Effects of Almond Versus Pistachio on Weight Loss

Study Overview
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Brief Summary
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The purpose of the current study is comparing the effect of almond and pistachio, as the two common types of nuts, consumption on healthy obese and overweight female who following a hypocaloric diet for 12 weeks. The secondary aim of the current study is to evaluate of these two type of nuts on other cardiometabolic risk factors.

Official Title
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Effects of Almond Versus Pistachio on Weight Loss of Obese and Overweight Female Adults During Hypoenergetic Diet - a Randomized, 12 Week Clinical Trial

Conditions
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Obesity, Overweight

Intervention / Treatment
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* Behavioral: Almond Group
* Behavioral: Pistachio Group
* Behavioral: Nut free group


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Must be female Must be 18-45 years of age. Must have Body mass index (BMI) between 27-35 kg/ m². Must be able to have moderate exercise. Must be interested to have weight loss. Exclusion Criteria: Have allergy to nuts Participating in a research project involving weight loss or physical activity in the previous six months. Pregnancy or lactation during the previous 6 months, or planned pregnancy in the next six months. Taking medication that could affect metabolism or change body weight. Report heart problems, chest pain, and cancer within the last five years. Smoking Menopause Diagnosis of any chronic disease such as fatty liver, cancer, chemo/radio therapy, heart disease, immune compromised conditions, abnormal thyroid hormone level.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Almond group (AG)<br>Obese or overweight female adults will be randomly allocated to have have almond as afternoon snack while they have a hypoenergetic diet. | Behavioral: Almond Group<br>* Obese or overweight female adults will be randomly allocated to have almond as afternoon snacks, while they have a hypoenergetic diet.<br>* Other names: AG;|
| Active Comparator: Pistachio group (PG)<br>Obese or overweight female adults will be randomly allocated to have have Pistachio as afternoon snack while they have a hypoenergetic diet. | Behavioral: Pistachio Group<br>* Obese or overweight female adults will be randomly allocated to have Pistachio as afternoon snacks, while they have a hypoenergetic diet.<br>* Other names: PG;|
| Placebo Comparator: Nut Free (NFG, CG)<br>Obese or overweight female adults are asked to avoid all nuts, seeds, and nut products while they have a hypoenergetic diet. , as the control group. | Behavioral: Nut free group<br>* Obese or overweight female adults will be asked to avoid nuts, seeds and nut products, while they have a hypoenergetic diet.<br>* Other names: NFG;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Weight | Body weight was taken to the nearest 0.1 kg using a digital calibrated scale (Omron Health Care, Hoofddorp, Netherland), whilst subjects wore light clothing and no shoes. | 12 Weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Waist circumference | Waist circumference (WC) was measured with a rigid measuring tape and recorded to the nearest 0.5 cm. WC was measured at the smallest horizontal circumference between the ribs and iliac crest (the natural waist), or, in case of an indeterminable waist narrowing, halfway between the lower rib and the iliac crest. | 12 Weeks | 
| fasting blood glucose | Fasting plasma glucose (FPG) were measured using the enzymatic colorimetric method. | 12 Weeks | 
| HbA1c | Glycated hamoglobin (HbA1c) was measured by a colorimetric method after an initial separation by ion exchange chromatography (Biosystem, Barcelona, Spain). | 12 Weeks | 
| HOMA-IR | Insulin resistance was evaluated by homeostasis model assessment of insulin resistance (HOMA-IR), which was calculated by using the following formula HOMA-IR = [fasting insulin (mU/l) × FPG (mmol/l)]/22.5 | 12 Weeks | 
| lipid profiles | Biochemical analysis of the serum total cholesterol (TC), triglyceride (TG), and high-density lipoprotein (HDL) cholesterol was carried out on a Selectra E auto analyzer (Vita Laboratory, Netherlands) following standard procedures of the Pars Azmoon diagnostic kits (Iran). The LDL cholesterol was calculated using the Friedewald formula. LDL cholesterol = TC - HDL cholesterol + (TG ÷ 2.2) | 12 Weeks | 
| liver function tests | AST ALT | 12 Weeks | 
| Insulin | Insulin was measured by using a radioimmunoassay with 125I-labeled human insulin and a human insulin antiserum in an immunoradiometric assay (IRMA) (Biosource, Dorest, Belgium) with a gamma-counter system (Gamma I; Genesys). | 12 Weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Nut, weight loss, Almond, Pistachio, hypoenergetic diet