Safety evaluation and effect of food supplement containing dietary fiber from cassava on the alterations of physiological parameters in overweight female volunteers

Phase 1

Completed

• Conditions: Healthy conditions; fasting blood sugar; HbA1c; lipid profile; atherosclerosis index (AI)

• Registration Number: TCTR20190521001
• Lead Sponsor: ational Research Council of Thailand

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Completion: 2019-02-07
• Study Start: 2019-05-21
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Female
• Target Recruitment: 75

Inclusion Criteria

- Live in Khon Kaen, Thailand
- Aged between 35-60 years old
- Body mass index more than 23
- blood pressure less than 140/90 mmHg
- Fastig plasma glucose less than 100 mg/dL
-All volunteers should not use other nutraceutical compounds or herbs or drugs
which influenced on the nervous system function and bone at least 3 months before participating in this study
- On the day of the study, all volunteers felt well and refrain from drinking tea or
coffee, or alcohol

Exclusion Criteria

• Cardiovascular disease
• Respiratory disease
• Neuropsychological disorders
• Diabetes
• Liver disease
• Renal disease
• Endocrine dysfunction
• Autoimmune disease

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Body mass index 4 weeks equipment

Secondary Outcome Measures

Name	Time	Method
clinical chemistry 4 weeks clinical laboratory,Complete blood count 4 weeks clinical laboratory,Homeostasis Model Assessment Insulin Resistance (HOMA-IR) 4 weeks clinical laboratory,atherosclerosis index (AI) 4 weeks clinical laboratory,Roseburia Blautia, Eubacterium rectale and Faecalibacterium prausnitzii 4 weeks clinical laboratory,bifidobacteria spp and Lactobacilli spp 4 weeks clinical laboratory