High Fiber Rye Foods for Body Weight and Body Fat Reduction

Study Overview
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Brief Summary
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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.

Official Title
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High Fiber Rye Foods for Body Weight and Body Fat Reduction - The RyeWeight2 Study, a Randomized Controlled Trial.

Conditions
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Obesity, Overweight

Intervention / Treatment
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* Other: Cereal products based on rye
* Other: Cereal products based on wheat


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 70 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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Wholegrain rye products with a high content of dietary fiber<br>Cereal products based on wholegrain rye | Other: Cereal products based on rye<br>* Participants will receive a fixed amount of rye based cereals products, corresponding to approx 650 kcal/day.<br>|
| Active Comparator: Refined wheat products with a low content of dietary fiber<br>Cereal products based on refined wheat | Other: Cereal products based on wheat<br>* Participants will receive a fixed amount of wheat based cereals products, corresponding to approx 650 kcal/day.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Investigate if there is a difference in body weight at week 12 | Measured on a scale | 12 weeks | 
| Investigate if there is a difference in body fat mass at week 12 | Measured by dual energy x-ray absorptiometry | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Investigate if there are differences in subjective appetite ratings | Measured by visual analogue scale (assessing hunger fullness and desire to eat), throughout a whole day (8:00-21:00), at baseline, week 6 and week 12. | 0 weeks, 6 weeks and 12 weeks. | 
| Investigate if differences in primary endpoints (body weight) are apparent at week 6 | Measured on a scale | 6 weeks | 
| Investigate if differences in primary endpoints (fat mass) are apparent at week 6 | Measured by dual energy x-ray absorptiometry | 6 weeks | 
| Investigate if lean body mass differs between intervention groups after 6 and 12 weeks of intervention | Measured by dual energy x-ray absorptiometry | 6 weeks and 12 weeks | 
| Investigate if abdominal fat mass differs between intervention groups after 6 and 12 weeks of intervention | Measured by dual energy x-ray absorptiometry | 6 weeks and 12 weeks | 
| Investigate if fasting plasma triglycerides differ between groups |  | 6 weeks and 12 weeks | 
| Investigate if fasting plasma low-density lipoprotein cholesterol differ between groups |  | 6 weeks and 12 weeks | 
| Investigate if fasting plasma high-density lipoprotein cholesterol differ between groups |  | 6 weeks and 12 weeks | 
| Investigate if fasting plasma total cholesterol differ between groups |  | 6 weeks and 12 weeks | 
| Investigate if fasting plasma glucose differ between groups |  | 6 weeks and 12 weeks | 
| Investigate if fasting serum insulin differ between groups |  | 6 weeks and 12 weeks | 
| Investigate if C-reactive protein differ between groups |  | 6 weeks and 12 weeks | 
| Investigate if gut microbiota composition is affected by the intervention | Gut microbiota composition will be analyzed using 16S ribosomal ribonucleic acid (rRNA) sequencing | 6 weeks and 12 weeks | 
| Investigate if hip circumference differ between intervention groups |  | 6 weeks and 12 weeks | 
| Investigate if waist circumference differ between intervention |  | 6 weeks and 12 weeks | 
| Investigate if sagittal height differ between intervention groups |  | 6 weeks and 12 weeks |