The Effects of Including Almonds in a Weight Loss Trial

Study Overview
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Brief Summary
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The purpose of this study is to determine whether inclusion of almonds in a weight loss regimen will augment the rate of weight loss, promote a greater fat mass/fat-free mass ratio of weight loss, improve blood pressure and ameliorate the post-lunch dip in cognitive function.

Detailed Description
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The purpose of this study is to determine whether inclusion of almonds in a weight loss regimen will augment the rate of weight loss, promote a greater fat mass/fat-free mass ratio of weight loss, improve blood pressure and ameliorate the post-lunch dip in cognitive function.

Official Title
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The Effects of Including Almonds in an Energy-restricted Diet on Weight, Abdominal Fat Loss, Blood Pressure, and Cognitive Function

Conditions
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Overweight, Obesity

Intervention / Treatment
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* Behavioral: Energy restriction
* Behavioral: Almonds (15% kcal/day)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adult participants Overweight or obese (BMI 25-40 kg/m2) Fasting blood glucose ≤6.9 mmol/L via capillary finger-stick blood samples No nut allergies Willing to comply to study protocol and to eat test meals Exclusion Criteria: Those not meeting inclusion criteria.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

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: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Energy restriction<br>Energy restriction (-500 kcal/day) (N=40), where participants will receive dietary counseling to reduce energy intake to achieve 500 kcal/day deficits to support weight loss. Participants will also be asked to avoid all nuts during the intervention period. | Behavioral: Energy restriction<br> <br> |
| Experimental: Energy restriction with almonds<br>Energy restriction (-500 kcal/day) with dry-roasted, lightly salted almonds supplying 15% of estimated energy requirement. Participants will receive dietary counseling to reduce energy intake to achieve 500 kcal/day deficits. Energy from almonds will be accounted for during dietary modeling so that a 500 kcal/day deficit is achieved. | Behavioral: Energy restriction<br> <br> Behavioral: Almonds (15% kcal/day)<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Anthropometric measurements | Changes in body weight, BMI, fat mass, waist circumference and abdominal height over 12 weeks | 12 weeks | 
| Blood pressure | Blood pressure measurements assessed at baseline, week-4, week-8 and week-12 | 12 weeks | 
| Post-lunch cognitive function | Cognitive function assessments will be performed after a standard lunch at baseline and week 12 | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fasting blood biochemistries | Fasting glucose, insulin, lipids and vitamin E over 12 weeks | 12 weeks | 
| Dietary intake | Dietary intakes assessed at baseline, week-1, week-2, week-3, week-4, week-6, week-8 and week-10 | 10 weeks | 
| Appetite ratings | Appetite ratings assessed at baseline, week-4, week-8 and week-12 | 12 weeks | 
| Physical activity | Physical activity assessed at baseline, week-4, week-8 and week-12 | 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Obesity, Almonds, Energy restriction, Body weight, Body fat, Blood pressure, Cognitive function