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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT02480582
Other study ID # LDS-2015-ABC
Secondary ID RG.PSYC.102933
Status Active, not recruiting
Phase N/A
First received June 4, 2015
Last updated December 2, 2015
Start date June 2015
Est. completion date December 2015

Study information

Verified date December 2015
Source University of Leeds
Contact n/a
Is FDA regulated No
Health authority United Kingdom: Research Ethics Committee
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 42
Est. completion date December 2015
Est. primary completion date November 2015
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years to 55 Years
Eligibility Inclusion Criteria:

- 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).

Exclusion Criteria:

- 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.

Study Design

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Single Blind (Subject), Primary Purpose: Basic Science


Related Conditions & MeSH terms


Intervention

Other:
Almonds

Cheese Savouries


Locations

Country Name City State
n/a

Sponsors (2)

Lead Sponsor Collaborator
University of Leeds Almond Board of California

References & Publications (2)

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. Epub 2007 Jun 28. — View Citation

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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 No
Primary 24 Hour Energy Intake Measured reductions in total within-day 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, at every test meal, to determine energy intake. Total energy intake will then be calculated. 24 hour energy intake will be measured on three occasions, on average a week apart. 3 Weeks No
Primary Appetite Sensations Measured reductions in hunger and increase in satiety quotient following consumption of almonds as a mid-morning snack compared to control and comparator. Appetite sensations will be assessed throughout the day using 100-mm VAS presented on the validated EARS-II (Gibbons, Caudwell, Finlayson, King & Blundell, 2011). Appetite sensations will be measured on three occasions, on average a week apart. 3 Weeks No
Primary Food Preference Measured changes in liking and wanting profiles for food following consumption of almonds as a mid-morning snack compared to control and comparator. Food preference will be assessed using the Leeds Food Preference Questionnaire (LFPQ: Finlayson, King & Blundell, 2008). Food preference will be measured on three occasions, on average a week apart. 3 Weeks No
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