High Fiber Rye Foods for 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 hypocaloric diet leads to larger weight loss and lower body fat content after 12 weeks of intervention. Furthermore the study will investigate the effect on appetite as a potential underlying mechanism for differences in weight loss and body fat reduction.

Official Title
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High Fiber Rye Foods for Weight and Body Fat Reduction

Conditions
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Overweight, Obesity

Intervention / Treatment
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* Other: Wholegrain rye
* Other: Refined wheat


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: BMI 27-35 kg/m2 Hb≥120g/l Serum thyroid stimulating hormone (TSH) ≤4.00 mIU/L Plasma low density lipoprotein cholesterol <5.3 mmol/L Plasma triglycerides ≤1.8 mmol/L Signed informed consent Freezer capacity for 2 weeks bread provision 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 complete satisfactorily the 3-day weighted food record at screening visit 2. Unable to lose 0.5 kg or more 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 mm Hg at visit 1 Systolic blood pressure 160 mm 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 Have 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 Thyroid 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 (will be included in the list of allowed/disallowed medications) Pregnant or lactating or wish to become pregnant during the period of the study. Food allergies or intolerances Vegetarian (due to the standardized meals for appetite measurements) Unable to understand written and spoken Swedish Lack of suitability for participation in the trial, 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<br>Wholegrain rye products with a high content of dietary fiber | Other: Wholegrain rye<br>* Cereal products based on wholegrain rye<br>|
| Active Comparator: Refined wheat<br>Refined wheat products with a low content of dietary fiber | Other: Refined wheat<br>* Cereal products based on refined wheat<br>* Other names: Control;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Difference in body weight |  | 12 weeks | 
| Difference in body fat mass |  | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Appetite measured by visual analogue scale (VAS) questionnaire | Investigate if satiety differs between groups after 12 weeks of intervention and investigate if appetite correlates with changes in body weight. Measurements will be conducted through visual analogue scale (VAS) questionnaire, where participants log into a homepage and respond to their perceived satiety, hunger and desire to eat every 30-60 min during a day at base line, after 6w and 12wk. | 12 weeks | 
| Difference in body weight and body fat mass | Investigate if differences in body weight and body fat mass is evident already after 6 weeks | 6 weeks | 
| Fecal energy excretion by bomb calorimetry of 72h quantitative fecal collections. | Investigate differences in fecal energy excretion between the two intervention groups in a subgroup of 50 subjects. Every subject will be instructed to collect all feces in a special devise during 48h. | 12 weeks | 
| Gut microbiota |  | 6 and 12 weeks | 
| Marker of glucose metabolism | Investigate differences in hemoglobin A1c (HbA1c) | 6 and 12 weeks | 
| Marker of Insulin resistance | Investigate differences in homeostatic model assessment insulin resistance (HOMA-IR) | 6 and 12 weeks | 
| Appetite regulation | Investigate differences in glucagon-like peptide 1(GLP-1) | 6 and 12 weeks | 
| Appetite | Investigate differences in leptin concentration | 6 and 12 weeks | 
| Marker of inflammation | Investigate differences in C-reactive protein (CRP). | 6 and 12 weeks | 
| Blood lipids | Investigate differences in triglyceride (TG), total cholesterol, high density lipoprotein(HDL) and low density lipoprotein (LDL). | 6 and 12 weeks |