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

To compare effects of psyllium and flaxseed supplement versus those who received a placebo on glycemic and lipids control and constipation in patients with type 2 diabetes (T2D) and chronic constipation.

single-blinded, randomized controlled trial. 90 patients with T2D and chronic constipation will receive either 10 grams of psyllium mixed in biscuit twice per day or 10 grams of flaxseed mixed in biscuit twice per day or placebo biscuit for 12 weeks. Fasting plasma glucose, glycosylated hemoglobin (HbA1c), and lipid profile, as well as the constipation score, will be determined at the beginning and end of 4, 8, and 12-week period. constipation will be a score on the ROME III rating scale .

This is a single-blinded, randomized placebo-control trial of 90 consecutive patients with T2D and symptoms of chronic constipation attending outpatient clinics in Isfahan Endocrine and Metabolism Research Center .

Patients will be included if they had a bowel movement frequency of < 3/week during the past three months; age ≥30 years and diabetes duration > 1 year. Patients will be excluded from the study if they had type 1 diabetes, weight loss, lipid-lowering drug treatment, fiber supplementation, anorectal problems, abdominal pain, and history of opioid use in the last 48 h, any other factors which would interfere with constipation assessment and management, or 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.

Participants in the control group will be received psyllium and sugar-free orange-flavored maltodextrin cookies for 12 weeks as placebo. The psyllium group will be received 10 g psyllium premixed in a sugar-free orange-flavored maltodextrin cookies twice per day for 12 weeks. The flaxseed group will be received 10 g flaxseed premixed in a sugar-free orange-flavored maltodextrin cookies twice per day for 12 weeks.

Primary outcome measures will be included analysis of numerical values of constipation intensity. Secondary outcome measures will be included analysis of the body weight, glycemic and lipid control.

Isfahan Endocrine and Metabolism Research Center

Patients were randomized according to a preexisting list produced by a computer program that differed from a random number generator only in that it assigned equal numbers of patients to each treatment group, and the group assignments were concealed in an opaque sealed envelope.

The trial is single-blinded in that patients will be blind to the treatment. Masking of the two treatments was preserved by creating cookies that looked, tasted, and textured identically. The differences in taste were minimal because the prominent flavor was that of the orange-flavor in which cookies was mixed. Because each participant received only one kind of cookie, the participant had no way to compare their cookie with the other.

Publish paper

starting in March 2018

both people in academic and business

undecided yet

ّFrom M. Janghorbani janghorbani@yahoo.com

Contact with the corresponding person.