To assess the effect of a 6-month regular, low and high dietary sweetness exposure on sweetness preferences, food intake, glucose homeostasis and body weight in healthy adults.
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
smaakperceptie en voorkeur
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The difference in the change in most preferred sweetness concentration from
month 0 to month 6, measured with a preference test, between groups.
Secondary outcome
- Change in preferred sweetness intensity in a series of familiar and
unfamiliar foods from month 0 to month 1, 3, 6, 7 and 10;
- Difference in mean liking scores between familiar and unfamiliar foods at
baseline and at 1, 3, 6, 7 and 10 months;
- Change in sensory intensity scores at baseline and at 1,3, 6, 7 and 10
months;
- Change in energy intake (in kcal), measured during a test meal at baseline
and at 1, 3, 6, 7 and 10 months;
- Proportion of eaten sweet foods vs. foods from other taste modalities,
measured during a test meal at baseline and at 1, 3, 6, 7 and 10 months;
- Sweet-liker status score measured at baseline and at 1, 3, 6, 7 and 10
months;
- Food craving questionnaire scores, measured at baseline and at 1, 3, 6, 7 and
10 months;
- Taste preference questionnaire scores, measured at baseline and at 1, 3, 6, 7
and 10 months;
- Mean intake of foods based on taste modalities, measured with the Taste food
frequency questionnaire at baseline and at 1,3, 6, 7 and 10 months;
- Body weight, measured with a weighing scale at baseline and at 1, 2, 3, 4, 5,
6, 7 and 10 months;
- Waist-to-hip ratio, measured using a stretch*resistant tape at baseline and
at 1, 3, 6, 7 and 10 months;
- Body fat mass and lean body mass (fat free mass), measured with a DEXA at
baseline and at 6, and 10 months;
- Variation in interstitial glucose (e.g. mean 24h glucose, area under the
curve (AUC)) during several days, measured with glucose monitoring sensor at
baseline and at 6 and 10 months (only measured in a subgroup, of 60 subjects,
20 per intervention arm);
- Change in biomarkers related to CVD & diabetes (e.g. fasting glucose. HbA1c,
insulin, cholesterol, LDL cholesterol, HDL cholesterol, triglycerides),
measured in blood at baseline and at 1, 3, 6, 7 and 10 months;
- Adverse events;
- Compliance.
Background summary
In recent years, social pressure has been exerted towards lowering sugar and
sweetness levels in foods, with the aim of decreasing the sweetness preference
of the general population. However, the resilience/flexibility of sweetness
preferences and the impact on energy intake is a fundamental knowledge gap.
Recent, relatively long-term studies did not find a relationship between
sweetness exposure and sweetness preferences. Evidence supporting sweetness
preference alterations via variations in dietary sweetness exposure is limited.
Most studies investigating this focused only on specific sweet elements in the
diet, (e.g. beverages; mono- and disaccharides; high-energy dense snacks)
instead of sweetness in the diet as a whole. Furthermore, there is no clear
evidence about the relation between dietary sweetness exposure and weight gain.
Therefore, longer term, sufficiently-powered studies with a *whole diet*
approach are needed to address the question whether sweet preferences can be
altered (suppressed or stimulated) by variations in sweetness exposure. It is
important to answer this question so that dietary recommendations can be
tailored accordingly.
Study objective
To assess the effect of a 6-month regular, low and high dietary sweetness
exposure on sweetness preferences, food intake, glucose homeostasis and body
weight in healthy adults.
Study design
Randomized Controlled Trial with three intervention groups.Participants (n=180)
will be matched on age, gender, BMI, dietary sweetness exposure in their
habitual diet and sweet liker status and randomly allocated to one of the three
intervention arms: (1) regular dietary sweetness exposure (control) (n=60);
(2) low dietary sweetness exposure (n=60); and (3) high dietary sweetness
exposure (n=60). The intervention is semi-controlled, meaning that 50 percent
of the foods will be provided to participants. Foods are offered ad libitum, on
a weekly basis and macronutrient composition of the offered foods is similar in
energy and macronutrient composition, that is fat, protein, carbohydrates and
fibers.
Intervention
Three intervention groups:
1. Regular dietary sweetness exposure (RSE) - The RSE group consumes a diet
with 25 - 30 % energy from sweet tasting foods, for 6 months.
2. Low dietary sweetness exposure (LSE) - The LSE group consumes a diet with 10
- 15 % energy from sweet tasting foods, for 6 months.
3. High dietary sweetness exposure - The HSE group consumes a diet with 40 - 45
% energy from sweet tasting foods, for 6 months.
Study burden and risks
The risk associated with participation is negligible and the burden can be
considered as high. Subject will be required to follow allocated diet regime
for 6 months.
All foods provided to participants are commercially-available and safe for
consumption. In this study sweetness exposure will be manipulated. The three
groups will differ in sweet taste, which is not per se depending on their mono-
and disaccharide content. The HSE is more sweet and thus will contain more free
sugars and artificial sweeteners compare to the RSE and LSE diet. However, so
far it has not been proven that this do not affects energy intake, diet quality
or other health concerns (Rogers et al., 2016; Wittekind et al., 2018).
Experienced research dieticians in this study will also ensure that all three
diets contain all necessary (micro)nutrients.
Blood samples are taken by an experienced research nurse. Incidentally, a
hematoma, feelings of dizziness, nausea or fainting due to fasting can occur,
but the risks of these events are minimal. If during the study, concentration
of, for example glucose, are outside the normal range and clinically relevant,
subjects will be notified by the medical supervisor and advised to consult a
general practitioner.
The subject*s burden regarding time is as follows; 60-minutes for information
meeting, 60-minutes for screening, six times approx. 6 hours for a full-testing
session, six times 24-hour urine collection, six times 24-hour recall
(approximately 270 minutes) and approximately 125 minutes for consultation
meetings with a dietician (1 time 45 minutes, 8 times 10 minutes), in the total
period of 11 months.
Stippeneng 4
Wageningen 6708WE
NL
Stippeneng 4
Wageningen 6708WE
NL
Listed location countries
Age
Inclusion criteria
- Good general health (self reported);
- Age 18 - 65 years;
- Body mass index 18.5 - 30 kg/m^2;
- Normal taste ability (assessed with taste strips test);
- Able to provide informed consent;
- Able to attend Wageningen University, as required for testing.
Exclusion criteria
- Diagnosed with diabetes currently or in the past;
- Has been notified to have insulin resistance currently or in the past;
- Diagnosed with endocrine diseases or other metabolic diseases that influence
metabolism;
- Diagnosed with eating disorders;
- Diagnosed with taste or smell disorders;
- Pregnant or lactating during the study intervention;
- Gain or loss of more than 3 kg in the last 3 months prior to study entry;
- Suffering from lack of appetite (self-reported);
- Use of medication that may influence study results; such as medication that
may affect blood sugar (medication use will be judged by medical investigator
and self-reported);
- Having a food allergy or/and food intolerance for foods used in the
preference testing (e.g. lactose intolerance, celiac disease, egg allergy)
- Participants who use soft- and hard drug;
- Participants who drink more than 14 glasses of alcohol per week;
- Student or personnel of Nutrition and Health at Wageningen University;
- Participating in another study/studies or planning to participate in another
study.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| ClinicalTrials.gov | NCT04497974 |
| CCMO | NL72134.081.19 |