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Completed

NCT Number: NCT03120455

Effects of Almond Versus Pistachio on Weight Loss

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.

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Key information

Conditions

Obesity Body Weight Body Weight Changes Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms Weight Loss

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

NovinDiet Clinic

Tehran, Iran

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Almond Group

Behavioral

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

Other names: AG

Pistachio Group

Behavioral

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

Other names: PG

Nut free group

Behavioral

Obese or overweight female adults will be asked to avoid nuts, seeds and nut products, while they have a hypoenergetic diet.

Other names: NFG

Primary outcomes

  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 outcomes

  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).

Sponsors and collaborators

Lead sponsor

Novindiet Clinic

Other

Collaborators

  • Tehran University of Medical Sciences
  • University of Nottingham

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2017
Study completion
2018
First posted
Apr 19, 2017
Registry last updated
Mar 29, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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