Dietary Habits Clinical Trial
— Vezel-UPOfficial title:
Vezel-UP:Stimulating Fiber Intake Via Personalized Dietary Advice
Verified date | January 2021 |
Source | Wageningen University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Dietary fibers are linked to improved health and prevention of diseases such as obesity, stroke, hypertension, diabetes and colorectal cancer. Moreover, fibers play a crucial role in improving and maintaining gut health, by increasing stool weight,stool frequency and improvement of stool consistency. Currently, very few adults meet the recommendation of 30 (females) or 40 (males) grams per day. Personalized dietary advice may be the solution to increase dietary fiber intake in large populations. The objective is to investigate if a personalized dietary advice is more effective in increasing dietary fiber intake in the Dutch population than the general advice that is currently provided by the Netherlands Nutrition center and the Dutch Digestive Foundation (MLDS).Second objective is to assess the effect of increased fiber intake on stool pattern, perceived well-being and consumer behavior parameters and the role of psychological factors in the effectiveness of personalized dietary advice on dietary fiber intake. Study design: A 4.5-month (6 weeks intervention + follow-up after 3 months) single-blind randomized controlled trial with two groups: the intervention group, which receives personalized dietary advice (PDA), and the control group, which only receives the general dietary advice. Primary study parameters/outcome of the study: Primary endpoint is dietary fiber intake, which will be assessed using an Food Frequency Questionnaire and 24hr recalls. Fecal microbiota composition and metabolite levels will be used as an objective marker for fiber intake. Secondary study parameters/outcome of the study (if applicable): Secondary parameters include stool pattern, well-being, hunger, satiety and body weight. Furthermore, psychological measurements will give insight into why the PDA was (not) effective.
Status | Completed |
Enrollment | 106 |
Est. completion date | September 14, 2019 |
Est. primary completion date | September 14, 2019 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Age =18 years. - Apparently healthy: no gastrointestinal complaints, no food allergies and no medication that can influence the outcome of the study (see exclusion criteria). - Relatively low fiber intake: which is assessed by a short fiber intake screening questionnaire (score ranging from 1 to 22). Females with a score =13 and males with a score =15 will be included in the study. - Living in the surroundings of Wageningen (max. 50 km). - In possession of a mobile phone with android =4.4 or iOS system =9 to use apps. - Signed informed consent. Exclusion Criteria: - Any digestive tract disorder that is expected to interfere with the study outcomes, such as chronic constipation or diarrhea, Crohn's Disease, Ulcerative Colitis, Irritable Bowel Syndrome, Coeliac disease. - Diagnosis of Diabetes Mellitus, since the change in carbohydrate intake may interfere with medication usage. - Currently following a strict diet and unwilling or unable to change; for example a gluten free diet or a "crash diet" using meal substitutes. - Use of medication that can interfere with the study outcomes, including laxatives, diuretics, antidepressants, codeine, antibiotics or fiber supplements - Female subjects: currently pregnant or breastfeeding, or intending to become pregnant during the study, as this can affect stool patterns and well-being. - Simultaneously participating in another study. - Unwilling or unable to fulfill the study criteria. |
Country | Name | City | State |
---|---|---|---|
Netherlands | Wageningen University, Division of Human Nutrition | Wageningen |
Lead Sponsor | Collaborator |
---|---|
Wageningen University | Bolletje, Dutch Association for Gastrointestinal diseases (MLDS), Kellogg Company, Netherlands: Ministry of Health, Welfare and Sports, Sensus, Sonneveld |
Netherlands,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in dietary fiber intake | Will be measured using the Food Frequency Questionnaire, and 24hr recalls to compute grams of fiber. | Before study, after 6 weeks intervention, and 3 months follow-up | |
Primary | change in Short Chain Fatty acid level | of a fecal sample | Before study, at 3 weeks and at 6 weeks | |
Primary | change in Microbiota composition | of a fecal sample | Before study, at 3 weeks and at 6 weeks | |
Secondary | Stool pattern | Bristol stool chart en stool frequency | Daily during 6-week intervention | |
Secondary | Perceived wellbeing | Using validated questions | Daily during 6-week intervention | |
Secondary | Hunger and Satiety | Using validated questions | Daily during 6-week intervention | |
Secondary | Body weight | Subjects weigh themselves (morning, fasted) | study start, and after 6 weeks | |
Secondary | Psychological questionnaires | Validated questionnaire will be used to assess motives, barriers, knowledge, intentions, self-efficacy, self-regulation and knowledge | Before and after the 6-week intervention, and at 3-months follow-up |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT04025099 -
Internal Cues Versus External Cues for Eating and Activity
|
N/A | |
Recruiting |
NCT06094049 -
Acceptability of Folic Acid and Vitamin B12 Fortified Meals
|
||
Completed |
NCT03720314 -
Microbiota Profiling in IBS
|
||
Completed |
NCT03334266 -
Preventing Early Childhood Obesity, Part 2: Family Spirit Nurture, Prenatal - 18 Months
|
N/A | |
Recruiting |
NCT02894931 -
Effects of Dietary Interventions on Serum and Macrophage Atherogenicity
|
N/A | |
Completed |
NCT02559076 -
The Eat Right Emirates Healthy Lifestyle Study
|
N/A | |
Completed |
NCT05502445 -
The Nutritionist's Educational Intervention on the Protein Intake in Hospitalized Elderly People
|
N/A | |
Active, not recruiting |
NCT04308473 -
Analysis of MicroBial Metabolites After Eating Refined Food
|
N/A | |
Completed |
NCT04082247 -
Healthy Children 2021 Study in Childcare Centers
|
N/A | |
Recruiting |
NCT05157815 -
Study to Investigate the Effect of Dietary Fibre Supplementation on Long-term Glucose Control in Prediabetic Subjects
|
N/A | |
Active, not recruiting |
NCT05607745 -
Dietary Counseling Coupled With FMT in the Treatment of Obesity and NAFLD - the DIFTOB Study
|
N/A | |
Completed |
NCT06045845 -
Effects of Beet Juice and Diet in Female Rowers
|
N/A | |
Completed |
NCT03775889 -
Engaging School and Family in Navajo Gardening for Health
|
N/A | |
Not yet recruiting |
NCT02910128 -
Childhood Obesity Prevention Trough Education Innovation in Primary School: A Quasi-experimental Trial
|
N/A | |
Completed |
NCT03189979 -
Club Fit: Physical Activity and Healthy Eating at an After School Program
|
N/A | |
Completed |
NCT02572479 -
Evaluating the Potential of the Diet as Disease Modifier in Amyotrophic Lateral Sclerosis (JERN_ALS)
|
||
Completed |
NCT02102763 -
Greek Childhood Obesity (GRECO) Study
|
N/A | |
Completed |
NCT04632771 -
Nutritional Status and Bouillon Use in Northern Ghana
|
||
Recruiting |
NCT03500458 -
Impact of Sleep Extension in Adolescents
|
N/A | |
Completed |
NCT03673267 -
Nutricity: A Pilot Study to Improve Parental Nutrition Literacy
|
N/A |