Low Fructose Diet in Diabetes Type 2 | NCT03352596

Studies
Low Fructose Diet in Diabetes Type 2

NCT03352596

Sponsor

National Nutrition and Food Technology Institute

Status

Unknown status

Last Update Posted

Nov 24, 2017Actual

Enrollment

48Actual

Phase

Not Applicable

Conditions

Fructose Metabolism Disorder

Interventions

low frutose diet

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2017

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Active, not recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 1, 2017Actual

Primary Completion Date

Oct 1, 2017Actual

Completion Date

Nov 30, 2017Estimated

First Submitted Date

Nov 13, 2017

First Submission Date that Met QC Criteria

Nov 20, 2017

First Posted Date

Nov 24, 2017Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 20, 2017

Last Update Posted Date

Nov 24, 2017Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Dr Azita Hekmatdoost, Principal Investigator, National Nutrition and Food Technology InstitutePrincipal Investigator

Lead Sponsor

National Nutrition and Food Technology InstituteOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Diabetes is one of the most common and chronic diseases in the world, with the prevalence and incidence of this disease rising in most societies, especially in Iran. Suitable treatments for type 2 diabetes include changing lifestyle with exercise, nutrition, and drug use. New research suggests that added sugar, especially fructose, is the main trigger for diabetes and pre-diabetes even more potent than other carbohydrates. Fructose has a low glycemic index (23μg =) and slowly increases blood glucose levels. Therefore, it is thought that replacing fructose instead of glucose can have a positive effect on glycemic control of diabetic patients..

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

48Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
intervention group	Experimental	Eight weeks of low fructose diet with a maximum of 12 g of fructose	Other: low frutose diet
control group	No Intervention	Eight weeks of regular diabetic diet with a 15%pro 30%fat 55%CHO

Interventions

Name	Type	Description	Arm Group Labels	Other Names
low frutose diet	Other		intervention group

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
fasting blood suger(FBS)		8 weeks
Homeostatic model assessment and insulin resistance(HOMA-IR)		8weeks
insulin		8 weeks

Secondary Outcomes

Measure	Description	Time Frame
Triglyceride		8 weeks
Total cholestrole		8 weeks
LDL-C

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Age of 70-40 years
body mass index(BMI) between 18.5 and 27
Type 2 diabetes People who only control their diabetes by using glucose lowering tablets Type 2 diabetes (1 to 10 years)

Exclusion Criteria:

Pregnancy and lactation
Thyroid gland disorders
Kidney disease and inflammation
Follow the weight loss regimen 6 months before starting the study
Usage of fatty and fatty foods, fiber powder Vitamin A Mineral Supplements, Omega 3
Taking glucocorticoid drugs and non-steroidal anti-inflammatory drugs

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

40 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided