Prebiotic effect in patients with type 2 diabetes.

Clinical trial of prebiotics effect on the level of perceived stress, cortisol, interferon gamma, and appetite in patients with type 2 diabetes.

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

IRCT

Registry ID

IRCT2016122720965N2

Enrollment

Registered

2017-04-02

Start date

2018-03-12

Completion date

Unknown

Last updated

2019-01-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Type 2 Diabetes. Diabetes mellitus due to underlying condition

Interventions

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).

Eligibility

Sex/Gender

Female

Age

30 Years to 50 Years

Inclusion 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

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.

Design outcomes

Primary

Measure	Time frame
Cortisol. 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.;Perceived stress. Timepoint: Before start intervention and 8 weeks after intervention. Method of measurement: Perceived stress questionnaire.;IL18. 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.;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.;Insulin. Timepoint: Before start intervention and 8 weeks after intervention. Method of measurement: kit.;TNF. 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.;FBS. Timepoint: Before start intervention and 8 weeks after intervention. Method of measurement: KIT.	—

Measure

Time frame

Cortisol. 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.;Perceived stress. Timepoint: Before start intervention and 8 weeks after intervention. Method of measurement: Perceived stress questionnaire.;IL18. 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.;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.;Insulin. Timepoint: Before start intervention and 8 weeks after intervention. Method of measurement: kit.;TNF. 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.;FBS. Timepoint: Before start intervention and 8 weeks after intervention. Method of measurement: KIT.

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Secondary

Measure	Time frame
Appetite. Timepoint: Before start intervention and 8 weeks after intervention. Method of measurement: Questionnaire.;GHrelin. Timepoint: Before start intervention and 8 weeks after intervention. Method of measurement: kite.;Quality of life. Timepoint: Before start intervention and 8 weeks after intervention. Method of measurement: Questionnaire.;Tryptophan. Timepoint: Before start intervention and 8 weeks after intervention. Method of measurement: kit.;Kynurenine. 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.;Alkaline phosphatase (ALP). 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.;Aspartate aminotransferase (AST). 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.;Malondialdehyde. Timepoint: Before start intervention and 8 weeks after intervention. Method of measurement: kit.;Soluble receptor for advanced glycation end-products. 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.;Triglyceride. 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.;HDL. 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: k	—

Measure

Time frame

Appetite. Timepoint: Before start intervention and 8 weeks after intervention. Method of measurement: Questionnaire.;GHrelin. Timepoint: Before start intervention and 8 weeks after intervention. Method of measurement: kite.;Quality of life. Timepoint: Before start intervention and 8 weeks after intervention. Method of measurement: Questionnaire.;Tryptophan. Timepoint: Before start intervention and 8 weeks after intervention. Method of measurement: kit.;Kynurenine. 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.;Alkaline phosphatase (ALP). 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.;Aspartate aminotransferase (AST). 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.;Malondialdehyde. Timepoint: Before start intervention and 8 weeks after intervention. Method of measurement: kit.;Soluble receptor for advanced glycation end-products. 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.;Triglyceride. 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.;HDL. 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: k

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Countries

Iran (Islamic Republic of)

Contacts

Public ContactDehghan

Tabriz university of medical sience

DEHGHAN.NUT@GMAIL.COM+98 41 3335 7581

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026