NCT02480582

Brief Summary

The current study will examine the effect of almond consumption (0.9g/kg dose) compared to an energy and weight matched comparator food or no food on measures of appetite control including appetite sensations, energy intake and food hedonics.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
42

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2015

Shorter than P25 for not_applicable

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2015

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

June 4, 2015

Completed
20 days until next milestone

First Posted

Study publicly available on registry

June 24, 2015

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2015

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
1.3 years until next milestone

Results Posted

Study results publicly available

March 15, 2017

Completed
Last Updated

March 15, 2017

Status Verified

January 1, 2017

Enrollment Period

5 months

First QC Date

June 4, 2015

Results QC Date

May 31, 2016

Last Update Submit

January 25, 2017

Conditions

Outcome Measures

Primary Outcomes (1)

  • Test Meal Energy Intake

    Measured reductions in ad-libitum energy intake following consumption of almonds as a mid-morning snack compared to control and comparator. Food will be weighed pre- and post-consumption to the nearest 0.1g to determine energy intake. Test meal energy intake will be measured on three occasions, on average a week apart.

    3 Weeks

Secondary Outcomes (3)

  • Food Preference

    3 Weeks

  • Appetite Sensations (Hunger)

    3 Weeks

  • 24 Hour Energy Intake

    3 Weeks

Study Arms (6)

Almond, then No Food, then Cheese Savouries

EXPERIMENTAL

Participants first received a mid-morning snack of almonds (0.9g/kg). After a washout period of 5 days, they then received no food. Finally, after another washout period participants received a mid-morning snack of cheese savouries (0.9g/kg).

Other: AlmondsOther: Cheese Savouries

Cheese Savouries then Almond, then No Food

EXPERIMENTAL

Participants first received a mid-morning snack of cheese savouries (0.9g/kg). After a washout period of 5 days, they then received a mid-morning snack of almonds (0.9g/kg). Finally, after another washout period participants received no food.

Other: AlmondsOther: Cheese Savouries

No Food, then Cheese Savouries, then Almond

EXPERIMENTAL

Participants first received no food. After a washout period of 5 days, they then received a mid-morning snack of cheese savouries (0.9g/kg). Finally, after another washout period participants received a mid-morning snack of almonds (0.9g/kg).

Other: AlmondsOther: Cheese Savouries

Cheese Savouries, then No Food, then Almond

EXPERIMENTAL

Participants first received a mid-morning snack of cheese savouries (0.9g\\kg). After a washout period of 5 days, they then received no food. Finally, after another washout period participants received a mid-morning snack of almonds (0.9g\\kg).

Other: AlmondsOther: Cheese Savouries

Almond, then Cheese Savouries, then No Food

EXPERIMENTAL

Participants first received a mid-morning snack of almonds (0.9g\\kg). After a washout period of 5 days, they then received a mid-morning snack of cheese savouries (0.9g\\kg). Finally, after another washout period participants received no food.

Other: AlmondsOther: Cheese Savouries

No Food, then Almond, then Cheese Savouries

EXPERIMENTAL

Participants first received no food. After a washout period of 5 days, they then received a mid-morning snack of almonds (0.9g/kg). Finally, after another washout period participants received a mid-morning snack of cheese savouries (0.9g\\kg).

Other: AlmondsOther: Cheese Savouries

Interventions

AlmondsOTHER

Whole raw almonds provided as a mid-morning snack - 0.9g\\kg

Almond, then Cheese Savouries, then No FoodAlmond, then No Food, then Cheese SavouriesCheese Savouries then Almond, then No FoodCheese Savouries, then No Food, then AlmondNo Food, then Almond, then Cheese SavouriesNo Food, then Cheese Savouries, then Almond

Cheese savoury crackers provided as a mid-morning snack - 0.9g/kg

Almond, then Cheese Savouries, then No FoodAlmond, then No Food, then Cheese SavouriesCheese Savouries then Almond, then No FoodCheese Savouries, then No Food, then AlmondNo Food, then Almond, then Cheese SavouriesNo Food, then Cheese Savouries, then Almond

Eligibility Criteria

Age18 Years - 55 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Participants who have provided written informed consent.
  • Healthy female participants aged 18-55 years.
  • BMI of 18.5 - 30.0 kg/m2.
  • Regular breakfast eaters.
  • Not currently dieting to lose, gain or maintain weight.
  • Non-smokers.
  • Liking/acceptance of the study foods (≥4 on 7-point Likert scale).

You may not qualify if:

  • Taking medication known to affect appetite within past month and/or during the study.
  • Any known food allergies or food intolerances.
  • Participants who do not regularly eat breakfast.
  • Participants with low liking or acceptance of the study foods.
  • Participants currently dieting to lose, gain or maintain weight.
  • Reported history of or present eating disorder.
  • BMI \<18.5 kg/m2 or \>30 kg/m2.
  • Vegetarians.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (3)

  • Gibbons C, Caudwell P, Finlayson G, King N, Blundell J. Validation of a new hand-held electronic data capture method for continuous monitoring of subjective appetite sensations. Int J Behav Nutr Phys Act. 2011 Jun 8;8:57. doi: 10.1186/1479-5868-8-57.

    PMID: 21651803BACKGROUND
  • Finlayson G, King N, Blundell J. The role of implicit wanting in relation to explicit liking and wanting for food: implications for appetite control. Appetite. 2008 Jan;50(1):120-7. doi: 10.1016/j.appet.2007.06.007. Epub 2007 Jun 28.

    PMID: 17655972BACKGROUND
  • Hollingworth S, Dalton M, Blundell JE, Finlayson G. Evaluation of the Influence of Raw Almonds on Appetite Control: Satiation, Satiety, Hedonics and Consumer Perceptions. Nutrients. 2019 Aug 30;11(9):2030. doi: 10.3390/nu11092030.

MeSH Terms

Conditions

Hyperphagia

Condition Hierarchy (Ancestors)

Signs and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and Symptoms

Results Point of Contact

Title
Dr Graham Finlayson
Organization
University of Leeds

Study Officials

  • Graham Finlayson, PhD

    University of Leeds

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

June 4, 2015

First Posted

June 24, 2015

Study Start

June 1, 2015

Primary Completion

November 1, 2015

Study Completion

December 1, 2015

Last Updated

March 15, 2017

Results First Posted

March 15, 2017

Record last verified: 2017-01

Data Sharing

IPD Sharing
Will share

Results to be written up for submission to peer-review scientific journal.