Powder

Contains Wheat Dextrin, Guar Gum, Resistant Maltodextrin, Inulin

Each sachet of 10 grams (per serve) contains:

Dietary fiber (Soluble fiber) …………………. 6.67 gram

Ingredients:

Wheat Dextrin, Resistant Maltodextrin, Inulin, Guar Gum

Sachets (10 gm powder)

4.1 Therapeutic Indication

Dietary Management of Diabetes

4.2 Posology and method of administration

Recommended Usage: 10 g (1 sachet) a day or as suggested by a healthcare professional.

Recommended duration of use: Depends upon physiological condition of the individual.

Instructions for Use: Add whole sachet of 10 g powder in 200 ml water. Stir well and use promptly. Consume whole sachet at once.

NOT FOR MEDICINAL USE

Flavour: Orange Flavour

Individual clinical data of components of “Fibrelite” is promising to promote a healthy lifestyle and prevent metabolic diseases, e.g. diabetes mellitus, obesity, and dyslipidaemia.

4.3 Contraindications

Hypersensitivity to active ingredients or to any of the excipients.

4.4 Special warnings and precautions for use

Allergens: Contains Wheat. It may contain Milk, Soy and Nuts.

The product should not be taken dry and should always be taken mixed with fluid.

4.5 Drugs interactions

4.6 Use in special populations

Pregnant / lactating women, children and people with medical conditions should consult a healthcare professional before use.

4.7 Effects on ability to drive and use machines

Fibrelite has no or negligible influence on the ability to drive and use machines.

4.8 Undesirable effects

Polyols (non-digestible carbohydrates in Fibrelite) may have laxative effects.

Common side effects include: GI discomfort or nausea, Bloating, Gas, Stomach Cramps, Diarrhea. Gradually increasing fiber intake and drinking plenty of water can help minimize these side effects.

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via email to: medico@zuventus.com Website: Website: https://www.zuventus.com/drug-safety-reporting

4.9 Overdose

Symptoms: Overdose with soluble fibres may cause abdominal discomfort, flatulence and intestinal obstruction.

Management: Adequate fluid intake should be maintained and management should be symptomatic.

5.1 Mechanism of Action

Resistant Maltodextrin

Resistant Maltodextrin (resistant starch) is a starch fraction that is indigestible in the small intestine but is fermented in the colon by colonic microbiota (bacteria), resulting in enhanced short-chain fatty acid (SCFA) production. Several health benefits are obtained from the fermentation of resistant starch in the colon, e.g. weight control, blood glucose reduction, insulin sensitivity, triacylglycerol reduction, and appetite regulation.

Resistant maltodextrin helps to maintain blood and lipid profiles as well as promote satiety and reducing food intake. Studies have demonstrated the beneficial effects of resistant maltodextrin on body weight, body composition, satiety, and food intake.

Inulin

Inulin is a water soluble storage polysaccharide belong to a class of dietary fibers known as fructans (non-digestible carbohydrates). Inulin functions as a prebiotic, promote the proliferation of the beneficial lactic acid-producing Bifidobacteria and Lactobacillus species in gut.

Inulin have been found to be effective in the stabilization of glycemic response and have positive effects on lipid metabolism by absorbing bile salts from small intestine. Inulin is a soluble fiber which is not digested by human enzymes and produces distinctive fiber-alike results on the effectiveness of the gut, thus, lowering the pH of intestine, providing assistance in relieving constipation and increasing stool load or rate (bulking effect).

Wheat Dextrin

It is a carbohydrate, which is not digested in small intestine but slowly fermented in the large intestine, does not raise blood sugar or insulin levels. Wheat dextrin aids in reducing the glycemic load of a meal containing carbohydrates.

Through the production of SCFAs, wheat dextrin stimulates pancreatic insulin release and affect liver control of glycogen breakdown, and effective in decreasing glucose and insulin levels and improving glycemic and insulinemic indices. Long-term assessment of wheat dextrin supplementation demonstrated a trend towards better weight maintenance compared with baseline. Also wheat dextrin increases the fecal/stool output.

Hydrolysed Guar Gum

The fermentation of partially hydrolyzed guar gum in colon produces Short Chain Fatty Acids (SCFA), which is responsible for their clinical effects. Several SCFA have shown their growth stimulatory effects on lactic acid bacteria and Bifidobacterium spp. Usefulness of partially hydrolysed guar gum has been studied in many clinical situations, e.g. diabetes, hypercholesterolemia, bacterial overgrowth etc. with promising results.

Administration of partially hydrolysed guar gum (PHGG) induces beneficial impact on hyperglycaemia, hyperlipidaemia and incretins metabolic hormones. It reduces LDL cholesterol, whereas HDL level was significantly increased therefore reducing the risk of metabolic syndrome. Partially hydrolyzed guar gum can also act as a prebiotic.

5.2 Pharmacodynamic properties

Fibrelite is a special blend, which slows down digestion and provides satiety for a longer period. It is a low-calorie formula, which provides the required fibre important for digestive health. Proposed usage are for dietary management of prediabetes and diabetes. Evidence from clinical trials demonstrate that the individual components of Fibrelite e.g. resistant maltodextrin, inulin, wheat dextrin, hydrolyzed guar gum have been shown to be a promising alternative that can help promote a healthy lifestyle and prevent metabolic diseases, e.g. Diabetes Mellitus, Obesity, Dyslipidaemia and Constipation.

5.3 Pharmacokinetic properties

Absorption and Digestion: Soluble fiber is not digested in the small intestine. Instead, it absorbs water and forms a gel-like substance, which slows down digestion and helps regulate blood sugar levels.

Fermentation: In the large intestine, soluble fiber is fermented by gut bacteria. This process produces short-chain fatty acids (SCFAs) like acetate, propionate, and butyrate, which have various health benefits, including anti-inflammatory effects and improved gut health.

Metabolism: The SCFAs produced during fermentation are absorbed into the bloodstream and can be used as an energy source by the body. They also play a role in regulating metabolism and appetite.

Excretion: Any unfermented fiber is excreted in the stool, contributing to bulk and aiding in regular bowel movements. These properties make soluble fiber beneficial for managing blood sugar levels, cholesterol, and overall digestive health.

6.1 Animal Toxicology or Pharmacology

Not available

Fibrelite is a “Nutraceutical” a substance that may be considered food or part of a food which provides health benefits, encompassing prevention and treatment of disease. Fibrelite is 100% natural soluble fiber from plant origin (vegan). Fibrelite is a blend of soluble fibres, which helps in improving the health and overall well-being. It comprises of Resistant Maltodextrin, Inulin, Wheat Dextrin and Partially Hydrolysed Guar Gum that is formulated to improve the colon health and support the good bacteria in the digestive system.

8.1 Incompatibilities

None

8.2 Shelf-life

Refer on pack.

8.3 Packaging information

10 tablets in each blister strip

8.4 Storage and handing instructions

Storage: Store below 30°C.

Protect from light and moisture Keep out of reach of children.

• Fiber helps to restore normal digestive health.
• Polyols, present in Fibrelite may have laxative effects.
• Pregnant / lactating women, children and people with medical conditions should consult a healthcare professional before use.
• This product is not intended to diagnose, treat, cure or prevent any disease(s).

15th October 2024