NCT03741660

Brief Summary

To examine whether Konjac-mannan fiber improves metabolic control measured by glycemia, lipidemia, and blood pressure in individuals with type-2 diabetes.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
11

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Jan 1991

Longer than P75 for phase_2

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

January 1, 1991

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 1992

Completed
6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 1998

Completed
20.4 years until next milestone

First Submitted

Initial submission to the registry

November 7, 2018

Completed
8 days until next milestone

First Posted

Study publicly available on registry

November 15, 2018

Completed
Last Updated

November 15, 2018

Status Verified

November 1, 2018

Enrollment Period

1.4 years

First QC Date

November 7, 2018

Last Update Submit

November 13, 2018

Conditions

Type2 DiabetesCoronary Heart Disease

Keywords

konjactype2 diabetesfibercoronary heart disease

Outcome Measures

Primary Outcomes (3)

  • change in total:HDL cholesterol

    change from baseline at week 3, relative to control

  • change in fructosamine

    change from baseline at week 3, relative to control

  • change in systolic blood pressure

    change from baseline at week 3, relative to control

Secondary Outcomes (10)

  • change in total cholesterol

    change from baseline at week 3, relative to control

  • change in LDL cholesterol

    change from baseline at week 3, relative to control

  • change in HDL cholesterol

    change from baseline at week 3, relative to control

  • change in apolipoprotein A-1

    change from baseline at week 3, relative to control

  • change in apolipoprotain B

    change from baseline at week 3, relative to control

  • +5 more secondary outcomes

Study Arms (2)

Konjac-mannan

EXPERIMENTAL

Konjac-mannan fiber-enriched biscuits with NCEP Step II metabolically controlled diet

Dietary Supplement: konjac glucomannan

Placebo

PLACEBO COMPARATOR

wheat bran fiber biscuits with NCEP Step II metabolically controlled diet

Dietary Supplement: wheat bran

Interventions

konjac glucomannanDIETARY_SUPPLEMENT

Konjac-mannan fiber-enriched biscuits (0.7 g/412KJ \[100kcal\] of glucommanan)

Konjac-mannan
wheat branDIETARY_SUPPLEMENT

Wheat bran (hard red wheat bran) fiber enriched biscuits

Placebo

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • hyperlipidemia controlled by medication
  • hypertension controlled by medication
  • type 2 diabetes controlled by medication
  • minimum 3 years since onset of all three conditions
  • sedentary lifestyle

You may not qualify if:

  • regular smoking
  • regular alcohol consumption
  • family history of premature coronary heart disease
  • hypothyroidism
  • renal, hepatic or gastrointestinal disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Coronary Disease

Interventions

(1-6)-alpha-glucomannanDietary Fiber

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular Diseases

Intervention Hierarchy (Ancestors)

Dietary CarbohydratesCarbohydratesFoodDiet, Food, and NutritionPhysiological PhenomenaFood and Beverages

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 7, 2018

First Posted

November 15, 2018

Study Start

January 1, 1991

Primary Completion

June 1, 1992

Study Completion

June 1, 1998

Last Updated

November 15, 2018

Record last verified: 2018-11