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| ID | Type | Description | Link |
|---|---|---|---|
| RG.PSYC.102933 | Other Grant/Funding Number | Almond Board of California |
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| Name | Class |
|---|---|
| Almond Board of California | OTHER |
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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.
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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). |
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| 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. |
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| 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). |
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| 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). |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Almonds | Other | Whole raw almonds provided as a mid-morning snack - 0.9g\kg |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Food Preference | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Graham Finlayson, PhD | University of Leeds | Principal Investigator |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21651803 | Background | 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. | |
| 17655972 | Background | 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. |
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Results to be written up for submission to peer-review scientific journal.
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Recruitment Start Date: June 2015
Recruitment End Date: October 2015
Responses to Study Advertisement: 303
Number of Participants Invited to Screening Session: 85
Number of Participants Screened: 49
Number of Participants Recruited: 42
Number of Participants Completed: 42
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| ID | Title | Description |
|---|---|---|
| FG000 | Almond, Then No Food, Then Cheese Savouries | Participants first received a mid-morning snack of almonds. 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. |
| FG001 | Cheese Savouries Then Almond, Then No Food | Participants first received a mid-morning snack of cheese savouries. After a washout period of 5 days, they then received a mid-morning snack of almonds. Finally, after another washout period participants received no food. |
| FG002 | 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. Finally, after another washout period participants received a mid-morning snack of almonds. |
| FG003 | Cheese Savouries, Then No Food, Then Almond | Participants first received a mid-morning snack of cheese savouries. 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. |
| FG004 | Almond, Then Cheese Savouries, Then No Food | Participants first received a mid-morning snack of almonds. After a washout period of 5 days, they then received a mid-morning snack of cheese savouries. Finally, after another washout period participants received no food. |
| FG005 | 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. Finally, after another washout period participants received a mid-morning snack of cheese savouries. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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Participants who completed all three study conditions were included in the analyses.
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| ID | Title | Description |
|---|---|---|
| BG000 | Overall Sample | Dosage was 0.9g/kg of 1) Whole raw almonds, 2) Cheese savoury crackers, 3) no food given in a randomised cross-over design with order determined by Latin square (i.e. 6 order permutations). Doses were administered once as a mid-morning snack. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Mean | Standard Deviation | kcal | 3 Weeks |
|
6 months (June 15 - November 15)
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Almond, Then No Food, Then Cheese Savouries | Participants first received a mid-morning snack of almonds. 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. Dosage was 0.9g/kg of 1) Whole raw almonds, 2) Cheese savoury crackers, 3) no food given in a randomised cross-over design with order determined by Latin square (i.e. 6 order permutations). Doses were administered once as a mid-morning snack. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr Graham Finlayson | University of Leeds | 0113 343 7601 | g.s.finlayson@leeds.ac.uk |
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| ID | Term |
|---|---|
| D006963 | Hyperphagia |
| ID | Term |
|---|---|
| D012817 | Signs and Symptoms, Digestive |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| 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. |
|
| 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). |
|
| Cheese Savouries | Other | Cheese savoury crackers provided as a mid-morning snack - 0.9g/kg |
|
| 3 Weeks |
| Appetite Sensations (Hunger) | 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 | 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 |
| 31480245 | Derived | 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. |
| Years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Weight | Mean | Standard Deviation | kg |
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| BMI | Mean | Standard Deviation | kg/m^2 |
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| Waist | Mean | Standard Deviation | cm |
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| Fat Mass | Mean | Standard Deviation | kg |
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| Fat Free Mass | Mean | Standard Deviation | kg |
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| Body Fat Percentage | Mean | Standard Deviation | % |
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| Three Factor Eating Questionnaire - Restraint subscale | Cognitive restraint over eating. Scale range: 0-21 Higher values indicate greater restraint over eating | Mean | Standard Deviation | units on a scale |
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| Three Factor Eating Questionnaire - Disinhibition subscale | Disinhibition of restraint Scale range: 0-16 Higher scores indicate worse outcome | Mean | Standard Deviation | units on a scale |
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| Three factor Eating Questionnaire - Hunger subscale | Susceptibility to hunger Scale range: 0-13 Higher scores indicate worse outcome | Mean | Standard Deviation | units on a scale |
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| Binge Eating Scale | Binge eating scale Scale range: 0-46 Higher scores indicate worse outcome | Mean | Standard Deviation | units on a scale |
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No food provided, just water |
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| Secondary | Food Preference | 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. | Posted | Mean | Standard Deviation | units on a scale | 3 Weeks |
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| Secondary | Appetite Sensations (Hunger) | 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. | Posted | Mean | Standard Deviation | minutues*mm | 3 Weeks |
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| Secondary | 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. | Posted | Mean | Standard Deviation | kcal | 3 Weeks |
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| 7 |
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| 7 |
| EG001 | Cheese Savouries Then Almond, Then No Food | Participants first received a mid-morning snack of cheese savouries. After a washout period of 5 days, they then received a mid-morning snack of almonds. Finally, after another washout period participants received no food. Dosage was 0.9g/kg of 1) Whole raw almonds, 2) Cheese savoury crackers, 3) no food given in a randomised cross-over design with order determined by Latin square (i.e. 6 order permutations). Doses were administered once as a mid-morning snack. | 0 | 7 | 0 | 7 |
| EG002 | 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. Finally, after another washout period participants received a mid-morning snack of almonds. Dosage was 0.9g/kg of 1) Whole raw almonds, 2) Cheese savoury crackers, 3) no food given in a randomised cross-over design with order determined by Latin square (i.e. 6 order permutations). Doses were administered once as a mid-morning snack. | 0 | 7 | 0 | 7 |
| EG003 | Cheese Savouries, Then No Food, Then Almond | Participants first received a mid-morning snack of cheese savouries. 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. Dosage was 0.9g/kg of 1) Whole raw almonds, 2) Cheese savoury crackers, 3) no food given in a randomised cross-over design with order determined by Latin square (i.e. 6 order permutations). Doses were administered once as a mid-morning snack. | 0 | 7 | 0 | 7 |
| EG004 | Almond, Then Cheese Savouries, Then No Food | Participants first received a mid-morning snack of almonds. After a washout period of 5 days, they then received a mid-morning snack of cheese savouries. Finally, after another washout period participants received no food. Dosage was 0.9g/kg of 1) Whole raw almonds, 2) Cheese savoury crackers, 3) no food given in a randomised cross-over design with order determined by Latin square (i.e. 6 order permutations). Doses were administered once as a mid-morning snack. | 0 | 7 | 0 | 7 |
| EG005 | 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. Finally, after another washout period participants received a mid-morning snack of cheese savouries. Dosage was 0.9g/kg of 1) Whole raw almonds, 2) Cheese savoury crackers, 3) no food given in a randomised cross-over design with order determined by Latin square (i.e. 6 order permutations). Doses were administered once as a mid-morning snack. | 0 | 7 | 0 | 7 |
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