Trial Outcomes & Findings for Dietary Recommendations for Reducing Free Sugar Intakes (NCT NCT04816955)
NCT ID: NCT04816955
Last Updated: 2025-06-10
Results Overview
Percentage energy intake from free sugars, assessed using diet diaries
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
242 participants
Primary outcome timeframe
12 weeks from baseline
Results posted on
2025-06-10
Participant Flow
Participant milestones
| Measure |
Nutrient-based Recommendations
Participants in this group will be given nutrient-based recommendations to reduce free sugar intakes.
Dietary recommendations: Dietary recommendations, with increasing additional behavioural/practical advice or no dietary recommendations
|
Nutrient- and Food-based Recommendations
Participants in this group will be given nutrient- and food-based recommendations to reduce free sugar intakes.
Dietary recommendations: Dietary recommendations, with increasing additional behavioural/practical advice or no dietary recommendations
|
Nutrient- and Food-based Recommendations With Food Swaps
Participants in this group will be given nutrient- and food-based recommendations and advice on food swaps to reduce free sugar intakes.
Dietary recommendations: Dietary recommendations, with increasing additional behavioural/practical advice or no dietary recommendations
|
Control
Participants in this group will not be given any recommendations to reduce free sugar intakes.
Dietary recommendations: Dietary recommendations, with increasing additional behavioural/practical advice or no dietary recommendations
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
61
|
60
|
63
|
58
|
|
Overall Study
COMPLETED
|
52
|
53
|
54
|
41
|
|
Overall Study
NOT COMPLETED
|
9
|
7
|
9
|
17
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Dietary Recommendations for Reducing Free Sugar Intakes
Baseline characteristics by cohort
| Measure |
Nutrient-based Recommendations
n=61 Participants
Participants in this group will be given nutrient-based recommendations to reduce free sugar intakes.
Dietary recommendations: Dietary recommendations, with increasing additional behavioural/practical advice or no dietary recommendations
|
Nutrient- and Food-based Recommendations
n=60 Participants
Participants in this group will be given nutrient- and food-based recommendations to reduce free sugar intakes.
Dietary recommendations: Dietary recommendations, with increasing additional behavioural/practical advice or no dietary recommendations
|
Nutrient- and Food-based Recommendations With Food Swaps
n=63 Participants
Participants in this group will be given nutrient- and food-based recommendations and advice on food swaps to reduce free sugar intakes.
Dietary recommendations: Dietary recommendations, with increasing additional behavioural/practical advice or no dietary recommendations
|
Control
n=58 Participants
Participants in this group will not be given any recommendations to reduce free sugar intakes.
Dietary recommendations: Dietary recommendations, with increasing additional behavioural/practical advice or no dietary recommendations
|
Total
n=242 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
42.4 years
STANDARD_DEVIATION 14 • n=99 Participants
|
38.3 years
STANDARD_DEVIATION 12.2 • n=107 Participants
|
42.5 years
STANDARD_DEVIATION 13.4 • n=206 Participants
|
41.7 years
STANDARD_DEVIATION 12.6 • n=7 Participants
|
41.3 years
STANDARD_DEVIATION 13.1 • n=31 Participants
|
|
Sex: Female, Male
Female
|
54 Participants
n=99 Participants
|
52 Participants
n=107 Participants
|
55 Participants
n=206 Participants
|
53 Participants
n=7 Participants
|
214 Participants
n=31 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=99 Participants
|
8 Participants
n=107 Participants
|
8 Participants
n=206 Participants
|
5 Participants
n=7 Participants
|
28 Participants
n=31 Participants
|
|
Race/Ethnicity, Customized
White
|
53 participants
n=99 Participants
|
50 participants
n=107 Participants
|
58 participants
n=206 Participants
|
51 participants
n=7 Participants
|
212 participants
n=31 Participants
|
|
Race/Ethnicity, Customized
Other background
|
8 participants
n=99 Participants
|
10 participants
n=107 Participants
|
5 participants
n=206 Participants
|
7 participants
n=7 Participants
|
30 participants
n=31 Participants
|
|
Region of Enrollment
United Kingdom
|
61 participants
n=99 Participants
|
60 participants
n=107 Participants
|
63 participants
n=206 Participants
|
58 participants
n=7 Participants
|
242 participants
n=31 Participants
|
|
Free sugar intakes
|
10.1 percentage of total energy intake
STANDARD_DEVIATION 5.2 • n=99 Participants
|
10.7 percentage of total energy intake
STANDARD_DEVIATION 4.8 • n=107 Participants
|
10.2 percentage of total energy intake
STANDARD_DEVIATION 4.4 • n=206 Participants
|
10.4 percentage of total energy intake
STANDARD_DEVIATION 5.1 • n=7 Participants
|
10.3 percentage of total energy intake
STANDARD_DEVIATION 4.8 • n=31 Participants
|
PRIMARY outcome
Timeframe: 12 weeks from baselinePercentage energy intake from free sugars, assessed using diet diaries
Outcome measures
| Measure |
Nutrient-based Recommendations
n=61 Participants
Participants in this group will be given nutrient-based recommendations to reduce free sugar intakes.
Dietary recommendations: Dietary recommendations, with increasing additional behavioural/practical advice or no dietary recommendations
|
Nutrient- and Food-based Recommendations
n=60 Participants
Participants in this group will be given nutrient- and food-based recommendations to reduce free sugar intakes.
Dietary recommendations: Dietary recommendations, with increasing additional behavioural/practical advice or no dietary recommendations
|
Nutrient- and Food-based Recommendations With Food Swaps
n=63 Participants
Participants in this group will be given nutrient- and food-based recommendations and advice on food swaps to reduce free sugar intakes.
Dietary recommendations: Dietary recommendations, with increasing additional behavioural/practical advice or no dietary recommendations
|
Control
n=58 Participants
Participants in this group will not be given any recommendations to reduce free sugar intakes.
Dietary recommendations: Dietary recommendations, with increasing additional behavioural/practical advice or no dietary recommendations
|
|---|---|---|---|---|
|
Free Sugar Intakes
|
7.7 percentage of total energy intake
Standard Error 0.7
|
7.4 percentage of total energy intake
Standard Error 0.7
|
7.1 percentage of total energy intake
Standard Error 0.6
|
9.2 percentage of total energy intake
Standard Error 0.7
|
PRIMARY outcome
Timeframe: 12 weeks from baselineAdherence to the recommendations provided, assessed using diet diaries and self-reported adherence
Outcome measures
| Measure |
Nutrient-based Recommendations
n=61 Participants
Participants in this group will be given nutrient-based recommendations to reduce free sugar intakes.
Dietary recommendations: Dietary recommendations, with increasing additional behavioural/practical advice or no dietary recommendations
|
Nutrient- and Food-based Recommendations
n=60 Participants
Participants in this group will be given nutrient- and food-based recommendations to reduce free sugar intakes.
Dietary recommendations: Dietary recommendations, with increasing additional behavioural/practical advice or no dietary recommendations
|
Nutrient- and Food-based Recommendations With Food Swaps
n=63 Participants
Participants in this group will be given nutrient- and food-based recommendations and advice on food swaps to reduce free sugar intakes.
Dietary recommendations: Dietary recommendations, with increasing additional behavioural/practical advice or no dietary recommendations
|
Control
n=58 Participants
Participants in this group will not be given any recommendations to reduce free sugar intakes.
Dietary recommendations: Dietary recommendations, with increasing additional behavioural/practical advice or no dietary recommendations
|
|---|---|---|---|---|
|
Number of Participants Who Adhered to the Recommendations Provided
|
38 participants
|
39 participants
|
39 participants
|
25 participants
|
SECONDARY outcome
Timeframe: 12 weeks from baselineEnergy intake, assessed using diet diaries
Outcome measures
| Measure |
Nutrient-based Recommendations
n=61 Participants
Participants in this group will be given nutrient-based recommendations to reduce free sugar intakes.
Dietary recommendations: Dietary recommendations, with increasing additional behavioural/practical advice or no dietary recommendations
|
Nutrient- and Food-based Recommendations
n=60 Participants
Participants in this group will be given nutrient- and food-based recommendations to reduce free sugar intakes.
Dietary recommendations: Dietary recommendations, with increasing additional behavioural/practical advice or no dietary recommendations
|
Nutrient- and Food-based Recommendations With Food Swaps
n=63 Participants
Participants in this group will be given nutrient- and food-based recommendations and advice on food swaps to reduce free sugar intakes.
Dietary recommendations: Dietary recommendations, with increasing additional behavioural/practical advice or no dietary recommendations
|
Control
n=58 Participants
Participants in this group will not be given any recommendations to reduce free sugar intakes.
Dietary recommendations: Dietary recommendations, with increasing additional behavioural/practical advice or no dietary recommendations
|
|---|---|---|---|---|
|
Dietary Intakes
|
1512 kcal/day
Standard Error 60
|
1466 kcal/day
Standard Error 70
|
1495 kcal/day
Standard Error 56
|
1516 kcal/day
Standard Error 56
|
SECONDARY outcome
Timeframe: 12 weeks from baselineBody Mass Index, assessed using researcher measurements or researcher-observed self-measurements
Outcome measures
| Measure |
Nutrient-based Recommendations
n=61 Participants
Participants in this group will be given nutrient-based recommendations to reduce free sugar intakes.
Dietary recommendations: Dietary recommendations, with increasing additional behavioural/practical advice or no dietary recommendations
|
Nutrient- and Food-based Recommendations
n=60 Participants
Participants in this group will be given nutrient- and food-based recommendations to reduce free sugar intakes.
Dietary recommendations: Dietary recommendations, with increasing additional behavioural/practical advice or no dietary recommendations
|
Nutrient- and Food-based Recommendations With Food Swaps
n=63 Participants
Participants in this group will be given nutrient- and food-based recommendations and advice on food swaps to reduce free sugar intakes.
Dietary recommendations: Dietary recommendations, with increasing additional behavioural/practical advice or no dietary recommendations
|
Control
n=58 Participants
Participants in this group will not be given any recommendations to reduce free sugar intakes.
Dietary recommendations: Dietary recommendations, with increasing additional behavioural/practical advice or no dietary recommendations
|
|---|---|---|---|---|
|
BMI
|
27.2 kg/m2
Standard Error 0.7
|
28.1 kg/m2
Standard Error 0.7
|
27.1 kg/m2
Standard Error 0.7
|
27.4 kg/m2
Standard Error 0.8
|
SECONDARY outcome
Timeframe: 12 weeks from baselinePreferences for various sweet foods/fluids, assessed using a taste test, where participants sample several sweet and non-sweet foods and rate them for pleasantness on a 100mm Visual Analogue Scale. Higher scores signify stronger preferences
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 12 weeks from baselineSelection of sweet foods/fluids at a given meal, assessed where participants can consume freely from a meal composed of sweet and non-sweet foods, and proportion of sweet foods consumed is measured in terms of weight consumed
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 12 weeks from baselineAttitudes towards sugar, sweeteners, and sweet-tasting foods, assessed using a questionnaire, soon to be published. Higher scores denote stronger attitudes.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline to 12 weeksAdverse events, assessed by self-report
Outcome measures
| Measure |
Nutrient-based Recommendations
n=61 Participants
Participants in this group will be given nutrient-based recommendations to reduce free sugar intakes.
Dietary recommendations: Dietary recommendations, with increasing additional behavioural/practical advice or no dietary recommendations
|
Nutrient- and Food-based Recommendations
n=60 Participants
Participants in this group will be given nutrient- and food-based recommendations to reduce free sugar intakes.
Dietary recommendations: Dietary recommendations, with increasing additional behavioural/practical advice or no dietary recommendations
|
Nutrient- and Food-based Recommendations With Food Swaps
n=63 Participants
Participants in this group will be given nutrient- and food-based recommendations and advice on food swaps to reduce free sugar intakes.
Dietary recommendations: Dietary recommendations, with increasing additional behavioural/practical advice or no dietary recommendations
|
Control
n=58 Participants
Participants in this group will not be given any recommendations to reduce free sugar intakes.
Dietary recommendations: Dietary recommendations, with increasing additional behavioural/practical advice or no dietary recommendations
|
|---|---|---|---|---|
|
Number of Participants Reporting Adverse Events
|
1 participants
|
1 participants
|
2 participants
|
1 participants
|
SECONDARY outcome
Timeframe: Baseline to 12 weeksAttitudes towards eating, assessed using the Three Factor Eating Questionnaire (Karlsson J, et al. IJO 2000; 24: 1715-1725)
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline to 12 weeksMotivations towards eating, assessed using the Food Choice Questionnaire (Steptoe et al., Appetite 1995, 25(3): 267-84). Higher scores denote stronger motivations
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline to 12 weeksQuality of Life, measured using the SF-36 questionnaire (Ware et al, 1996), where Quality of Life is assessed out of 100, where a higher score demonstrates better quality of life
Outcome measures
Outcome data not reported
Adverse Events
Nutrient-based Recommendations
Serious events: 1 serious events
Other events: 0 other events
Deaths: 0 deaths
Nutrient- and Food-based Recommendations
Serious events: 1 serious events
Other events: 0 other events
Deaths: 0 deaths
Nutrient- and Food-based Recommendations With Food Swaps
Serious events: 2 serious events
Other events: 0 other events
Deaths: 0 deaths
Control
Serious events: 1 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Nutrient-based Recommendations
n=61 participants at risk
Participants in this group will be given nutrient-based recommendations to reduce free sugar intakes.
Dietary recommendations: Dietary recommendations, with increasing additional behavioural/practical advice or no dietary recommendations
|
Nutrient- and Food-based Recommendations
n=60 participants at risk
Participants in this group will be given nutrient- and food-based recommendations to reduce free sugar intakes.
Dietary recommendations: Dietary recommendations, with increasing additional behavioural/practical advice or no dietary recommendations
|
Nutrient- and Food-based Recommendations With Food Swaps
n=63 participants at risk
Participants in this group will be given nutrient- and food-based recommendations and advice on food swaps to reduce free sugar intakes.
Dietary recommendations: Dietary recommendations, with increasing additional behavioural/practical advice or no dietary recommendations
|
Control
n=58 participants at risk
Participants in this group will not be given any recommendations to reduce free sugar intakes.
Dietary recommendations: Dietary recommendations, with increasing additional behavioural/practical advice or no dietary recommendations
|
|---|---|---|---|---|
|
General disorders
Adverse event
|
1.6%
1/61 • Number of events 1 • 12 weeks
Self-report
|
1.7%
1/60 • Number of events 1 • 12 weeks
Self-report
|
3.2%
2/63 • Number of events 2 • 12 weeks
Self-report
|
1.7%
1/58 • Number of events 1 • 12 weeks
Self-report
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place