Effects of Almond Versus Pistachio on Weight Loss

Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03120455
• Other study ID #: ND-204
• Status: Completed
• Phase: N/A
• First received: April 15, 2017
• Last updated: March 28, 2018
• Start date: June 5, 2017
• Est. completion date: January 15, 2018

Study information

• Verified date: March 2018
• Source: Novindiet Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: January 15, 2018
• Est. primary completion date: November 13, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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.

Related Conditions & MeSH terms

• Obesity
• Overweight
• Weight Loss

Intervention

Behavioral:
• Almond Group
Obese or overweight female adults will be randomly allocated to have almond as afternoon snacks, while they have a hypoenergetic diet.
• Pistachio Group
Obese or overweight female adults will be randomly allocated to have Pistachio as afternoon snacks, while they have a hypoenergetic diet.
• Nut free group
Obese or overweight female adults will be asked to avoid nuts, seeds and nut products, while they have a hypoenergetic diet.

Locations

Country	Name	City	State
Iran, Islamic Republic of	NovinDiet Clinic	Tehran

Sponsors (3)

Lead Sponsor	Collaborator
Novindiet Clinic	Tehran University of Medical Sciences, University of Nottingham

Country where clinical trial is conducted

Iran, Islamic Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	fasting blood glucose	Fasting plasma glucose (FPG) were measured using the enzymatic colorimetric method.	12 Weeks
Secondary	HbA1c	Glycated hamoglobin (HbA1c) was measured by a colorimetric method after an initial separation by ion exchange chromatography (Biosystem, Barcelona, Spain).	12 Weeks
Secondary	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
Secondary	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
Secondary	liver function tests	AST ALT	12 Weeks
Secondary	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