Effects of Almond Versus Pistachio on Weight Loss

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

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.

Study Overview

• Status: Completed
• Conditions: Obesity; Overweight
• Intervention / Treatment: Behavioral: Almond Group; Behavioral: Pistachio Group; Behavioral: Nut free group

• Study Type: Interventional
• Enrollment (Actual): 120
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Iran, Islamic Republic of
  • Tehran, Iran, Islamic Republic of
    • NovinDiet Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Almond group (AG); 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; Obese or overweight female adults will be randomly allocated to have almond as afternoon snacks, while they have a hypoenergetic diet.; Other Names: AG
Active Comparator: Pistachio group (PG); 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; Obese or overweight female adults will be randomly allocated to have Pistachio as afternoon snacks, while they have a hypoenergetic diet.; Other Names: PG
Placebo Comparator: Nut Free (NFG, CG); 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; Obese or overweight female adults will be asked to avoid nuts, seeds and nut products, while they have a hypoenergetic diet.; Other Names: NFG

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Novindiet Clinic
• Collaborators: Tehran University of Medical Sciences; University of Nottingham
• Investigators: Study Chair: Hamid R Farshchi, MD, PhD, NovinDiet Clinic, School of Life Sciences, The University of Nottingham; Principal Investigator: Ameneh Madjd, Dr, NovinDiet Clinic, School of Life Sciences, The University of Nottingham

Study record dates

Study Major Dates

• Study Start (Actual): June 5, 2017
• Primary Completion (Actual): November 13, 2017
• Study Completion (Actual): January 15, 2018

Study Registration Dates

• First Submitted: April 15, 2017
• First Submitted That Met QC Criteria: April 15, 2017
• First Posted (Actual): April 19, 2017

Study Record Updates

• Last Update Posted (Actual): March 29, 2018
• Last Update Submitted That Met QC Criteria: March 28, 2018
• Last Verified: March 1, 2018

More Information

Terms related to this study

• Keywords: weight loss; Almond; Pistachio; hypoenergetic diet; Nut
• Additional Relevant MeSH Terms: Body Weight; Body Weight Changes; Weight Loss; Overweight
• Other Study ID Numbers: ND-204

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No