The Focus of the Study is Healthy Volunteers Clinical Trial
Official title:
Appetite Ratings, Postprandial Glucose, Insulin and Gastrointestinal Hormone Responses After the Intake of an Enriched Fiber and Protein Breakfast Soft Bread in Healthy Adults
The aim of this study is to evaluate the appetite rating of a soft bread with a high content of fibre and protein (Puravita Breakfast®) as well as its capacity to modulate postprandial levels of glucose, insulin and gastrointestinal hormones involved in appetite control and insulin secretion in healthy adult volunteers.
A total of 30 healthy adults (17 males and 13 females) ranging from 19 to 32 years old (mean
age 25 ± 1), with a body mass index (BMI) ranging from 19.2 to 28.5 (mean BMI 23.3 ± 0.5)
(normal to moderately overweight) participated in this study. To avoid the risk of reaching
false conclusions, psychometric validations of food restrictions were determined for all
subjects using the revised version of the Three Factor Eating Questionnaire.
This study was carried out according to EFSA requirements [Blundell et al., 2010]. The
subjects were instructed to refrain from alcohol and/or from performing difficult physical
activities 48 h prior to each test day. The evening before the test day, the subjects
consumed a standardised dinner supplied by the study team. The meal consisted of pizza and
pineapple juice (800 kcal: protein 18%E, fat 22%E and carbohydrate 60%E). The subjects were
instructed to not eat or drink anything other than half a litre of water after the dinner.
After 20 min of resting, on the first day of intervention, anthropometric measurements
(weight, height and waist circumference) were collected on subjects wearing only underwear
and after emptying their bladder. On each day of the study, a fasting blood sample was
acquired after the resting time, and appetites were assessed with a visual analogue scale
(VAS).
The subjects were instructed to consume the tested breakfast (the soft roll bread or the
control bread plus jam and margarine) within 10 min and were allowed to drink 150 ml of
water. The subjects immediately completed two VASs, one on meal palatability and another on
appetite feelings. In addition, the appetite feeling VAS was repeated every 30 min until a
total of 4 h had passed.
The subjects were not allowed to eat or drink anything else during the 4 h of the
intervention. They were allowed to read, study, talk or listen to quiet music, but they were
not allowed to sleep. After the last blood extraction (4 h), an ad libitum lunch consisting
of a standardised spaghetti Bolognese (17%E protein, 34%E fat and 49%E carbohydrate) and
water (300 ml) was provided. The subjects were instructed to eat until comfortably
satisfied. Food intake was registered by differences in spaghetti weight before and after
lunch, and the energy intake was calculated afterwards. After the ad libitum lunch, the
subjects completed two VASs, one on meal palatability and another on appetite feelings. The
participants completed a 48-h dietary survey diary, including the food intake during the day
before and the day of the intervention.
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Single Blind (Investigator), Primary Purpose: Prevention
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Recruiting |
NCT06224569 -
Understanding the Effects of Daily Tea Consumption on Attention, Sleep, and Mood, in Healthy Adults
|
N/A |