The Effects of Including Almonds in a Weight Loss Trial

Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02360787
• Other study ID #: 055-030
• Status: Completed
• Phase: N/A
• First received: November 20, 2014
• Last updated: January 16, 2018
• Start date: October 2012
• Est. completion date: August 2017

Study information

• Verified date: January 2018
• Source: Purdue University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: August 2017
• Est. primary completion date: May 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Obesity
• Overweight

Intervention

Behavioral:
• Energy restriction

• Almonds (15% kcal/day)

Locations

Country	Name	City	State
United States	Purdue University	West Lafayette	Indiana

Sponsors (2)

Lead Sponsor	Collaborator
Purdue University	Almond Board of California

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Anthropometric measurements	Changes in body weight, BMI, fat mass, waist circumference and abdominal height over 12 weeks	12 weeks
Primary	Blood pressure	Blood pressure measurements assessed at baseline, week-4, week-8 and week-12	12 weeks
Primary	Post-lunch cognitive function	Cognitive function assessments will be performed after a standard lunch at baseline and week 12	12 weeks
Secondary	Fasting blood biochemistries	Fasting glucose, insulin, lipids and vitamin E over 12 weeks	12 weeks
Secondary	Dietary intake	Dietary intakes assessed at baseline, week-1, week-2, week-3, week-4, week-6, week-8 and week-10	10 weeks
Secondary	Appetite ratings	Appetite ratings assessed at baseline, week-4, week-8 and week-12	12 weeks
Secondary	Physical activity	Physical activity assessed at baseline, week-4, week-8 and week-12	12 weeks