NCT03120455

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P50-P75 for not_applicable obesity

Timeline
Completed

Started Jun 2017

Shorter than P25 for not_applicable obesity

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 15, 2017

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 19, 2017

Completed
2 months until next milestone

Study Start

First participant enrolled

June 5, 2017

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 13, 2017

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 15, 2018

Completed
Last Updated

March 29, 2018

Status Verified

March 1, 2018

Enrollment Period

5 months

First QC Date

April 15, 2017

Last Update Submit

March 28, 2018

Conditions

ObesityOverweight

Keywords

weight lossAlmondPistachiohypoenergetic dietNut

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (7)

  • Waist circumference

    12 Weeks

  • fasting blood glucose

    12 Weeks

  • HbA1c

    12 Weeks

  • HOMA-IR

    12 Weeks

  • lipid profiles

    12 Weeks

  • +2 more secondary outcomes

Study Arms (3)

Almond group (AG)

EXPERIMENTAL

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

Pistachio group (PG)

ACTIVE COMPARATOR

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

Nut Free (NFG, CG)

PLACEBO COMPARATOR

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

Interventions

Almond GroupBEHAVIORAL

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

Also known as: AG
Almond group (AG)
Pistachio GroupBEHAVIORAL

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

Also known as: PG
Pistachio group (PG)
Nut free groupBEHAVIORAL

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

Also known as: NFG
Nut Free (NFG, CG)

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

NovinDiet Clinic

Tehran, Iran

Location

MeSH Terms

Conditions

ObesityOverweightWeight Loss

Condition Hierarchy (Ancestors)

OvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsBody Weight Changes

Study Officials

  • Hamid R Farshchi, MD, PhD

    NovinDiet Clinic, School of Life Sciences, The University of Nottingham

    STUDY CHAIR

  • Ameneh Madjd, Dr

    NovinDiet Clinic, School of Life Sciences, The University of Nottingham

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 15, 2017

First Posted

April 19, 2017

Study Start

June 5, 2017

Primary Completion

November 13, 2017

Study Completion

January 15, 2018

Last Updated

March 29, 2018

Record last verified: 2018-03

Locations

IR(1)