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Effects of a Limited Almond Consumption After a Weight Loss Plan on Weight Maintenance

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03171948
Recruitment Status : Completed
First Posted : May 31, 2017
Last Update Posted : March 14, 2019
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 this study is to assess the effects of limited portion of almond consumption after a successful weight loss by a comprehensive weight loss plan (NovinDiet Plan) on weight maintenance in obese female adults.

Condition or disease Intervention/treatment Phase
Obesity Overweight Behavioral: Almond 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
Intervention Model Description: Almond Group (AG) are asked to have a 30 gr. almond every day in their afternoon snack plus following the hypoenergetic diet Nut Free group (NFG), as control group, who continue their diet without any nut consumption.
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Effects of a Limited Almond Consumption After a Successful Weight Loss by a Comprehensive Weight Loss Plan on Weight Maintenance in Healthy Obese Female Adults: a Randomised Clinical Trial
Actual Study Start Date : June 10, 2017
Actual Primary Completion Date : December 12, 2018
Actual Study Completion Date : January 17, 2019

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Arms and Interventions
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Arm Intervention/treatment
Experimental: Almond group
Almond Group (AG) are asked to have a 30 gr. almond every day in their afternoon snack plus following the hypoenergetic diet
 Behavioral: Almond Group
Almond Group (AG) are asked to have a 30 gr. almond every day in their afternoon snack plus following the hypoenergetic diet
Other Name: AG group
Experimental: Nut Free group
Nut Free group (NFG), as control group, who continue their diet without any nut consumption.
 Behavioral: Nut Free group
continue their diet without any nut consumption.
Other Name: NFG


Outcome Measures
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Primary Outcome Measures :
  1. weight loss [ Time Frame: 6 Month ]
    kg


Secondary Outcome Measures :
  1. Waist circumference [ Time Frame: 6 Month ]
    cm

  2. Fasting blood glucose [ Time Frame: 6 Month ]
    mmol/l

  3. Fasting insulin level [ Time Frame: 6 Month ]
    mU/l

  4. HbA1c [ Time Frame: 6 Month ]
  5. HOMA-IR [ Time Frame: 6 Month ]
    percentage (%)

  6. lipid profiles [ Time Frame: 6 Month ]
    mmol/l

  7. liver function [ Time Frame: 6 Month ]
    U/l


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:

  • female
  • 18-45 years of age.
  • Body mass index (BMI) between 23-30 kg/ m² who lost at least 10% of her initial weight by the diet plan.
  • Must be able to have moderate exercise.
  • Must be interested to keep weight loss.

Exclusion Criteria:

  • No Allergy to nut products
  • Pregnancy or lactation during the previous 6 months, or planned pregnancy in the next 6 months.
  • Taking medications 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): NCT03171948


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
More Information
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Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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Responsible Party: Novindiet Clinic
ClinicalTrials.gov Identifier: NCT03171948    
Other Study ID Numbers: ND-205
First Posted: May 31, 2017    Key Record Dates
Last Update Posted: March 14, 2019
Last Verified: January 2019
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:
almond
weight loss
Weight maintenance
hypoenergetic diet
Additional relevant MeSH terms:
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Overweight
Weight Loss
Body Weight
Body Weight Changes