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Effects of Almond Versus Pistachio on Weight Loss

Primary Purpose

Obesity, Overweight

Status
Completed
Phase
Not Applicable
Locations
Iran, Islamic Republic of
Study Type
Interventional
Intervention
Almond Group
Pistachio Group
Nut free group
Sponsored by
Novindiet Clinic
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Obesity focused on measuring weight loss, Almond, Pistachio, hypoenergetic diet, Nut

Eligibility Criteria

18 Years - 45 Years (Adult)FemaleAccepts Healthy Volunteers

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.

Sites / Locations

  • NovinDiet Clinic

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Placebo Comparator

Arm Label

Almond group (AG)

Pistachio group (PG)

Nut Free (NFG, CG)

Arm Description

Obese or overweight female adults will be randomly allocated to have have almond as afternoon snack while they have a hypoenergetic diet.

Obese or overweight female adults will be randomly allocated to have have Pistachio as afternoon snack while they have a hypoenergetic diet.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
fasting blood glucose
Fasting plasma glucose (FPG) were measured using the enzymatic colorimetric method.
HbA1c
Glycated hamoglobin (HbA1c) was measured by a colorimetric method after an initial separation by ion exchange chromatography (Biosystem, Barcelona, Spain).
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
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)
liver function tests
AST ALT
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).

Full Information

First Posted
April 15, 2017
Last Updated
March 28, 2018
Sponsor
Novindiet Clinic
Collaborators
University of Nottingham, Tehran University of Medical Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT03120455
Brief Title
Effects of Almond Versus Pistachio on Weight Loss
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
Study Type
Interventional

2. Study Status

Record Verification Date
March 2018
Overall Recruitment Status
Completed
Study Start Date
June 5, 2017 (Actual)
Primary Completion Date
November 13, 2017 (Actual)
Study Completion Date
January 15, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novindiet Clinic
Collaborators
University of Nottingham, Tehran University of Medical Sciences

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity, Overweight
Keywords
weight loss, Almond, Pistachio, hypoenergetic diet, Nut

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
120 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Almond group (AG)
Arm Type
Experimental
Arm Description
Obese or overweight female adults will be randomly allocated to have have almond as afternoon snack while they have a hypoenergetic diet.
Arm Title
Pistachio group (PG)
Arm Type
Active Comparator
Arm Description
Obese or overweight female adults will be randomly allocated to have have Pistachio as afternoon snack while they have a hypoenergetic diet.
Arm Title
Nut Free (NFG, CG)
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Almond Group
Other Intervention Name(s)
AG
Intervention Description
Obese or overweight female adults will be randomly allocated to have almond as afternoon snacks, while they have a hypoenergetic diet.
Intervention Type
Behavioral
Intervention Name(s)
Pistachio Group
Other Intervention Name(s)
PG
Intervention Description
Obese or overweight female adults will be randomly allocated to have Pistachio as afternoon snacks, while they have a hypoenergetic diet.
Intervention Type
Behavioral
Intervention Name(s)
Nut free group
Other Intervention Name(s)
NFG
Intervention Description
Obese or overweight female adults will be asked to avoid nuts, seeds and nut products, while they have a hypoenergetic diet.
Primary Outcome Measure Information:
Title
Weight
Description
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.
Time Frame
12 Weeks
Secondary Outcome Measure Information:
Title
Waist circumference
Description
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.
Time Frame
12 Weeks
Title
fasting blood glucose
Description
Fasting plasma glucose (FPG) were measured using the enzymatic colorimetric method.
Time Frame
12 Weeks
Title
HbA1c
Description
Glycated hamoglobin (HbA1c) was measured by a colorimetric method after an initial separation by ion exchange chromatography (Biosystem, Barcelona, Spain).
Time Frame
12 Weeks
Title
HOMA-IR
Description
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
Time Frame
12 Weeks
Title
lipid profiles
Description
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)
Time Frame
12 Weeks
Title
liver function tests
Description
AST ALT
Time Frame
12 Weeks
Title
Insulin
Description
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).
Time Frame
12 Weeks

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hamid R Farshchi, MD, PhD
Organizational Affiliation
NovinDiet Clinic, School of Life Sciences, The University of Nottingham
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Ameneh Madjd, Dr
Organizational Affiliation
NovinDiet Clinic, School of Life Sciences, The University of Nottingham
Official's Role
Principal Investigator
Facility Information:
Facility Name
NovinDiet Clinic
City
Tehran
Country
Iran, Islamic Republic of

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Effects of Almond Versus Pistachio on Weight Loss

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