The Effect of Supplementation of Flaxseed, Hesperidin, Flaxseed and Hesperidin Together in Metabolic Syndrome

National Nutrition and Food Technology Institute

Status: Unknown

Conditions: Metabolic Syndrome

Treatments: Other: control; Dietary Supplement: hesperidin; Dietary Supplement: hesperidin and flaxseed; Dietary Supplement: flaxseed

Study type: Interventional

Funder types: Other

Identifiers

NCT03734835

13678

Details and patient eligibility

About

To study the effects of Hesperidin, flaxseed and both together in patients with metabolic syndrome, 100 patients will be randomly allocated to one of following four groups: control group, hesperidin group (2 capsules Hesperidin), flaxseed group (30 gram flaxseed) or flaxseed-hesperidin group (2 capsules Hesperidin and 30 gram flaxseed) for 12 weeks; both groups will be advised to adherence the investigators' diet and exercise program too. At the first and the end of the intervention, metabolic factors will be assessed and compared between groups.

Enrollment: 100 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age of 18 to 70 years
• having 3 of 5 of high blood sugar, hypertension, high TG, high waist circumference, low HD

Exclusion criteria

• pregnancy or lactation
• history of Cardiovascular disease, Pulmonary disease, Renal disease & Celiac disease; Cirrhosis
• Following a program to lose weight in recent 3 mo

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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100 participants in 4 patient groups, including a placebo group

hesperidin and flaxseed

Active Comparator group

Description:

1000 mg hesperidin as two capsules and 30 grams flaxseed

Treatment:

Dietary Supplement: hesperidin and flaxseed

control

Placebo Comparator group

Description:

no supplementation

Treatment:

Other: control

flaxseed

Active Comparator group

Description:

30 grams flaxseed

Treatment:

Dietary Supplement: flaxseed

hesperidin

Active Comparator group

Description:

1000 mg hesperidin as two capsules

Treatment:

Dietary Supplement: hesperidin