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

March 13, 2019 updated by: Novindiet Clinic

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

120

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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 Names:
  • 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 Names:
  • NFG

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
weight loss
Time Frame: 6 Month
kg
6 Month

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Waist circumference
Time Frame: 6 Month
cm
6 Month
Fasting blood glucose
Time Frame: 6 Month
mmol/l
6 Month
Fasting insulin level
Time Frame: 6 Month
mU/l
6 Month
HbA1c
Time Frame: 6 Month
6 Month
HOMA-IR
Time Frame: 6 Month
percentage (%)
6 Month
lipid profiles
Time Frame: 6 Month
mmol/l
6 Month
liver function
Time Frame: 6 Month
U/l
6 Month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Novindiet Clinic

Collaborators

Tehran University of Medical Sciences
University of Nottingham

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 10, 2017

Primary Completion (Actual)

December 12, 2018

Study Completion (Actual)

January 17, 2019

Study Registration Dates

First Submitted

May 27, 2017

First Submitted That Met QC Criteria

May 27, 2017

First Posted (Actual)

May 31, 2017

Study Record Updates

Last Update Posted (Actual)

March 14, 2019

Last Update Submitted That Met QC Criteria

March 13, 2019

Last Verified

January 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ND-205

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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