The effect of bitter almond gum supplement on type 2 diabetes

The effect of bitter almond gum supplement on the metabolic, inflammatory, and mental health indicators in women with type 2 diabetes

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT20150205020965N7

Enrollment

Registered

2020-12-23

Start date

2020-11-21

Completion date

Unknown

Last updated

2021-01-05

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

Conditions

Type 2 diabetes. Type 2 diabetes mellitus

Interventions

Intervention 1: Intervention group: Bitter almond gum. This group will dissolve and consume two sachets (2* 5 gr) of Bitter almond gum ( Payar Tejarat Zomorodin Company, Iran) twice a day, in the morn

Eligibility

Sex/Gender

Female

Age

30 Years to 50 Years

Inclusion criteria

Inclusion criteria: Having type 2 diabetes for more than six months according to International Diabetes Federation (fasting blood sugar level more than 126 mg/dl) Age: 30-50 y Using anti-diabetic drugs and maintaining them in the period of the study Having a normal diet Body Mass Index (BMI) more than 25 kg/m2 in the last 3 months

Exclusion criteria

Exclusion criteria: Having a history of gastrointestinal Having history cardiovascular Having a history of renal Having a history of thyroid Having a history of liver; or pancreatic diseases Pregnancy and lactating Smokers Consuming prebiotic and probiotics’ products

Design outcomes

Primary

Measure	Time frame
Hemoglobin A1C (HbA1c). Timepoint: At baseline and two months after baseline. Method of measurement: Autoanalyzer.;Lipid profile (TG, TC, HDL-c). Timepoint: At baseline and two months after baseline. Method of measurement: Autoanalyzer.;Tryptophan. Timepoint: At baseline and two months after baseline. Method of measurement: Eliza kit.;Kynurenine. Timepoint: At baseline and two months after baseline. Method of measurement: Eliza kit.;Fasting glucose. Timepoint: At baseline and two months after baseline. Method of measurement: Colorimetric Assay Kit.;Cortisol. Timepoint: At baseline and two months after baseline. Method of measurement: Eliza Kit.;Glucagon-like peptide1. Timepoint: At baseline and two months after baseline. Method of measurement: Eliza kit.;Fasting insulin. Timepoint: At baseline and two months after baseline. Method of measurement: Eliza kit.;Carboxymethyl lysine. Timepoint: At baseline and two months after baseline. Method of measurement: Eliza kit.;S-RAGE (soluble receptor for AGE). Timepoint: At baseline and two months after baseline. Method of measurement: Eliza kit.;Nitric oxide. Timepoint: At baseline and two months after baseline. Method of measurement: Eliza kit.;Interleukin 6. Timepoint: At baseline and two months after baseline. Method of measurement: Eliza kit.;Highly sensitive C-reactive protein(hs-CRP ). Timepoint: At baseline and two months after baseline. Method of measurement: Eliza kit.;Tumor Necrosis Factor (TNF). Timepoint: At baseline and two months after baseline. Method of measurement: Eliza kit.;Interleukin 10 (IL10 ). Timepoint: At baseline and two months after baseline. Method of measurement: Eliza kit.;Total antioxidant capacity. Timepoint: At baseline and two months after baseline. Method of measurement: Total Antioxidant Capacity (TAC) Assay Kit.;Malondialdehyde. Timepoint: At baseline and two months after baseline. Method of measurement: Colorimetric Assay Kit.;8-iso-prostaglandin F2a (8-iso-PGF2a). Timepoint: At baseline	—

Measure

Time frame

Hemoglobin A1C (HbA1c). Timepoint: At baseline and two months after baseline. Method of measurement: Autoanalyzer.;Lipid profile (TG, TC, HDL-c). Timepoint: At baseline and two months after baseline. Method of measurement: Autoanalyzer.;Tryptophan. Timepoint: At baseline and two months after baseline. Method of measurement: Eliza kit.;Kynurenine. Timepoint: At baseline and two months after baseline. Method of measurement: Eliza kit.;Fasting glucose. Timepoint: At baseline and two months after baseline. Method of measurement: Colorimetric Assay Kit.;Cortisol. Timepoint: At baseline and two months after baseline. Method of measurement: Eliza Kit.;Glucagon-like peptide1. Timepoint: At baseline and two months after baseline. Method of measurement: Eliza kit.;Fasting insulin. Timepoint: At baseline and two months after baseline. Method of measurement: Eliza kit.;Carboxymethyl lysine. Timepoint: At baseline and two months after baseline. Method of measurement: Eliza kit.;S-RAGE (soluble receptor for AGE). Timepoint: At baseline and two months after baseline. Method of measurement: Eliza kit.;Nitric oxide. Timepoint: At baseline and two months after baseline. Method of measurement: Eliza kit.;Interleukin 6. Timepoint: At baseline and two months after baseline. Method of measurement: Eliza kit.;Highly sensitive C-reactive protein(hs-CRP ). Timepoint: At baseline and two months after baseline. Method of measurement: Eliza kit.;Tumor Necrosis Factor (TNF). Timepoint: At baseline and two months after baseline. Method of measurement: Eliza kit.;Interleukin 10 (IL10 ). Timepoint: At baseline and two months after baseline. Method of measurement: Eliza kit.;Total antioxidant capacity. Timepoint: At baseline and two months after baseline. Method of measurement: Total Antioxidant Capacity (TAC) Assay Kit.;Malondialdehyde. Timepoint: At baseline and two months after baseline. Method of measurement: Colorimetric Assay Kit.;8-iso-prostaglandin F2a (8-iso-PGF2a). Timepoint: At baseline

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Secondary

Measure	Time frame
Body Mass Index (BMI). Timepoint: At baseline and two months after baseline. Method of measurement: Scale-Meter.;Daily macronutrient intake (Energy, carbohydrate, protein, fat). Timepoint: At baseline and two months after baseline. Method of measurement: Questionnaire (24-hour Dietary Recall).;Waist circumference (WHR). Timepoint: At baseline and two months after baseline. Method of measurement: Calculation.;Blood pressure. Timepoint: At baseline and two months after baseline. Method of measurement: Mercuric barometr.;Assessment of the body composition. Timepoint: At baseline and two months after baseline. Method of measurement: Bioelectrical impedance analysis.;Mental health. Timepoint: At baseline and two months after baseline. Method of measurement: Questionnaire (Depression Anxiety Stress Questionnaire, General Health Questionnaire ).;Appetite status. Timepoint: At baseline and two months after baseline. Method of measurement: Visual Analogue Scale Questionnaire.	—

Measure

Time frame

Body Mass Index (BMI). Timepoint: At baseline and two months after baseline. Method of measurement: Scale-Meter.;Daily macronutrient intake (Energy, carbohydrate, protein, fat). Timepoint: At baseline and two months after baseline. Method of measurement: Questionnaire (24-hour Dietary Recall).;Waist circumference (WHR). Timepoint: At baseline and two months after baseline. Method of measurement: Calculation.;Blood pressure. Timepoint: At baseline and two months after baseline. Method of measurement: Mercuric barometr.;Assessment of the body composition. Timepoint: At baseline and two months after baseline. Method of measurement: Bioelectrical impedance analysis.;Mental health. Timepoint: At baseline and two months after baseline. Method of measurement: Questionnaire (Depression Anxiety Stress Questionnaire, General Health Questionnaire ).;Appetite status. Timepoint: At baseline and two months after baseline. Method of measurement: Visual Analogue Scale Questionnaire.

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Countries

Iran (Islamic Republic of)

Contacts

Public ContactParvin Dehghan

Tabriz University of Medical Sciences

dehghan.nut@gmail.com+98 33340634

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 12, 2026