- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02480582
The Impact of Snacks Which Vary Nutritionally in Their Satiating Potential on Measures of Appetite Control
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Some individuals exhibit a weak satiety response to food and may be susceptible to overconsumption. Snack foods can be substantial contributors to daily energy intake, with different types of snacks exerting potentially different effects on satiety per calorie consumed. The current study will compare the effect of consuming different snack foods on measures of appetite control including appetite sensations, energy intake and food hedonics in women with a weak satiety response.
In a crossover design, female participants will consume three different mid-morning snacks: raw almonds, savoury crackers or water. Appetite sensations, energy intake, food reward and craving will be assessed under controlled laboratory conditions. Satiety responsiveness will be determined using the satiety quotient (SQ).
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Almond, then No Food, then Cheese Savouries
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).
|
Whole raw almonds provided as a mid-morning snack - 0.9g\kg
Cheese savoury crackers provided as a mid-morning snack - 0.9g/kg
|
Experimental: Cheese Savouries then Almond, then No Food
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.
|
Whole raw almonds provided as a mid-morning snack - 0.9g\kg
Cheese savoury crackers provided as a mid-morning snack - 0.9g/kg
|
Experimental: No Food, then Cheese Savouries, then Almond
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).
|
Whole raw almonds provided as a mid-morning snack - 0.9g\kg
Cheese savoury crackers provided as a mid-morning snack - 0.9g/kg
|
Experimental: Cheese Savouries, then No Food, then Almond
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).
|
Whole raw almonds provided as a mid-morning snack - 0.9g\kg
Cheese savoury crackers provided as a mid-morning snack - 0.9g/kg
|
Experimental: Almond, then Cheese Savouries, then No Food
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.
|
Whole raw almonds provided as a mid-morning snack - 0.9g\kg
Cheese savoury crackers provided as a mid-morning snack - 0.9g/kg
|
Experimental: No Food, then Almond, then Cheese Savouries
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).
|
Whole raw almonds provided as a mid-morning snack - 0.9g\kg
Cheese savoury crackers provided as a mid-morning snack - 0.9g/kg
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Test Meal Energy Intake
Time Frame: 3 Weeks
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Food Preference
Time Frame: 3 Weeks
|
Measured changes in wanting for high fat food food following consumption of almonds as a mid-morning snack compared to control and comparator. Food preference will be measured once during each intervention condition using the Leeds Food Preference Questionnaire (LFPQ: Finlayson, King & Blundell, 2008). 8 high fat foods and 8 low fat foods are presented on a computer and participants rate the extent to which they want each food (How much do you want this food now?). The food images are presented individually, in a randomised order and participants make their ratings using a 100-mm VAS. Low fat scores are subtracted from high fat scores to provide a relative preference score. Scale range: -100 to 100. Higher scores indicate greater wanting for high fat foods which is interpreted as a worse outcome. |
3 Weeks
|
Appetite Sensations (Hunger)
Time Frame: 3 Weeks
|
Measured differences in hunger following consumption of almonds as a mid-morning snack compared to control and comparator. Appetite sensations will be measured during the three intervention conditions at regular time intervals from the morning to the evening (21 in total) using 100-mm visual analogue scale (VAS). Scale range = 0-100 mm, with higher values indicating greater hunger. Total Area Under the Curve will be calculated from the VAS profiles using the trapeziodal method. Time points at which data were collected to calculate AUC - -5, 15, 30, 60, 90, 120, 135, 180, 230, 240, 270, 280, 300, 360, 420, 480, 510, 540, 600; -5 to 8 hours post intervention. Higher AUC scores on hunger are interpreted as a worse outcome. |
3 Weeks
|
24 Hour Energy Intake
Time Frame: 3 Weeks
|
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
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Graham Finlayson, PhD, University of Leeds
Publications and helpful links
General Publications
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- LDS-2015-ABC
- RG.PSYC.102933 (Other Grant/Funding Number: Almond Board of California)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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