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


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Verified May 2017 by Novindiet Clinic

Sponsor:

Collaborators:

University of Nottingham

Tehran University of Medical Sciences

Information provided by (Responsible Party):

Novindiet Clinic

ClinicalTrials.gov Identifier:

NCT03171948

First received: May 27, 2017

Last updated: May 27, 2017

Last verified: May 2017

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.

Obesity
Overweight
Behavioral: Almond Group
Behavioral: Nut Free group

Study Type: Interventional
Study Design: 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: 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

Primary Outcome Measures:

  • weight loss [ Time Frame: 6 Month ]

    kg

Secondary Outcome Measures:

  • Waist circumference [ Time Frame: 6 Month ]

    cm

  • Fasting blood glucose [ Time Frame: 6 Month ]

    mmol/l

  • Fasting insulin level [ Time Frame: 6 Month ]

    mU/l

  • HbA1c [ Time Frame: 6 Month ]
  • HOMA-IR [ Time Frame: 6 Month ]

    percentage (%)

  • lipid profiles [ Time Frame: 6 Month ]

    mmol/l

  • liver function [ Time Frame: 6 Month ]

    U/l

Estimated Enrollment: 120
Anticipated Study Start Date: May 2017
Estimated Study Completion Date: May 2018
Estimated Primary Completion Date: February 2018 (Final data collection date for primary outcome measure)
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

Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes

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.

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT03171948

NovinDiet Clinic
Tehran, Iran, Islamic Republic of
Contact: Ameneh Madjd, Pharm D    00982122263002    mbxsama@nottingham.ac.uk   
Contact: Hamidreza Farshchi, MD, PhD    00982122263002    hrfarshchi@gmail.com   

Novindiet Clinic

University of Nottingham

Tehran University of Medical Sciences

Responsible Party: Novindiet Clinic
ClinicalTrials.gov Identifier: NCT03171948     History of Changes
Other Study ID Numbers: ND-205
Study First Received: May 27, 2017
Last Updated: May 27, 2017
Individual Participant Data  
Plan to Share IPD: Undecided

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:

Overweight
Weight Loss
Body Weight
Signs and Symptoms
Body Weight Changes

ClinicalTrials.gov processed this record on May 31, 2017