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

Effect of Psyllium and Flaxseed on glucose, lipids, and constipation in patients with type 2 diabetes and chronic constipation

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20110416006202N2
Enrollment
90
Registered
2017-12-29
Start date
2017-09-23
Completion date
Unknown
Last updated
2018-02-22

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

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]

Interventions

Intervention 1: Intervention 2: 10 grams of psyllium mixed in cookies twice per day for 12 weeks. Kamvar Co., Isfahan, Iran. Intervention 2: Intervention 1:10 grams of faxseed mixed in cookies twice p
Treatment - Drugs
Placebo
Intervention 2: 10 grams of psyllium mixed in cookies twice per day for 12 weeks. Kamvar Co., Isfahan, Iran
Intervention 1:10 grams of faxseed mixed in cookies twice per day for 12 weeks. Kamvar Co., Isfahan, Iran
Control group: Participants in the control group will be received psyllium, falxseed and sugar-free orange-flavored maltodextrin cookies for 12 weeks as placebo. Kamvar Co., Isfahan, Iran

Sponsors

Esfahan University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
30 Years to 75 Years

Inclusion criteria

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

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.

Design outcomes

Primary

MeasureTime frame
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.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactNoreddin Soltanian

Isfahan Endocrin and Metabolism Research Center

noreddinsol121@gmail.com+98 913 313 2180

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Mar 6, 2026