NCT02204384

Brief Summary

To compare the acute effect of soluble fiber intake from foods or supplement after a common meal on postprandial plasma glucose and insulin in patients with type 2 diabetes. The hypothesis is a meal with a high content of soluble fiber from food determines glycemic and insulinemic response similar to a meal with a high content of soluble fiber from supplement sources.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
19

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2014

Typical duration for not_applicable

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

July 28, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 30, 2014

Completed
2 days until next milestone

Study Start

First participant enrolled

August 1, 2014

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2016

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2017

Completed
Last Updated

February 14, 2017

Status Verified

February 1, 2017

Enrollment Period

1.6 years

First QC Date

July 28, 2014

Last Update Submit

February 13, 2017

Conditions

Dietary ModificationDiabetes Mellitus Type 2Insulin ToleranceDiabetic Blood Glucose Monitoring

Keywords

Dietary fiberDietary SupplementsType 2 diabetesPostprandial PeriodPlasma insulinPlasma glucoseArea Under CurveSoluble fiber

Outcome Measures

Primary Outcomes (1)

  • Area Under the Curve (AUC 0-180min) for glycemic and insulinemic responses

    Prior to the initial meal A, B and C and 30, 60,120,180 minutes postmeal

Study Arms (3)

HFD Meal: high fiber from food

EXPERIMENTAL

HFD Meal: high amount of fiber from diet food sources (total fiber 9.7g; soluble fiber 5.4g)

Other: HFD Meal: High fiber from food

HFS Meal: High fiber from supplement

EXPERIMENTAL

HFS Meal: high amount of soluble fiber from guar gum supplement (HFS; total fiber 9.1g; soluble fiber 5.4g) - Fiber Mais, Nestlé

Dietary Supplement: HFS Meal: High fiber from supplement

UF Meal: usual amount of fiber

EXPERIMENTAL

UF Meal: usual amount of fiber (total fiber 2.4g; soluble fiber 0.8g)

Other: UF Meal: usual amount of fiber

Interventions

HFD Meal: High fiber from foodOTHER

High amount of fiber from diet food sources (HFD; total fiber 9.7g; soluble fiber 5.4g)

Also known as: HFD
HFD Meal: high fiber from food
HFS Meal: High fiber from supplementDIETARY_SUPPLEMENT

High amount of soluble fiber from guar gum supplement (HFS; total fiber 9.1g; soluble fiber 5.4g) - sachet 5 g Fiber Mais, Nestlé Brasil, São Paulo, BR

Also known as: HFS
HFS Meal: High fiber from supplement
UF Meal: usual amount of fiberOTHER

Usual amount of fiber (UF; total fiber 2.4g; soluble fiber 0.8g)

UF Meal: usual amount of fiber

Eligibility Criteria

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

You may qualify if:

  • Patients with type 2 diabetes
  • Body Mass Index (BMI) \<= 35 kg / m²
  • Hemoglobin A1c (HbA1c) \<= 9%

You may not qualify if:

  • Serum creatinine \>2.0 mg/dL
  • Digestive diseases (e.g. malabsorption)
  • Severe autonomic neuropathy (presence of symptomatic postural hypotension, gastroparesis, diabetic diarrhea)
  • Recent cardiovascular event
  • Cachexia
  • Psychiatric disorder with impairment of understanding
  • Participating in other research protocol

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital de Clínicas de Porto Alegre

Porto Alegre, Rio Grande do Sul, 90035-903, Brazil

Location

Related Publications (1)

  • de Carvalho CM, de Paula TP, Viana LV, Machado VM, de Almeida JC, Azevedo MJ. Plasma glucose and insulin responses after consumption of breakfasts with different sources of soluble fiber in type 2 diabetes patients: a randomized crossover clinical trial. Am J Clin Nutr. 2017 Nov;106(5):1238-1245. doi: 10.3945/ajcn.117.157263. Epub 2017 Aug 30.

    PMID: 28855225DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Mirela J Azevedo, PhD

    Hospital de Clínicas de Porto Alegre

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD

Study Record Dates

First Submitted

July 28, 2014

First Posted

July 30, 2014

Study Start

August 1, 2014

Primary Completion

March 1, 2016

Study Completion

January 1, 2017

Last Updated

February 14, 2017

Record last verified: 2017-02

Locations

BR(1)