Effect of dietary supplements on type 2 diabetes

Clinical study on the effect of BiotiQuest™ Sugar Shift and Kesto Mix dietary supplements on the treatment of type 2 diabetes mellitus

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN48974890

Enrollment

Registered

2022-11-09

Start date

2022-08-01

Completion date

Unknown

Last updated

2026-03-02

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

Conditions

Type 2 diabetes mellitus Nutritional, Metabolic, Endocrine Type 2 diabetes mellitus

Interventions

The included patients are assigned to two treatment groups by randomization: Group A (study or experimental): Sugar Shift (SS) Group B (control): placebo Assignment to treatment groups is carried out

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Patients diagnosed with T2DM 2. Between 30 and 65 years old 3. Body mass index (BMI) between 28-40 kg/m² at baseline 4. Attended the diabetes specialized consultations of the Hermanos Ameijeiras Hospital 5. Gave their consent to participate in the study

Exclusion criteria

Exclusion criteria: 1. Chronic kidney disease 2. Onco-proliferative diseases 3. Pregnant women

Design outcomes

Primary

Measure	Time frame
Hemoglobin A1c (Hb-A1c) (%) determined in K3EDTA blood collection tubes at the beginning of the study (Day 1) and the last day (Day 84)	—

Secondary

Measure	Time frame
1. Fasting blood glucose (FBG) determined in serum samples every 28 days (day 1, day 28, day 56 and day 84) 2. Postprandial glucose (2 hours) determined in serum samples every 28 days (day 1, day 28, day 56 and day 84) 3. Cholesterol determined in serum samples at the beginning of the study (Day 1) and the last day (Day 84) 4. Triglycerides determined in serum samples at the beginning of the study (Day 1) and the last day (Day 84) 5. HDLc determined in serum samples at the beginning of the study (Day 1) and the last day (Day 84) 6. LDLc determined in serum samples at the beginning of the study (Day 1) and the last day (Day 84) 7. Insulin determined in serum samples at the beginning of the study (Day 1) and the last day (Day 84) 8. Creatinine determined in serum samples at the beginning of the study (Day 1) and the last day (Day 84) 9. LPS: Endotoxin units / mL determined in serum samples at the beginning of the study (Day 1) and the last day (Day 84) 10. Microbiome analysis: 16S amplicon sequencing determined in fecal samples at the beginning of the study (Day 1) and the last day (Day 84)	—

Measure

Time frame

1. Fasting blood glucose (FBG) determined in serum samples every 28 days (day 1, day 28, day 56 and day 84) 2. Postprandial glucose (2 hours) determined in serum samples every 28 days (day 1, day 28, day 56 and day 84) 3. Cholesterol determined in serum samples at the beginning of the study (Day 1) and the last day (Day 84) 4. Triglycerides determined in serum samples at the beginning of the study (Day 1) and the last day (Day 84) 5. HDLc determined in serum samples at the beginning of the study (Day 1) and the last day (Day 84) 6. LDLc determined in serum samples at the beginning of the study (Day 1) and the last day (Day 84) 7. Insulin determined in serum samples at the beginning of the study (Day 1) and the last day (Day 84) 8. Creatinine determined in serum samples at the beginning of the study (Day 1) and the last day (Day 84) 9. LPS: Endotoxin units / mL determined in serum samples at the beginning of the study (Day 1) and the last day (Day 84) 10. Microbiome analysis: 16S amplicon sequencing determined in fecal samples at the beginning of the study (Day 1) and the last day (Day 84)

—

Countries

Cuba

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Mar 14, 2026