The Effects of Including Almonds in a Weight Loss Trial

Not Applicable

Completed

• Conditions: Overweight; Obesity
• Interventions: Behavioral: Energy restriction; Behavioral: Almonds (15% kcal/day)

• Registration Number: NCT02360787
• Lead Sponsor: Purdue University

Brief 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.

Detailed 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.

Study Timeline

• Study Start: 2012-10
• Study First Submitted: 2014-11-20
• Study First Submitted QC: 2015-02-05
• Study First Posted: 2015-02-11
• Primary Completion: 2016-05
• Study Completion: 2017-08
• Status Verified: 2018-01
• Last Update Submitted: 2018-01-16
• Last Update Posted: 2018-01-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Energy restriction	Energy restriction	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.
Energy restriction with almonds	Energy restriction	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.
Energy restriction with almonds	Almonds (15% kcal/day)	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.

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Purdue University; 🇺🇸 West Lafayette, Indiana, United States