- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT01526759
Fiber Longer Term Study on Energy Intake (FLiTS)
The Effect of 2 Weeks of Supplementation of a High-gelling, High-viscous Dietary Fibre on Energy Intake
Dietary fibre seems to have a relevant role in body weight management. In an acute study the investigators found that high viscous-high gelling pectin increased feelings of satiety. The objective of this study is to study the effects of 2 weeks of supplementation of high gelling-high viscous fibre or a high gelling-high viscous non-fibre control on energy intake.
The investigators do this by measuring the difference in ad libitum energy intake after 15 days of pectin or 15 days of control supplements. The investigators will further measure differences in 24h feelings of satiety, fasting blood glucose and insulin, fermentation and composition of microbiota.
Studieöversikt
Status
Betingelser
Intervention / Behandling
Studietyp
Inskrivning (Faktisk)
Fas
- Inte tillämpbar
Kontakter och platser
Studieorter
-
-
-
Wageningen, Nederländerna, 7002HD
- Wageningen University
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
Inclusion Criteria:
- Age: 18-30 year
- BMI: 18.5-25 kg/m2
- Healthy: as judged by the participant
- H2 producer
Exclusion Criteria:
- Weight loss or weight gain of more than 5 kg during the last 2 months
- Using an energy restricted diet during the last 2 months
- Lack of appetite for any reason
- Restrained eater
- Smoking
- Heavy alcohol use: >5 drinks/day
- Reported stomach or bowel diseases or disorders (e.g. irritable bowel syndrome)
- Reported diabetes
- Reported thyroid disease or any other endocrine disorder
- Using medication other than birth control, paracetamol, aspirin, hey fever and asthma
- Antibiotic use <2 months before the study
- Reported intolerance, allergy, or not liking of the research foods
- Vegetarian
- Current dietary fibre supplementation
- Fasting glucose levels >5.8 mmol/l
- Experienced any problems with drawing blood in the past
- Thesis students or employees of the division of Human Nutrition
- Volunteers who participated in the ProVe study
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Grundläggande vetenskap
- Tilldelning: Randomiserad
- Interventionsmodell: Crossover tilldelning
- Maskning: Fyrdubbla
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
---|---|
Experimentell: pectin
10 gram high gelling-high viscous fiber, added to a drink
|
15 days 1 daily consumption of a drink with 10g pectin added
|
Placebo-jämförare: control
10g gelatin, added to a drink
|
15 days 1 daily consumption of a drink with 10g gelatin added
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
Energy intake
Tidsram: change from placebo after 2 weeks
|
after 14 days of both intervention and placebo supplements ad libitum energy intake is measured for 3 days in a row.
The change in energy intake will be calculated.
|
change from placebo after 2 weeks
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
satiety
Tidsram: change from placebo after 1 day and 15 days
|
at day 1 and after 15 days of both supplement and placebo intake satiety is measured hourly over 1 day at waking hours.
The change in satiety will be calculated.
|
change from placebo after 1 day and 15 days
|
fasting glucose
Tidsram: change from placebo after day 0, 1 and 15
|
at day 0, 1 and day 15 of supplementation period fasting glucose is measured
|
change from placebo after day 0, 1 and 15
|
fasting insulin
Tidsram: change from placebo after day 0, 1 and 15
|
at day 0, 1 and day 15 of supplementation period fasting insulin is measured
|
change from placebo after day 0, 1 and 15
|
fasting leptin
Tidsram: change from placebo after day 0, 1 and 15
|
at day 0, 1 and day 15 of supplementation period fasting leptin is measured
|
change from placebo after day 0, 1 and 15
|
hydrogen in breath
Tidsram: change from placebo after day 2 and 15
|
at day 2 and at day 15 hydrogen is measured hourly over 1 day at waking hours
|
change from placebo after day 2 and 15
|
energy intake
Tidsram: change from placebo after day 0 and 1
|
before supplement intake and after 1 day of supplement 1-day ad libitum energy intake is measured.
The change in energy intake will be calculated.
|
change from placebo after day 0 and 1
|
body weight
Tidsram: change from placebo after day 0,1,2,14,15, 16 and 17
|
Each day the subject reports to the research center, body weight is measured.
The change in body weight compared to placebo will be calculated.
|
change from placebo after day 0,1,2,14,15, 16 and 17
|
adverse events
Tidsram: daily from day 0 to day 16
|
participants will be asked to register adverse events daily in a diary.
They are also asked to report ae's to the researchers.
number and type of AEs after fibre supplements will be compared to number and type of AEs after placebo supplements
|
daily from day 0 to day 16
|
Samarbetspartners och utredare
Sponsor
Utredare
- Huvudutredare: Edith Feskens, Prof, Wageningen University
Studieavstämningsdatum
Studera stora datum
Studiestart
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Uppskatta)
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Andra studie-ID-nummer
- NL38515.081.11
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