Fiber Longer Term Study on Energy Intake

Study Overview
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Brief Summary
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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.

Official Title
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The Effect of 2 Weeks of Supplementation of a High-gelling, High-viscous Dietary Fibre on Energy Intake

Conditions
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Healthy

Intervention / Treatment
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* Dietary Supplement: LM pectin (10%)
* Dietary Supplement: gelatin


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 30 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: pectin<br>10 gram high gelling-high viscous fiber, added to a drink | Dietary Supplement: LM pectin (10%)<br>* 15 days 1 daily consumption of a drink with 10g pectin added<br>|
| Placebo Comparator: control<br>10g gelatin, added to a drink | Dietary Supplement: gelatin<br>* 15 days 1 daily consumption of a drink with 10g gelatin added<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Energy intake | 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| satiety | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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dietary fiber, energy intake, satiety, physicochemical properties, men and women, Healthy adults