Effectiveness of Pumpkin Seed Extract on Improving Blood Sugar Level in Subhealth Subjects

Study Overview
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Brief Summary
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This randomized, double-blind, placebo-controlled, and parallel clinical study aims to investigate the effectivness of a pumpkin seed extract on blood sugar management in subhealth people.

Official Title
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Effectiveness of Pumpkin Seed Extract on Improving Blood Sugar Level in Subhealth Subjects

Conditions
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Diabetes, Metabolic Disease

Intervention / Treatment
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* Dietary Supplement: Pumpkin seed extract (Low dose)
* Dietary Supplement: Pumpkin seed extract (High dose)
* Dietary Supplement: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Fasting blood sugar levels from 100 to 125 mg/dL Glycated hemoglobin levels from 5.7 to 6.4% 2-hour OGTT levels from 140 to 199 mg/dL Exclusion Criteria: Pregnant women or preparing for pregnancy. Lactating women. Women gave birth 6 months before the study. Poor kindy funciton Severe cardiovascular or other chronic diseases Patients with type I or II diabetes Poor compliance Alcohol abuser Using anti-diabetic or weight managent supplements Blood transfusion three months before the study Pumpkin seed allergy

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo group<br>Placebo capsule, one capsule/day (300 mg/day) for 3 months | Dietary Supplement: Placebo<br>* Placeo (300 mg/day)<br>|
| Experimental: Low dose<br>Pumpkin seed extract capsule, one capsule/day (300 mg/day) for 3 months | Dietary Supplement: Pumpkin seed extract (Low dose)<br>* Pumpkin seed extract standardized with specific peptides (300 mg/day)<br>|
| Experimental: High dose<br>Pumpkin seed extract capsule, two capsules/day (600 mg/day) for 3 months | Dietary Supplement: Pumpkin seed extract (High dose)<br>* Pumpkin seed extract standardized with specific peptides (600 mg/day)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Biochemical analysis | Changes in fasting blodd sugar levels of 60 pariticpants will be analyzed between baseline and week 12. | Baseline up to 12 weeks | 
| Biochemical analysis | Changes in glycosylated hemoglobin levels of 60 pariticpants will be analyzed between baseline and week 12. | Baseline up to 12 weeks | 
| Biochemical analysis | Changes in insulin levels of 60 pariticpants will be analyzed between baseline and week 12. | Baseline up to 12 weeks | 
| Biochemical analysis | Changes in incremental area under the curve for glucose for 60 pariticpants will be analyzed between baseline and week 12. | Baseline up to 12 weeks | 
| Hormone analysis | Changes in GLP-1 levels of 60 pariticpants will be analyzed between baseline and week 12. | Baseline up to 12 weeks | 
| Hormone analysis | Changes in DPP4 levels of 60 pariticpants will be analyzed between baseline and week 12. | Baseline up to 12 weeks | 
| Hormone analysis | Changes in adiponectin levels of 60 pariticpants will be analyzed between baseline and week 12. | Baseline up to 12 weeks |