NCT01690936

Brief Summary

Identifying snacks that do not contribute to positive energy balance is crucial in weight management. The satiating effects of almonds, coupled with their convenience and palatability make them a promising weight management aid. Therefore, this study aimed to examine the effects of almond consumption with meals versus snacks on outcomes such as appetite, energy intake, body weight, as well as blood glucose, insulin and lipid responses.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
150

participants targeted

Target at P75+ for not_applicable obesity

Timeline
Completed

Started Oct 2010

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2010

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2012

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

September 12, 2012

Completed
12 days until next milestone

First Posted

Study publicly available on registry

September 24, 2012

Completed
Last Updated

May 30, 2013

Status Verified

May 1, 2013

Enrollment Period

1.7 years

First QC Date

September 12, 2012

Last Update Submit

May 28, 2013

Conditions

Obesity

Keywords

AlmondsBody weightSnacking

Outcome Measures

Primary Outcomes (4)

  • Postprandial glucose, insulin and lipids

    Responses of these parameters to a standard breakfast and a standard lunch for all participants, plus almonds at designated times according to group randomization.

    490 minutes

  • Anthropometric measurements

    Changes in body weight, BMI, fat mass, waist circumference over 4 weeks

    4 weeks

  • Fasting blood biochemistries

    Fasting glucose, insulin and lipids at baseline, week-1, 2, 3 and 4

    4 weeks

  • Dietary intake

    Dietary intakes were assessed at baseline, week-2, and week-4 of study

    4 weeks

Secondary Outcomes (3)

  • Blood pressure

    Baseline and week-4

  • Appetite ratings

    Baseline, week-2, and week-4

  • Postprandial appetite sensations

    490 minutes

Study Arms (5)

Breakfast

EXPERIMENTAL

Almonds (43g/day) were consumed with breakfast for four weeks.

Dietary Supplement: Almonds 43g/day

Morning snack

EXPERIMENTAL

Almonds (43g/day) were consumed alone as morning snacks for four weeks.

Dietary Supplement: Almonds 43g/day

Lunch

EXPERIMENTAL

Almonds (43g/day) were consumed with lunch for four weeks.

Dietary Supplement: Almonds 43g/day

Afternoon snack

EXPERIMENTAL

Almonds (43g/day) were consumed alone as afternoon snacks for four weeks.

Dietary Supplement: Almonds 43g/day

Control no nuts

NO INTERVENTION

Avoided all nuts and seeds

Interventions

Almonds 43g/dayDIETARY_SUPPLEMENT

43 grams of almonds were supplemented to the 4 intervention arms but eaten at different times of day (with meals or alone as snacks) for 4 weeks. Control group was asked to avoid all nuts/seeds during the study period

Afternoon snackBreakfastLunchMorning snack

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Not taking any medication known to affect glycemia, lipid metabolism or appetite
  • Regular breakfast consumers
  • Eat at least 5 meals a day
  • Weight stable
  • Either one of the 6 conditions
  • BMI 27-35
  • Family history of diabetes
  • Fasting glucose between 6.1-6.9 mmol/L
  • hour glucose 7.8-11.1 mmol/L
  • blood pressure \>130/85 mmHg
  • Waist \>102cm (men) and \>88cm (women)

You may not qualify if:

  • Nut allergy
  • Not willing to eat test foods and almonds

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Purdue University

West Lafayette, Indiana, 47907, United States

Location

MeSH Terms

Conditions

ObesityBody Weight

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Richard D Mattes, PhD

    Purdue University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Distinguished Prof Foods and Nutrition

Study Record Dates

First Submitted

September 12, 2012

First Posted

September 24, 2012

Study Start

October 1, 2010

Primary Completion

June 1, 2012

Study Completion

June 1, 2012

Last Updated

May 30, 2013

Record last verified: 2013-05

Locations

US(1)