Safety evaluation and effect of consumption of pineapple byproduct as cider to reduce the risk of metabolic disorders

Phase 1

Completed

• Conditions: Healthy conditions; Pineapple cider; vinegar; metabolic disorders; lipid profiles

• Registration Number: TCTR20210616007
• Lead Sponsor: ational Research Council of Thailand (NRCT)

Brief Summary

The subjects of Cider group show increase activity anti-oxidant enzyme; SOD with significantly different when compare with placebo group.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-06-16
• Study Completion: 2022-11-21
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

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

Inclusion Criteria

1. Aged between 35-60 years old 2. Body Mass Index (BMI) more than 23 kg/m2

Exclusion Criteria

1. Volunteers who have been diagnosed with one of the following; cardiovascular diseases, respiratory diseases, neuropsychological diseases, liver disease (AST more than 64 U/L, ALT more than 50 U/L), Kidney disease (estimate GFR less than 90 ml/min), autoimmune disease, hematological disorder, and cancer 2. Volunteers who require supplements or any drug that affect the nervous system by order of the doctor before trial 3. Volunteers who use supplements or any drug that affect the body weight, glucose, and lipid level before trial 4. Smoking more than 10 pieces/ day 5. Drinking alcohol more than 5 times/ day 6. Volunteers who participate in other projects 7. Pregnancy or lactating women 8. Blood pressure less than 140/90 mm Hg and Fasting Blood Sugar (FBS) after fasts for 8 hours less than 126 mg/d

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Metabolic parameters include Homeostasis Model Assessment Insulin Resistance (HOMA-IR) index, Atherosclerosis index (AI Index) , Atherogenic index of plasma (AIP), and Insulin 8 weeks Laboratory

Secondary Outcome Measures

Name	Time	Method
The changes of hematological and clinical chemistry parameters 8 weeks Laboratory,Oxidative stress markers include Malondialdehyde (MDA), Superoxide dismutase (SOD), Catalase (CAT), and Glutathione peroxidase (GSH-Px) 8 weeks Laboratory,Angiotensin converting enzyme (ACE) 8 weeks Elisa method,Advanced glycation end products (AGEs) 8 weeks Elisa method,Urinalysis 8 weeks Laboratory, Homocysteine 8 weeks Laboratory,Body Composition, Body Mass Index (BMI), and Anthropometry 8 weeks Equipment,The changes of electrocardiogram 8 weeks Electrocardiography