NCT03805802

Brief Summary

This study evaluates the effects of an ad libitum addition of a high fiber product to the regular diet of type 2 diabetes patients on body weight and blood sugar control. In the first 6 weeks half of the participants will receive the high fiber test product and half a reference product without fiber. After the first 6 weeks both groups will be switched to the high fiber product.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
34

participants targeted

Target at below P25 for not_applicable diabetes-mellitus-type-2

Timeline
Completed

Started Feb 2019

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

First Submitted

Initial submission to the registry

January 13, 2019

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 16, 2019

Completed
19 days until next milestone

Study Start

First participant enrolled

February 4, 2019

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2020

Completed
Last Updated

October 22, 2020

Status Verified

October 1, 2020

Enrollment Period

1.2 years

First QC Date

January 13, 2019

Last Update Submit

October 20, 2020

Conditions

Diabetes Mellitus, Type 2ObesityOverweightMetabolic Syndrome

Keywords

fibertype 2 diabetesdietary interventionweight lossglucose controlobesityoverweightmetabolic syndromeoats

Outcome Measures

Primary Outcomes (1)

  • Fasting glucose

    Change in the concentratino of fasting venous glucose of daily LOB consumption in mg/dl as compared to the change in fasting glucose for the placebo group at 6 weeks.

    6 weeks

Secondary Outcomes (27)

  • Fasting glucose

    12 weeks

  • HBA1c

    6 weeks

  • HBA1c

    12 weeks

  • Self-documented glucose

    6 weeks

  • Self-documented glucose

    12 weeks

  • +22 more secondary outcomes

Other Outcomes (6)

  • Systolic lood pressure

    6 weeks

  • Diastolic blood pressure

    6 weeks

  • Systolic blood pressure

    12 weeks

  • +3 more other outcomes

Study Arms (2)

active product

EXPERIMENTAL

Once daily ad libitum consumption of one package of the fiber product 6 weeks (blinded phase). Once daily ad libitum consumption of one package of the fiber product 6 weeks (open phase).

Other: active product

reference product

PLACEBO COMPARATOR

Once daily ad libitum consumption of one package of placebo during 6 weeks (blinded phase). Once daily ad libitum consumption of one package of the fiber product 6 weeks (open phase).

Other: active productOther: reference product

Interventions

active productOTHER

Once daily consumption over the period of the study

Also known as: LOB, Liquid Oat Bran, High fiber product
active productreference product
reference productOTHER

Once daily consumption over the period of the study

Also known as: placebo food product
reference product

Eligibility Criteria

Age30 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Type 2 Diabetes with inadequate glucose control and a HbA1c \>7,5 and \< 9%
  • Treatment with all oral antidiabetic medication or injectable GLP-1 analogues
  • BMI 28,0-39,9 kg/m²
  • Age 30-70 years

You may not qualify if:

  • insulin treatment
  • Psychiatric Disease
  • Acute Infections
  • Alcohol or drug abuse
  • Acute diverticulitis
  • Malignant tumors or hematologic disorders
  • Heart failure NYHA III-IV
  • Acute coronary syndrome
  • Chronic kidney disease \> Stage 3 (KDOQI)
  • Pregnancy or Lactation
  • Previous bariatric interventions

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Stoffwechselzentrum Rhein-Pfalz

Mannheim, Baden-Wurttemberg, 68163, Germany

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2ObesityOverweightMetabolic SyndromeWeight Loss

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesOvernutritionNutrition DisordersBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsInsulin ResistanceHyperinsulinismBody Weight Changes

Study Officials

  • Per M Humpert, M. D.

    Director of Stoffwechselzentrum Rhein-Pfalz

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
The investigator receives reference product and the test product in boxes labelled "stratus" "nimbus" and "cumulus". first 6 weeks participants are randomly assigned to "stratus" or "nimbus" and the second 6 weeks participants all receive "cumulus".
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: First 6 weeks double blinded vs. a reference product and second 6 weeks open label both groups receive the test product in the second 6 weeks.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director of Stoffwechselzentrum Rhein - Pfalz

Study Record Dates

First Submitted

January 13, 2019

First Posted

January 16, 2019

Study Start

February 4, 2019

Primary Completion

April 1, 2020

Study Completion

April 1, 2020

Last Updated

October 22, 2020

Record last verified: 2020-10

Data Sharing

IPD Sharing
Will not share

Locations

DE(1)