Effect of Psyllium and Flaxseed on glucose, lipids, and constipatio

Phase 2

Conditions: Condition 1: Constipation. Condition 2: Cholesterol and lipid metabolism. Condition 3: ?Elevated blood glucose. Condition 4: BMI.
Constipation
Disorders of bile acid and cholesterol metabolism
Elevated blood glucose level
Body mass index [BMI]

Registration Number: IRCT20110416006202N2

Lead Sponsor: Esfahan University of Medical Sciences

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Complete

Sex: All

Target Recruitment: 90

Inclusion Criteria

Patients were included if they had type 2 diabetes.
A bowel movement frequency of < 3/week during the past three months.

Exclusion Criteria

Patients were excluded from the study if they had weight loss,
rectal bleeding
abdominal pain
history of opioid use in the last 48 h
pre-existing severe cardiac
endocrinological
hematological
hepatic
renal
metabolic
neurological or psychiatric disorders
Pregnant or nursing women will be excluded
Non-compliant patients during baseline or treatment phases as evaluated by taking <75% of either of the test articles during a one-week period throughout the course of the study will be excluded from the evaluable patient data analysis.

Study & Design

Study Type: interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Constipation intensity. Timepoint: Beginning, 4, 8, 12 week after intervention. Method of measurement: ROME III.;Body weight. Timepoint: Beginning, 4, 8, 12 week after intervention. Method of measurement: Body mass index and body weight.;Lipids . Timepoint: Beginning, 4, 8, 12 week after intervention. Method of measurement: Routine measurement of total cholesterol, triglyceride, low-density lipoprotein cholesterol, high-density lipoprotein cholesterol,.;Fasting plasma glucose . Timepoint: Beginning, 4, 8, 12 week after intervention. Method of measurement: Oxidase method.

Secondary Outcome Measures