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

Primary Purpose

Obesity, Overweight

Status
Completed
Phase
Not Applicable
Locations
Iran, Islamic Republic of
Study Type
Interventional
Intervention
Almond Group
Nut Free group
Sponsored by
Novindiet Clinic
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Obesity focused on measuring almond, weight loss, Weight maintenance, hypoenergetic diet

Eligibility Criteria

18 Years - 45 Years (Adult)FemaleAccepts Healthy Volunteers

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.

Sites / Locations

  • NovinDiet Clinic

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Almond group

Nut Free group

Arm 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.

Outcomes

Primary Outcome Measures

weight loss
kg

Secondary Outcome Measures

Waist circumference
cm
Fasting blood glucose
mmol/l
Fasting insulin level
mU/l
HbA1c
HOMA-IR
percentage (%)
lipid profiles
mmol/l
liver function
U/l

Full Information

First Posted
May 27, 2017
Last Updated
March 13, 2019
Sponsor
Novindiet Clinic
Collaborators
University of Nottingham, Tehran University of Medical Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT03171948
Brief Title
Effects of a Limited Almond Consumption After a Weight Loss Plan on Weight Maintenance
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
Study Type
Interventional

2. Study Status

Record Verification Date
January 2019
Overall Recruitment Status
Completed
Study Start Date
June 10, 2017 (Actual)
Primary Completion Date
December 12, 2018 (Actual)
Study Completion Date
January 17, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novindiet Clinic
Collaborators
University of Nottingham, Tehran University of Medical Sciences

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity, Overweight
Keywords
almond, weight loss, Weight maintenance, hypoenergetic diet

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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
Allocation
Randomized
Enrollment
120 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Almond group
Arm Type
Experimental
Arm Description
Almond Group (AG) are asked to have a 30 gr. almond every day in their afternoon snack plus following the hypoenergetic diet
Arm Title
Nut Free group
Arm Type
Experimental
Arm Description
Nut Free group (NFG), as control group, who continue their diet without any nut consumption.
Intervention Type
Behavioral
Intervention Name(s)
Almond Group
Other Intervention Name(s)
AG group
Intervention Description
Almond Group (AG) are asked to have a 30 gr. almond every day in their afternoon snack plus following the hypoenergetic diet
Intervention Type
Behavioral
Intervention Name(s)
Nut Free group
Other Intervention Name(s)
NFG
Intervention Description
continue their diet without any nut consumption.
Primary Outcome Measure Information:
Title
weight loss
Description
kg
Time Frame
6 Month
Secondary Outcome Measure Information:
Title
Waist circumference
Description
cm
Time Frame
6 Month
Title
Fasting blood glucose
Description
mmol/l
Time Frame
6 Month
Title
Fasting insulin level
Description
mU/l
Time Frame
6 Month
Title
HbA1c
Time Frame
6 Month
Title
HOMA-IR
Description
percentage (%)
Time Frame
6 Month
Title
lipid profiles
Description
mmol/l
Time Frame
6 Month
Title
liver function
Description
U/l
Time Frame
6 Month

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Facility Information:
Facility Name
NovinDiet Clinic
City
Tehran
Country
Iran, Islamic Republic of

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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

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