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Effects of Almond Versus Pistachio on Weight Loss

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ClinicalTrials.gov Identifier: NCT03120455
Recruitment Status : Completed
First Posted : April 19, 2017
Last Update Posted : March 29, 2018
Sponsor:
Collaborators:
University of Nottingham
Tehran University of Medical Sciences
Information provided by (Responsible Party):
Novindiet Clinic

Study Description
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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.

Condition or disease Intervention/treatment Phase
Obesity Overweight Behavioral: Almond Group Behavioral: Pistachio Group Behavioral: Nut free group Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
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
Actual Study Start Date : June 5, 2017
Actual Primary Completion Date : November 13, 2017
Actual Study Completion Date : January 15, 2018

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Arms and Interventions
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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 Name: 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 Name: 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 Name: NFG


Outcome Measures
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Primary Outcome Measures :
  1. Weight [ Time Frame: 12 Weeks ]
    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 :
  1. Waist circumference [ Time Frame: 12 Weeks ]
    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.

  2. fasting blood glucose [ Time Frame: 12 Weeks ]
    Fasting plasma glucose (FPG) were measured using the enzymatic colorimetric method.

  3. HbA1c [ Time Frame: 12 Weeks ]
    Glycated hamoglobin (HbA1c) was measured by a colorimetric method after an initial separation by ion exchange chromatography (Biosystem, Barcelona, Spain).

  4. HOMA-IR [ Time Frame: 12 Weeks ]
    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

  5. lipid profiles [ Time Frame: 12 Weeks ]

    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)


  6. liver function tests [ Time Frame: 12 Weeks ]
    AST ALT

  7. Insulin [ Time Frame: 12 Weeks ]
    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).


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03120455


Locations
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Iran, Islamic Republic of
NovinDiet Clinic
Tehran, Iran, Islamic Republic of
Sponsors and Collaborators
Novindiet Clinic
University of Nottingham
Tehran University of Medical Sciences
Investigators
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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
More Information
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Responsible Party: Novindiet Clinic
ClinicalTrials.gov Identifier: NCT03120455    
Other Study ID Numbers: ND-204
First Posted: April 19, 2017    Key Record Dates
Last Update Posted: March 29, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Novindiet Clinic:
weight loss
Almond
Pistachio
hypoenergetic diet
Nut
Additional relevant MeSH terms:
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Overweight
Weight Loss
Body Weight
Body Weight Changes