Efficacy of fiber-multivitamin combination on glycemic control, lipid profiles and body composition in overweight/obese adults with impaired fasting glucose.

Phase 1

• Conditions: Diabetes is a major social burden. In 2017, the International Diabetes Federation estimated that more than 425 million people are currently affected by diabetes, and forecast that this number will alm; fiber- multivitamin combination, glycemic control, lipid profiles, %body fat, adults with impaired fasting glucose

• Registration Number: TCTR20180618001
• Lead Sponsor: nicity Science

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2018-06-18
• Study Completion: 2019-01-01
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Pending (Not yet recruiting)
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

-BMI 23-35 kg/m2
-waist circumference > 80 cm in female or > 90 cm in male
-Impaired fasting glucose screening by
* fasting blood glucose levels between 6.1 and 7.0 mmol/L (110 and 125 mg/dL)
* 2-hour Glucose Tolerance Test with 75 g of oral glucose dose, blood plasma glucose between 7.8 mmol/L (140 mg/dL) and 11.1 mmol/L (200 mg/dL)
-No anti-diabetic and lipid-lowering therapy
-Stable body weight for at least 6 mo

Exclusion Criteria

-Pregnant or lactating females
-Persons with known allergies to any ingredients in either the active or placebo study compounds will be also excluded.
-People who habitually used a dietary fiber supplement will be also excluded.
-Following, or recently followed, a diet plan or supplement or medication use known to affect the trial
- Anyone who has had a history of diagnosed type 2 diabetes mellitus, gastrointestinal disease, poorly controlled hypertension (systolic blood pressure > 160 mmHg, diastolic blood pressure > 100 mmHg), renal disease, liver disease, and thyroid disease, as well as severe health condition (e.g., cancer, cardiovascular disease).
- participating in any vigorous exercise program

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
fasting blood glucose 12 weeks after end of the intervention the automated (enzymatic) method

Secondary Outcome Measures

Name	Time	Method
fasting insulin 12 weeks after end of the intervention Chemiluminescence immunoassay (CLIA),blood lipid profiles 12 weeks after end of the intervention Enzymatic colorimetric method,% body fat (body composition) 12 weeks after end of the intervention DXA (Dual X-ray absorptometry)