Trial Outcomes & Findings for The Impact of Snacks Which Vary Nutritionally in Their Satiating Potential on Measures of Appetite Control (NCT NCT02480582)

Last Updated: 2017-03-15

Results Overview

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.

Recruitment status

COMPLETED

Study phase

Target enrollment

42 participants

Primary outcome timeframe

3 Weeks

Results posted on

2017-03-15

Participant Flow

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

Participant milestones

Participant milestones
Measure	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.	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.	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.	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.	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.	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.
Overall Study STARTED	7	7	7	7	7	7
Overall Study COMPLETED	7	7	7	7	7	7
Overall Study NOT COMPLETED	0	0	0	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

The Impact of Snacks Which Vary Nutritionally in Their Satiating Potential on Measures of Appetite Control

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Overall Sample n=42 Participants 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.
Age, Continuous	26.0 Years STANDARD_DEVIATION 7.9 • n=99 Participants
Sex: Female, Male Female	42 Participants n=99 Participants
Sex: Female, Male Male	0 Participants n=99 Participants
Weight	58.5 kg STANDARD_DEVIATION 6.1 • n=99 Participants
BMI	22.0 kg/m^2 STANDARD_DEVIATION 2.0 • n=99 Participants
Waist	73.5 cm STANDARD_DEVIATION 5.6 • n=99 Participants
Fat Mass	15.4 kg STANDARD_DEVIATION 5.0 • n=99 Participants
Fat Free Mass	43.0 kg STANDARD_DEVIATION 4.1 • n=99 Participants
Body Fat Percentage	26.0 % STANDARD_DEVIATION 6.7 • n=99 Participants
Three Factor Eating Questionnaire - Restraint subscale	9.4 units on a scale STANDARD_DEVIATION 4.8 • n=99 Participants
Three Factor Eating Questionnaire - Disinhibition subscale	7.6 units on a scale STANDARD_DEVIATION 2.8 • n=99 Participants
Three factor Eating Questionnaire - Hunger subscale	6.1 units on a scale STANDARD_DEVIATION 3.2 • n=99 Participants
Binge Eating Scale	10.1 units on a scale STANDARD_DEVIATION 5.7 • n=99 Participants

PRIMARY outcome

Timeframe: 3 Weeks

Outcome measures

Outcome measures
Measure	Almonds n=42 Participants Whole, raw almonds Almonds	Cheese Savouries n=42 Participants Sainsbury's savoury biscuits Cheese Savouries	No Food n=42 Participants No food provided, just water
Test Meal Energy Intake	1007.3 kcal Standard Deviation 299.1	1019.6 kcal Standard Deviation 345.6	1143.4 kcal Standard Deviation 347.4

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Almonds n=42 Participants Whole, raw almonds Almonds	Cheese Savouries n=42 Participants Sainsbury's savoury biscuits Cheese Savouries	No Food n=42 Participants No food provided, just water
Food Preference	10.56 units on a scale Standard Deviation 30.6	5.45 units on a scale Standard Deviation 40.1	20.30 units on a scale Standard Deviation 27.7

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Almonds n=42 Participants Whole, raw almonds Almonds	Cheese Savouries n=42 Participants Sainsbury's savoury biscuits Cheese Savouries	No Food n=42 Participants No food provided, just water
Appetite Sensations (Hunger)	11207.2 minutues*mm Standard Deviation 5915.9	13328.0 minutues*mm Standard Deviation 6342.6	14638.4 minutues*mm Standard Deviation 5288.2

SECONDARY outcome

Timeframe: 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.