NCT04013490

Brief Summary

This study is set up to determine the consumption safety and the effect of a food supplement containing dietary fiber from cassava on the alterations of physiological parameters including fasting blood sugar, HbA1c, insulin resistance, lipid profiles, atherogenic index, blood pressure and gut microbes in overweight female volunteers.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
75

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Feb 2019

Shorter than P25 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 27, 2019

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

June 20, 2019

Completed
19 days until next milestone

First Posted

Study publicly available on registry

July 9, 2019

Completed
22 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2019

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2019

Completed
Last Updated

February 21, 2020

Status Verified

February 1, 2020

Enrollment Period

5 months

First QC Date

June 20, 2019

Last Update Submit

February 20, 2020

Conditions

Overweight

Keywords

physiological parametersconsumption safetycassavafood supplementoverweight female

Outcome Measures

Primary Outcomes (2)

  • The fasting blood sugar level

    The previous study reported that high dietary fiber could decrease the fasting blood sugar in type 2 diabetes patient. The overweight female volunteer receive food supplement containing dietary fiber from Cassava should show the lower level of fasting blood sugar than the placebo-treated group after 4 weeks of intervention.

    Baseline and 4 weeks of intervention

  • The atherogenic index

    The atherogenic index is an index composed of triglycerides and high-density lipoprotein cholesterol. It has been used to quantify blood lipid levels and commonly used as an optimal indicator of dyslipidemia and associated diseases. The food supplement containing dietary fiber from Cassava might be able to decrease the atherogenic index in overweight female volunteer. The overweight female volunteer receive food supplement containing dietary fiber from Cassava should show the lower number of the atherogenic index than the placebo-treated group after 4 weeks of intervention.

    4 weeks of intervention

Secondary Outcomes (12)

  • hemoglobin A1c concentration

    4 weeks of intervention

  • Homeostasis model assessment-insulin resistance (HOMA-IR)

    4 weeks of intervention

  • Low-density lipoprotein (LDL) concentration

    4 weeks of intervention

  • High-density lipoprotein (HDL) concentration

    4 weeks of intervention

  • Triglyceride (TG) concentration

    4 weeks of intervention

  • +7 more secondary outcomes

Study Arms (3)

Placebo capsule

PLACEBO COMPARATOR

Subject receive the Placebo product for 4 weeks.

Dietary Supplement: Cassava dietary fiber capsule

Cassava dietary fiber capsule 1.5 g/day

ACTIVE COMPARATOR

Subjects receive Cassava dietary fiber capsule at the dose of 1.5 g/day for 4 weeks.

Dietary Supplement: Cassava dietary fiber capsule

Cassava dietary fiber capsule 3 g/day

ACTIVE COMPARATOR

Subjects receive Cassava dietary fiber capsule at the dose of 3 g/day for 4 weeks.

Dietary Supplement: Cassava dietary fiber capsule

Interventions

Cassava dietary fiber capsuleDIETARY_SUPPLEMENT

Cassava dietary fiber capsule or placebo will be consumed once daily at the recommended doses of each group.

Cassava dietary fiber capsule 1.5 g/dayCassava dietary fiber capsule 3 g/dayPlacebo capsule

Eligibility Criteria

Age35 Years - 60 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy women age between 35-60 years old
  • BMI 23-29.99
  • Blood pressure \<140/90 mmHg
  • Fasting plasma glucose \< 100 mg/dL

You may not qualify if:

  • Presence of any chronic diseases
  • Alcohol addict or consume more than 2 units/day
  • Smoking more than 10 cigarettes per day
  • Medication or herbal medicine usage within 1 month prior to the study
  • Use any medication or food supplement which affect to outcomes
  • Pregnant or breastfeeding women
  • Athlete

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Jitanaporn Wattanathorn

Khon Kaen, 40002, Thailand

Location

MeSH Terms

Conditions

Overweight

Condition Hierarchy (Ancestors)

OvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associated Professor

Study Record Dates

First Submitted

June 20, 2019

First Posted

July 9, 2019

Study Start

February 27, 2019

Primary Completion

July 31, 2019

Study Completion

August 31, 2019

Last Updated

February 21, 2020

Record last verified: 2020-02

Data Sharing

IPD Sharing
Will not share

Locations

TH(1)