A Placebo-Controlled, Randomized, Safety and Efficacy Study to Evaluate the Change in Hemoglobin A1c Levels in Type 2 Diabetic Subjects While Taking Nutralin

A Phase II, Placebo-Controlled, Randomized, Safety and Efficacy Study to Evaluate the Change in Hemoglobin A1c Levels in Type 2 Diabetic Subjects While Taking Nutralin

Status

Withdrawn

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01275027

Enrollment

Registered

2011-01-12

Start date

2011-01-31

Completion date

2011-08-31

Last updated

2015-04-22

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

Conditions

Diabetes

Keywords

diabetes, blood sugar, insulin, nutritional supplement, nutraceutical

Brief summary

The purpose of this clinical research study is to evaluate the effects an investigational food product has on the blood sugar and insulin levels in individuals with diabetes.

Detailed description

The investigational product has helped decrease the amount of insulin needed in treating diabetic dogs and has improved the dogs' longevity and quality of life. Observational analysis by trained veterinarians has indicated that the natural fluctuations in blood glucose levels do not exist in dogs consuming the product. An initial Phase 1 study tested the product in a brownie form. The product has been reformulated to capsule form for the Phase 2 study. The hypothesis for this study is that diabetic individuals will decrease their insulin/diabetic medication usage and have a decrease in glucose levels after consuming the product for 16 weeks.

Interventions

DIETARY_SUPPLEMENTNutralin

7 capsules taken 15 minutes before each of the three main meals of the day

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Men and women who are at least 18 years old * Diagnosis of Type 2 Diabetes * Has been on stable diabetes medication/insulin for the past three months

Exclusion criteria

* Women who are pregnant, breastfeeding or planning to become pregnant * Diagnosis of Celiac Disease or gluten intolerance * Current or active kidney disease * Current or active liver disease * Any food allergies

Design outcomes

Primary

Measure	Time frame	Description
Blood Sugar	16 weeks	blood sugar levels
HgA1c reduction	16 weeks	reduction of Hemoglobin A1c levels

Secondary

Measure	Time frame	Description
Diabetes medication	16 weeks	reduction in the amount of diabetes medication needed

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026