Trial Outcomes & Findings for Repeated Sweet Breakfasts and Subsequent Sweet Food Preferences and Intakes (NCT NCT03442829)

NCT ID: NCT03442829

Last Updated: 2020-09-23

Results Overview

Ratings of three sweet and three non-sweet foods during a taste test at breakfast. Ratings measured using 100mm VAS scales for different hedonic factors - pleasure, sweetness, desire to eat). Scores range from 0-100 where 0=least and 100=greatest for each hedonic factor. Assessments made on Day 0, 7 and 21, Day 21 reported.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

54 participants

Primary outcome timeframe

3 weeks from baseline

Results posted on

2020-09-23

Participant Flow

Participant milestones

Participant milestones
Measure	Sweet Food Consumption Sweet breakfasts. Participants are asked to consume a sweet breakfast every day. All foods will be provided. Sweet food consumption: Sweet food consumption at breakfast	Non-sweet Food Consumption Non-sweet breakfasts. Participants are asked to consume a non-sweet breakfast every day. All foods will be provided. Non-sweet food consumption: Non-sweet food consumption at breakfast
Overall Study STARTED	27	27
Overall Study COMPLETED	23	25
Overall Study NOT COMPLETED	4	2

Reasons for withdrawal

Reasons for withdrawal
Measure	Sweet Food Consumption Sweet breakfasts. Participants are asked to consume a sweet breakfast every day. All foods will be provided. Sweet food consumption: Sweet food consumption at breakfast	Non-sweet Food Consumption Non-sweet breakfasts. Participants are asked to consume a non-sweet breakfast every day. All foods will be provided. Non-sweet food consumption: Non-sweet food consumption at breakfast
Overall Study Scheduling clash	3	1
Overall Study Illness unrelated to study	1	1

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Sweet Food Consumption n=27 Participants Sweet breakfasts. Participants are asked to consume a sweet breakfast every day. All foods will be provided. Sweet food consumption: Sweet food consumption at breakfast	Non-sweet Food Consumption n=27 Participants Non-sweet breakfasts. Participants are asked to consume a non-sweet breakfast every day. All foods will be provided. Non-sweet food consumption: Non-sweet food consumption at breakfast	Total n=54 Participants Total of all reporting groups
Age, Continuous	24.2 years STANDARD_DEVIATION 7.0 • n=27 Participants	23.5 years STANDARD_DEVIATION 4.4 • n=27 Participants	23.9 years STANDARD_DEVIATION 5.8 • n=54 Participants
Sex: Female, Male Female	18 Participants n=27 Participants	18 Participants n=27 Participants	36 Participants n=54 Participants
Sex: Female, Male Male	9 Participants n=27 Participants	9 Participants n=27 Participants	18 Participants n=54 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment United Kingdom	27 participants n=27 Participants	27 participants n=27 Participants	54 participants n=54 Participants
BMI	24.0 kg/m^2 STANDARD_DEVIATION 3.9 • n=27 Participants	23.2 kg/m^2 STANDARD_DEVIATION 3.2 • n=27 Participants	23.6 kg/m^2 STANDARD_DEVIATION 3.5 • n=54 Participants

PRIMARY outcome

Timeframe: 3 weeks from baseline

Population: Intention-to-Treat

Ratings of three sweet and three non-sweet foods during a taste test at breakfast. Ratings measured using 100mm VAS scales for different hedonic factors - pleasure, sweetness, desire to eat). Scores range from 0-100 where 0=least and 100=greatest for each hedonic factor. Assessments made on Day 0, 7 and 21, Day 21 reported.

Outcome measures

Outcome measures
Measure	Sweet Food Consumption n=27 Participants Sweet breakfasts. Participants are asked to consume a sweet breakfast every day. All foods will be provided. Sweet food consumption: Sweet food consumption at breakfast	Non-sweet Food Consumption n=27 Participants Non-sweet breakfasts. Participants are asked to consume a non-sweet breakfast every day. All foods will be provided. Non-sweet food consumption: Non-sweet food consumption at breakfast
Food Preferences Sweet foods	73 units on a scale Standard Error 3.1	68 units on a scale Standard Error 4.0
Food Preferences Non-sweet foods	54 units on a scale Standard Error 3.6	50 units on a scale Standard Error 3.8

PRIMARY outcome

Timeframe: 3 weeks from baseline

Population: Intention-to-Treat

Amount of sweet and non-sweet foods consumed during breakfast on test days (days 0, 7 and 21, day 21 reported)

Outcome measures

Outcome measures
Measure	Sweet Food Consumption n=27 Participants Sweet breakfasts. Participants are asked to consume a sweet breakfast every day. All foods will be provided. Sweet food consumption: Sweet food consumption at breakfast	Non-sweet Food Consumption n=27 Participants Non-sweet breakfasts. Participants are asked to consume a non-sweet breakfast every day. All foods will be provided. Non-sweet food consumption: Non-sweet food consumption at breakfast
Food Intake Percent weight consumed from sweet foods	28.5 percentage of total food consumed Standard Error 3	36 percentage of total food consumed Standard Error 4
Food Intake Percent energy consumed from sweet foods	37 percentage of total food consumed Standard Error 4	39 percentage of total food consumed Standard Error 4

SECONDARY outcome

Timeframe: 3 weeks from baseline

Population: Intention-to-Treat

Ratings of subjective perceptions (two meals). Ratings measured using 100mm VAS scales for different subjective factors - hunger, thirst, fullness. Scores range from 0-100 where 0=least and 100=greatest for each subjective factor. Assessments made on Day 0, 7 and 21, Day 21 reported.

Outcome measures

Outcome measures
Measure	Sweet Food Consumption n=27 Participants Sweet breakfasts. Participants are asked to consume a sweet breakfast every day. All foods will be provided. Sweet food consumption: Sweet food consumption at breakfast	Non-sweet Food Consumption n=27 Participants Non-sweet breakfasts. Participants are asked to consume a non-sweet breakfast every day. All foods will be provided. Non-sweet food consumption: Non-sweet food consumption at breakfast
Hunger Ratings Hunger	72 units on a scale Standard Deviation 19	68 units on a scale Standard Deviation 24
Hunger Ratings Fullness	15 units on a scale Standard Deviation 11	20 units on a scale Standard Deviation 30
Hunger Ratings Thirst	65 units on a scale Standard Deviation 30	67 units on a scale Standard Deviation 27

SECONDARY outcome

Timeframe: 3 weeks from baseline

Population: Intention-to-Treat

Ratings of three sweet and three non-sweet foods during a taste test at lunch. Measures are the same as those used at breakfast. Ratings measured using 100mm VAS scales for different hedonic factors - pleasure, sweetness, desire to eat). Scores range from 0-100 where 0=least and 100=greatest for each hedonic factor. Assessments made on Day 0, 7 and 21, Day 21 reported.

Outcome measures

Outcome measures
Measure	Sweet Food Consumption n=27 Participants Sweet breakfasts. Participants are asked to consume a sweet breakfast every day. All foods will be provided. Sweet food consumption: Sweet food consumption at breakfast	Non-sweet Food Consumption n=27 Participants Non-sweet breakfasts. Participants are asked to consume a non-sweet breakfast every day. All foods will be provided. Non-sweet food consumption: Non-sweet food consumption at breakfast
Food Preferences at Lunch Sweet foods	70 units on a scale Standard Deviation 15	67 units on a scale Standard Deviation 21
Food Preferences at Lunch Non-sweet foods	54 units on a scale Standard Deviation 21	52 units on a scale Standard Deviation 18

SECONDARY outcome

Timeframe: 3 weeks from baseline

Population: Intention-to-Treat

Amount of sweet and non-sweet foods consumed during lunch on test days (days 0, 7 and 21, day 21 reported).

Outcome measures

Outcome measures
Measure	Sweet Food Consumption n=27 Participants Sweet breakfasts. Participants are asked to consume a sweet breakfast every day. All foods will be provided. Sweet food consumption: Sweet food consumption at breakfast	Non-sweet Food Consumption n=27 Participants Non-sweet breakfasts. Participants are asked to consume a non-sweet breakfast every day. All foods will be provided. Non-sweet food consumption: Non-sweet food consumption at breakfast
Food Intake at Lunch Percent weight consumed from sweet foods	27 percentage of total food consumed Standard Deviation 17	32 percentage of total food consumed Standard Deviation 19
Food Intake at Lunch Percent energy consumed from sweet foods	33 percentage of total food consumed Standard Deviation 17	37 percentage of total food consumed Standard Deviation 22

Adverse Events

Sweet Food Consumption

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Non-sweet Food Consumption

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Prof. Katherine Appleton

Bournemouth University

Phone: 01202965985

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place