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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.

Register:	IRCT
Last refreshed on:	14 January 2019
Main ID:	IRCT2016122720965N2
Date of registration:	2017-04-02
Prospective Registration:	Yes
Primary sponsor:	Vice chancellor for reserach, Tabriz University of Medical Sciences
Public title:	Prebiotic effect in patients with type 2 diabetes.
Scientific title:	Clinical trial of prebiotics effect on the level of perceived stress, cortisol, interferon gamma, and appetite in patients with type 2 diabetes.
Date of first enrolment:	2018-03-12
Target sample size:	80
Recruitment status:	Complete
URL:	http://en.irct.ir/trial/18504
Study type:	interventional
Study design:	Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: T2DM patients randomly allocated to two groups using a block randomization procedure, after matching of BMI and age, Blinding description: Researcher and patients will not be aware of the type of intervention. The third person will distribute the supplement among patients.
Phase:	2

Countries of recruitment
Iran (Islamic Republic of)

Contacts

Name:	Dehghan
Address:	Tabriz University Of Medical Sciences, Nutrition Faculty, Attar Neyshabori Street, Golghash street. 5166614711 Tabriz Iran (Islamic Republic of)
Telephone:	+98 41 3335 7581
Email:	DEHGHAN.NUT@GMAIL.COM
Affiliation:	Tabriz university of medical sience

Name:	Parvin Dehghan
Address:	Tabriz University Of Medical Sciences, Nutrition Faculty, Attar Neyshabori Street, Golghash street. 5166614711 Tabriz Iran (Islamic Republic of)
Telephone:	+98 41 3335 7581
Email:	dehghan.nut@gmail.com
Affiliation:	Tabriz University Of Medical Sciences

Key inclusion & exclusion criteria

Inclusion criteria: Having type 2 diabetes for more than six months according International Diabetes Federation (fasting blood sugar level more than 126 mg/dl)
Using anti-diabetic drugs and maintaining them in the period of the study
Having a normal diet and Body Mass Index (BMI) more than 25 kg/m2 in the last 3 months
Exclusion criteria: Having history of gastrointestinal; cardiovascular; renal; thyroid; liver; or pancreatic diseases
Pregnancy and lactating
Smokers
Consuming prebiotic and probiotics’ products
Consuming antibiotics; antiacids; alcohol; anti-diarrheal; anti-inflammatory; lipid-lowering; laxatives or insulin
Having a typical fiber intake more than 30g/d.

Age minimum: 30 years
Age maximum: 50 years
Gender: Female

Health Condition(s) or Problem(s) studied

Type 2 Diabetes.
Diabetes mellitus due to underlying condition

Intervention(s)

Intervention 1: Intervention group 1 : prebiotic (Nutriose,10g/d, for 8 weeks). Intervention 2: Intervention group 2 (placebo): Matodextrin (matodextrin ,10g/d, for 8 weeks).

Primary Outcome(s)

Cortisol. Timepoint: Before start intervention and 8 weeks after intervention. Method of measurement: Kit.

IL6. Timepoint: Before start intervention and 8 weeks after intervention. Method of measurement: KIT.

Leptin. Timepoint: Before start intervention and 8 weeks after intervention. Method of measurement: kit.

IL18. Timepoint: Before start intervention and 8 weeks after intervention. Method of measurement: kit.

Perceived stress. Timepoint: Before start intervention and 8 weeks after intervention. Method of measurement: Perceived stress questionnaire.

TNF. Timepoint: Before start intervention and 8 weeks after intervention. Method of measurement: KIT.

Interfron gamma. Timepoint: Before start intervention and 8 weeks after intervention. Method of measurement: Kit.

Adiponectin. Timepoint: Before start intervention and 8 weeks after intervention. Method of measurement: kit.

IL10. Timepoint: Before start intervention and 8 weeks after intervention. Method of measurement: Kit.

FBS. Timepoint: Before start intervention and 8 weeks after intervention. Method of measurement: KIT.

Insulin. Timepoint: Before start intervention and 8 weeks after intervention. Method of measurement: kit.

Secondary Outcome(s)

GHrelin. Timepoint: Before start intervention and 8 weeks after intervention. Method of measurement: kite.

Kynurenine. Timepoint: Before start intervention and 8 weeks after intervention. Method of measurement: kit.

Malondialdehyde. Timepoint: Before start intervention and 8 weeks after intervention. Method of measurement: kit.

Total antioxidant capacity. Timepoint: Before start intervention and 8 weeks after intervention. Method of measurement: kit.

Appetite. Timepoint: Before start intervention and 8 weeks after intervention. Method of measurement: Questionnaire.

Brain-derived neurotrophic factor. Timepoint: Before start intervention and 8 weeks after intervention. Method of measurement: kit.

Complete Blood Count. Timepoint: Before start intervention and 8 weeks after intervention. Method of measurement: Full Diff device.

Soluble receptor for advanced glycation end-products. Timepoint: Before start intervention and 8 weeks after intervention. Method of measurement: kit.

LDL. Timepoint: Before start intervention and 8 weeks after intervention. Method of measurement: kit.

Quality of life. Timepoint: Before start intervention and 8 weeks after intervention. Method of measurement: Questionnaire.

Superoxide dismutase. Timepoint: Before start intervention and 8 weeks after intervention. Method of measurement: kit.

Alanine aminotransferase (ALT). Timepoint: Before start intervention and 8 weeks after intervention. Method of measurement: Kit.

Alkaline phosphatase (ALP). Timepoint: Before start intervention and 8 weeks after intervention. Method of measurement: kit.

Aspartate aminotransferase (AST). Timepoint: Before start intervention and 8 weeks after intervention. Method of measurement: Kit.

Glutathione peroxidase. Timepoint: Before start intervention and 8 weeks after intervention. Method of measurement: kit.

Uric acid. Timepoint: Before start intervention and 8 weeks after intervention. Method of measurement: kit.

Total cholesterol. Timepoint: Before start intervention and 8 weeks after intervention. Method of measurement: kit.

Catalase. Timepoint: Before start intervention and 8 weeks after intervention. Method of measurement: kit.

Obestatin. Timepoint: Before start intervention and 8 weeks after intervention. Method of measurement: kit.

Triglyceride. Timepoint: Before start intervention and 8 weeks after intervention. Method of measurement: kit.

Pentosidine. Timepoint: Before start intervention and 8 weeks after intervention. Method of measurement: kit.

Food intake. Timepoint: Before start intervention and 8 weeks after intervention. Method of measurement: Questionnaire.

HDL. Timepoint: Before start intervention and 8 weeks after intervention. Method of measurement: kit.

Blood urea nitrogen. Timepoint: Before start intervention and 8 weeks after intervention. Method of measurement: kit.

Carboxymethyl lysine. Timepoint: Before start intervention and 8 weeks after intervention. Method of measurement: kit.

Tryptophan. Timepoint: Before start intervention and 8 weeks after intervention. Method of measurement: kit.

Endotoxin. Timepoint: Before start intervention and 8 weeks after intervention. Method of measurement: kit.

Quality of sleep. Timepoint: Before start intervention and 8 weeks after intervention. Method of measurement: Questionnaire.

Secondary ID(s)

Source(s) of Monetary Support

Vice chancellor for reserach, Tabriz University of Medical Sciences

Secondary Sponsor(s)

Ethics review

Status: Approved
Approval date:
Contact:

Ethics committee of Tabriz University of Medical Sciences

Results

Results available:
Date Posted:
Date Completed:
URL:

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