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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Obesity, Overweight

Intervention / Treatment
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* Behavioral: Almond Group
* Behavioral: Nut Free group


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Almond group<br>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<br>* Almond Group (AG) are asked to have a 30 gr. almond every day in their afternoon snack plus following the hypoenergetic diet<br>* Other names: AG group;|
| Experimental: Nut Free group<br>Nut Free group (NFG), as control group, who continue their diet without any nut consumption. | Behavioral: Nut Free group<br>* continue their diet without any nut consumption.<br>* Other names: NFG;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| weight loss | kg | 6 Month | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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almond, weight loss, Weight maintenance, hypoenergetic diet