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Completed

NCT Number: NCT02360787

The Effects of Including Almonds in a Weight Loss Trial

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.

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Key information

Conditions

Overweight Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Purdue University

West Lafayette, Indiana, 47907, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Energy restriction

Behavioral

Almonds (15% kcal/day)

Behavioral

Primary outcomes

  1. Anthropometric measurements

    Time frame: 12 weeks

    Changes in body weight, BMI, fat mass, waist circumference and abdominal height over 12 weeks

  2. Blood pressure

    Time frame: 12 weeks

    Blood pressure measurements assessed at baseline, week-4, week-8 and week-12

  3. Post-lunch cognitive function

    Time frame: 12 weeks

    Cognitive function assessments will be performed after a standard lunch at baseline and week 12

Secondary outcomes

  1. Fasting blood biochemistries

    Time frame: 12 weeks

    Fasting glucose, insulin, lipids and vitamin E over 12 weeks

  2. Dietary intake

    Time frame: 10 weeks

    Dietary intakes assessed at baseline, week-1, week-2, week-3, week-4, week-6, week-8 and week-10

  3. Appetite ratings

    Time frame: 12 weeks

    Appetite ratings assessed at baseline, week-4, week-8 and week-12

  4. Physical activity

    Time frame: 12 weeks

    Physical activity assessed at baseline, week-4, week-8 and week-12

Sponsors and collaborators

Lead sponsor

Purdue University

Other

Collaborators

  • Almond Board of California

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2016
Study completion
2017
First posted
Feb 11, 2015
Registry last updated
Jan 18, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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