Clinical trial NCT04203758: High Fiber Rye Foods for Body Weight and Body Fat Reduction
Official title: High Fiber Rye Foods for Body Weight and Body Fat Reduction - The RyeWeight2 Study, a Randomized Controlled Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Overweight
Lead sponsor: Chalmers University of Technology
Sponsor class: OTHER
First posted: 2019-12-18
Enrollment: 255
Sex: ALL
Minimum age (years): 30
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The overall aim of this study is to investigate whether a diet rich in rye fiber from wholegrain rye, compared to refined wheat, as part of a hypo-caloric diet leads to larger weight loss and lower body fat content after 12 weeks of intervention.


Eligibility criteria: Inclusion Criteria:

* Men and women
* Age 30-70 y
* BMI 27-35 kg/m2
* Hemoglobin ≥117g/l for women and for men ≥134g/l
* Thyroid stimulating hormone (TSH) ≤4.30 mIU/L
* Low density lipoprotein (LDL) cholesterol ≤5.30 mmol/L
* Triglycerides ≤2.60 mmol/L
* Signed informed consent

Exclusion Criteria:

* Blood donation or participation in a clinical study with blood sampling within 30 days prior to screening visit and throughout the study
* Unable to satisfactorily complete the 3-day weighted food record between screening visits.
* Unable to lose ≥0.5 kg during the run-in period for men and women not having menstruation during the run-in period
* Increased body weight, despite reported adherence to dietary intake for women with menstruation during the run-in period.
* Using nicotine products on a daily basis (incl. chewing gum, patches, snus etc.)
* Using e-cigarettes (regardless of nicotine content)
* Following any weight reduction program or having followed one during the last 6 months prior to visit 1.
* Diastolic blood pressure 105 mmHg or more at visit 1
* Systolic blood pressure 160 mmHg or more at visit 1
* History of stomach or gastrointestinal conditions (Inflammatory bowel disease, Crohn's disease, malabsorption, colostomy, bowel resection, gastric bypass surgery etc.)
* More than 10 hours physical activity per week
* History of heart failure or heart attack within 1 year prior to screening
* Having type I diabetes
* Receiving pharmacological treatment for type II diabetes (treatments based on life style interventions are acceptable, as long as they are compatible with the study protocol)
* Previous gastrointestinal surgery, with the exception of minor surgeries such removal of appendix or gall bladder at least 6 months prior to screening.
* Thyroid disorder
* History of eating disorder
* History of drug or alcohol abuse
* Stroke or transient ischemic attack (TIA) within 1 year prior to screening
* Consumption of drugs aimed at weight management or drugs affecting body weight to a degree that is considered unsuitable for study participation by responsible physician.
* Pregnant, lactation or planning a pregnancy within the timeframe of the study. Pregnancy must have ended at least 6 months prior to screening, and lactation must have ended at least 1 month prior to screening.
* Food allergies or intolerances preventing consumption of any products included in the study
* Strict vegetarian (participants must be able to consume the standardized meals used for appetite assessment)
* Unable to sufficiently understand written and spoken Swedish to provide written consent and understand information and instructions from the study personal.
* Lack of suitability for participation in the study, for any reason, as judged by the medical doctor or PI.

Primary outcomes:
measure: Investigate if there is a difference in body weight at week 12
timeFrame: 12 weeks
measure: Investigate if there is a difference in body fat mass at week 12
timeFrame: 12 weeks
Secondary outcomes:
measure: Investigate if there are differences in subjective appetite ratings
timeFrame: 0 weeks, 6 weeks and 12 weeks.
measure: Investigate if differences in primary endpoints (body weight) are apparent at week 6
timeFrame: 6 weeks
measure: Investigate if differences in primary endpoints (fat mass) are apparent at week 6
timeFrame: 6 weeks
measure: Investigate if lean body mass differs between intervention groups after 6 and 12 weeks of intervention
timeFrame: 6 weeks and 12 weeks
measure: Investigate if abdominal fat mass differs between intervention groups after 6 and 12 weeks of intervention
timeFrame: 6 weeks and 12 weeks
measure: Investigate if fasting plasma triglycerides differ between groups
timeFrame: 6 weeks and 12 weeks
measure: Investigate if fasting plasma low-density lipoprotein cholesterol differ between groups
timeFrame: 6 weeks and 12 weeks
measure: Investigate if fasting plasma high-density lipoprotein cholesterol differ between groups
timeFrame: 6 weeks and 12 weeks
measure: Investigate if fasting plasma total cholesterol differ between groups
timeFrame: 6 weeks and 12 weeks
measure: Investigate if fasting plasma glucose differ between groups
timeFrame: 6 weeks and 12 weeks
measure: Investigate if fasting serum insulin differ between groups
timeFrame: 6 weeks and 12 weeks
measure: Investigate if C-reactive protein differ between groups
timeFrame: 6 weeks and 12 weeks
measure: Investigate if gut microbiota composition is affected by the intervention
timeFrame: 6 weeks and 12 weeks
measure: Investigate if hip circumference differ between intervention groups
timeFrame: 6 weeks and 12 weeks
measure: Investigate if waist circumference differ between intervention
timeFrame: 6 weeks and 12 weeks
measure: Investigate if sagittal height differ between intervention groups
timeFrame: 6 weeks and 12 weeks
Other outcomes:
Locations:
city: Gothenburg
country: Sweden
facility: Chalmers University of Technology
Study officials:
affiliation: Chalmers University of Technology
name: Rikard Landberg, PhD
role: PRINCIPAL_INVESTIGATOR
References: