The effect of nutraceutical supplements (Thompson’s Super Bioflavonoid Complex 'Registered Trademark') on blood glucose levels in prediabetes and type 2 diabetes- A pilot study

Status

Not yet recruiting

Phases

Phase 1

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12617000361303

Enrollment

100

Registered

2017-03-08

Start date

2019-10-01

Completion date

2020-04-30

Last updated

2019-07-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

This study will investigate the potential of commercially available nutraceutical supplement (Thompson’s Super Bioflavonoid Complex 'Registered Trademark') is similar to the dipeptidyl peptidase-4 (DPP-4) inhibitor group, also known as gliptins, which are second line anti-diabetic drugs after metformin and sulfonylureas. The gliptins block the action of DPP-4, an enzyme which inhibits a group of gastrointestinal hormones called incretins which stimulate the production of insulin post meal and reduce the production of glucagon by the liver during digestion. DPP-4 inhibitors help regulate blood glucose levels by inhibiting incretins reducing the financial burden for antidiabetic medicine equivalent to AU$193.8 million per year. This study aim:- To determine the effect of nutraceutical supplement (Thompson’s Super Bioflavonoid Complex 'Registered Trademark') as natural DPP-4 inhibitor on glycemic control in patients with type 2 diabetes mellitus. The study will include a total of 80 T2D participants recruited from the community. After an overnight fast (12-hr), participants will attend the clinical areas of the Medical Science Precinct, and the School of Health Sciences, University of Tasmania (UTAS) to undergo the following: 1) Medical & lifestyle questionnaires 2) Anthropometrics 3) Blood tests to measure blood glucose, HbA1c, serum lipids, insulin, & oxidative markers. 4) Glucose metabolism (2hr oral glucose tolerance test). 5) Hemodynamic measures (blood pressure, heart rate & ECG). 6) Urinary electrolytes & kidney function. 7) Pregnancy test for woman during their reproductive life. Venous blood & urine samples will be collected at the start and end of the two phases of the study. Nutraceutical supplements will be provided to the participants for 12 weeks. These natural products possess anti-diabetic activities & the suggested course of supplements will maintain a constant level of dosage of these nutraceutical supplements to improve the overall metabolic functions in T2D cohort. Biomarkers of metabolic response included in this study include measuring 8-hydroxy deoxyguanosine (8-OHdG) (oxidative DNA damage), total lipid peroxidation (lipid peroxidation) & resistin (adipocytokine response).

Interventions

This study will investigate the potential of commercially available nutraceutical supplements (Thompson’s Super Bioflavonoid Complex 'Registered Trademark') similar to the dipeptidyl peptidase-4 (DPP-4) inhibitor group, also known as gliptins, which are second line anti-diabetic drugs after metformin and sulfonylureas. This study has one intervention: Intervention 1 (week zero to week 12): To use nutraceutical supplement (Thompson’s Super Bioflavonoid Complex 'Registered Trademark') as natural DPP-4 inhibitor in patients with type 2 diabetes mellitus. Thompson’s Super Bioflavonoid Complex 'Registered Trademark': Active Compounds: Citrus bioflavonoid extract, ascorbic acid, rutin, sodium ascorbate. Composition: Citrus Bioflavonoid Extract-500 mg; Ascorbic Acid- 390 mg; Rutin- 100 mg; Sodium ascorbate- 125.3 mg. Number of Tablets in each pack: 120 Mode of Administration: Two tablets per day before/with meal (NOT AFTER MEAL) Strategies used to monitor adherence to the intervention: Participants will be asked to complete a logbook to record the day and time they take the tablets.

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Treatment

Masking

Blinded (masking used) (Subject)

Eligibility

Sex/Gender

All

Age

25 Years to 75 Years

Healthy volunteers

Inclusion criteria

For all participants 1. Have been clinically diagnosed with type 2 diabetes. 2. Aged between (25 and 75) years. 3. Lean, overweight or obese (BMI 19 to 35 kg/m2). 4. Have normal or controlled blood pressure. 5. Normotensive (seated brachial blood pressure less than 140/90 mmHg). 6. Have given signed informed consent to participate in the study. 7. Clinically diagnosed T2D on diet and lifestyle intervention or metformin only treatment (e.g. fasting plasma glucose equal or more than 7.0mM, HbA1c). 8. Willing to take nutraceutical supplements (Thompson’s Super Bioflavonoid Complex 'Registered Trademark' and Thompson’s Cholesterol Manager 'Registered Trademark'), for 12 weeks. 9. Negative pregnancy test for the woman during their reproductive life.

Exclusion criteria

For all participants 1. Age less than 25 yrs or more than 75 yrs 2. Morbidly obese with a BMI equal or more than 35 kg/m2 3. Not on diet and lifestyle or metformin only treatment for their diabetes (e.g. insulin injections, sulphonylureas, GLP-1 receptor agonists). 4. History of myocardial infarction or stroke 5. History of malignancy within past 5 years (except for non-melanoma skin cancers) 6. Identification of any medical condition requiring immediate therapeutic intervention 7. Uncontrolled hypertension (resting brachial blood pressure equal or more than 160/100 mmHg) 8. History of severe liver disease 9. History of drug or alcohol abuse 10. Elective major surgery during the course of the study 11. Pregnancy and/ or lactation 12. Currently consuming nutraceutical supplements (especially vitamin C and D) 13. Participation or intention to participate in another clinical research study during the study period. 14. Not willing to take nutraceutical supplements (Thompson’s Super Bioflavonoid Complex 'Registered Trademark' and Thompson’s Cholesterol Manager 'Registered Trademark'), for 12 weeks. 15. Positive pregnancy test for the woman during their reproductive life. 16. Participants with impaired renal function.

Outcome results