Study to Evaluate Safety and Efficacy of PreCrea® on Subjects With Higher Than Normal Blood Sugar Levels (Precrea)

Joe Fenn

Status and phase: Completed; Phase 3

Conditions: Hyperglycemia; Diabetes Mellitus; Pre-Diabetes; Metabolic Syndrome

Treatments: Dietary Supplement: Study dietary supplement (PreCrea 600 mg capsules); Dietary Supplement: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT02189005

Precre/Nutra001/PMI13

Details and patient eligibility

About

The purpose of the study is to evaluate the efficacy and safety of PreCrea® on subjects with higher than normal blood sugar levels.

Full description

A Prospective, Double Blind, Placebo-Controlled, Randomized, Multicentric, study to evaluate the efficacy and safety of PreCrea®, a twice-daily dietary supplement in people with higher than normal blood sugar levels.

Enrollment: 210 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Age ≥ 18 years to ≤ 65 years
2. Newly diagnosed Male or Female participants with higher than normal blood sugar levels (FPG >100 mg/dL) on of Pre-Diabetes and Diabetes Mellitus during screening and not on any treatment
3. Ability to understand and willingness to sign and date a written Informed Consent Document at the screening visit before any protocol- specific procedures are performed and willing to adhere to the protocol and entire trial procedures

Exclusion criteria

1. Subjects with Type 1 Diabetes Mellitus
2. Participants on insulin therapy and other oral anti-diabetic agents or having uncontrolled diabetes.
3. Stroke, myocardial infarction, coronary artery bypass graft (CABG) percutaneous transluminal coronary angioplasty (PTCA) or angina pectoris within the last 12 months.
4. Cardiac status New York Heart Association class III-IV
5. Uncontrolled blood pressure > 150 mmhg systolic and > 100 mmhg diastolic
6. Impaired renal function as shown by but not limited to serum creatinine ≥ 1.5 mg/dl for males and ≥ 1.4 mg/dl for female
7. Clinically significant peripheral edema
8. Clinical evidence of active liver disease or serum alenine aminotransferase (ALT) or aspartate amino transferase (AST) 2.5 times the upper limit of the normal range (2.5 X ULN)
9. Participants on steroid
10. Pregnancy or lactating women
11. Known hypersensitivity to any of the study drugs
12. Any malignancy within the last 5 years, with exception of adequately treated basal or squamous cell carcinoma of the skin or adequately treated carcinoma insitu.
13. Current addiction or current alcohol abuse or history of substance or alcohol abuse within the last 2 years
14. Subject is the investigator or any sub-investigator, research assistant, pharmacist, study coordinator, other staff or relative thereof directly involved in the conduct of the protocol
15. Mental condition rendering the subject unable to understand the nature, scope and possible consequences of the study. Subject unlikely to comply with protocol e.g. uncooperative attitude, inability to return for follow up visits and unlikelihood completing of the study.
16. Any disease or condition that in the opinion of the investigator and/or sponsor may interfere with the completion of the study.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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210 participants in 2 patient groups, including a placebo group

PreCrea

Experimental group

Description:

Study dietary supplement (Precrea 600 mg capsules) will be given to subjects twice daily 30 mins before food for 90 days along with life style modification program.

Treatment:

Dietary Supplement: Study dietary supplement (PreCrea 600 mg capsules)

Placebo 600 mg capsules

Placebo Comparator group

Description:

Placebo was given to patients twice daily 30 mins before food for 90 days along with lifestyle modification program.

Treatment:

Dietary Supplement: Placebo