Lack of Satiety, Hyperphagia
Conditions
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.
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).
Interventions
OTHERAlmonds
Whole raw almonds provided as a mid-morning snack - 0.9g\\kg
OTHERCheese Savouries
Cheese savoury crackers provided as a mid-morning snack - 0.9g/kg
Sponsors
Almond Board of California
University of Leeds
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 55 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Test Meal Energy Intake | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Food Preference | 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. |
| Appetite Sensations (Hunger) | 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. |
| 24 Hour Energy Intake | 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. |
Participant flow
Recruitment details
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
Participants by arm
| Arm | Count |
|---|---|
| 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. | 42 |
| Total | 42 |
Baseline characteristics
| Characteristic | Overall Sample |
|---|---|
| Age, Continuous | 26.0 Years STANDARD_DEVIATION 7.9 |
| Binge Eating Scale | 10.1 units on a scale STANDARD_DEVIATION 5.7 |
| BMI | 22.0 kg/m^2 STANDARD_DEVIATION 2 |
| Body Fat Percentage | 26.0 % STANDARD_DEVIATION 6.7 |
| Fat Free Mass | 43.0 kg STANDARD_DEVIATION 4.1 |
| Fat Mass | 15.4 kg STANDARD_DEVIATION 5 |
| Sex: Female, Male Female | 42 Participants |
| Sex: Female, Male Male | 0 Participants |
| Three Factor Eating Questionnaire - Disinhibition subscale | 7.6 units on a scale STANDARD_DEVIATION 2.8 |
| Three factor Eating Questionnaire - Hunger subscale | 6.1 units on a scale STANDARD_DEVIATION 3.2 |
| Three Factor Eating Questionnaire - Restraint subscale | 9.4 units on a scale STANDARD_DEVIATION 4.8 |
| Waist | 73.5 cm STANDARD_DEVIATION 5.6 |
| Weight | 58.5 kg STANDARD_DEVIATION 6.1 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk |
|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 0 / 7 | 0 / 7 | 0 / 7 | 0 / 7 | 0 / 7 | 0 / 7 |
| serious Total, serious adverse events | 0 / 7 | 0 / 7 | 0 / 7 | 0 / 7 | 0 / 7 | 0 / 7 |
Outcome results
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.
Time frame: 3 Weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Almonds | Test Meal Energy Intake | 1007.3 kcal | Standard Deviation 299.1 |
| Cheese Savouries | Test Meal Energy Intake | 1019.6 kcal | Standard Deviation 345.6 |
| No Food | Test Meal Energy Intake | 1143.4 kcal | Standard Deviation 347.4 |
p-value: <0.01ANOVA
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.
Time frame: 3 Weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Almonds | 24 Hour Energy Intake | 2992.0 kcal | Standard Deviation 654.2 |
| Cheese Savouries | 24 Hour Energy Intake | 2990.6 kcal | Standard Deviation 748.9 |
| No Food | 24 Hour Energy Intake | 2797.2 kcal | Standard Deviation 728.2 |
Comparison: Energy intake measured by ad-libitum test meals (breakfast, lunch, dinner) during each intervention condition.~Null hypothesis is that there was no difference in total energy intake between almonds, cheese savouries and no food.p-value: <0.05ANOVA
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.
Time frame: 3 Weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Almonds | Appetite Sensations (Hunger) | 11207.2 minutues*mm | Standard Deviation 5915.9 |
| Cheese Savouries | Appetite Sensations (Hunger) | 13328.0 minutues*mm | Standard Deviation 6342.6 |
| No Food | Appetite Sensations (Hunger) | 14638.4 minutues*mm | Standard Deviation 5288.2 |
p-value: <0.001ANOVA
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.
Time frame: 3 Weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Almonds | Food Preference | 10.56 units on a scale | Standard Deviation 30.6 |
| Cheese Savouries | Food Preference | 5.45 units on a scale | Standard Deviation 40.1 |
| No Food | Food Preference | 20.30 units on a scale | Standard Deviation 27.7 |
p-value: <0.05ANOVA