Clinical trial NCT03097237: High Fiber Rye Foods for Weight and Body Fat Reduction
Official title: High Fiber Rye Foods for Weight and Body Fat Reduction
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Overweight
Obesity
Lead sponsor: Swedish University of Agricultural Sciences
Sponsor class: OTHER
First posted: 2017-03-31
Enrollment: 242
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 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Difference in body weight
timeFrame: 12 weeks
measure: Difference in body fat mass
timeFrame: 12 weeks
Secondary outcomes:
measure: Appetite measured by visual analogue scale (VAS) questionnaire
timeFrame: 12 weeks
measure: Difference in body weight and body fat mass
timeFrame: 6 weeks
measure: Fecal energy excretion by bomb calorimetry of 72h quantitative fecal collections.
timeFrame: 12 weeks
measure: Gut microbiota
timeFrame: 6 and 12 weeks
measure: Marker of glucose metabolism
timeFrame: 6 and 12 weeks
measure: Marker of Insulin resistance
timeFrame: 6 and 12 weeks
measure: Appetite regulation
timeFrame: 6 and 12 weeks
measure: Appetite
timeFrame: 6 and 12 weeks
measure: Marker of inflammation
timeFrame: 6 and 12 weeks
measure: Blood lipids
timeFrame: 6 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, Dr
role: PRINCIPAL_INVESTIGATOR
References:
citation: Iversen KN, Carlsson F, Andersson A, Michaelsson K, Langton M, Riserus U, Hellstrom PM, Landberg R. A hypocaloric diet rich in high fiber rye foods causes greater reduction in body weight and body fat than a diet rich in refined wheat: A parallel randomized controlled trial in adults with overweight and obesity (the RyeWeight study). Clin Nutr ESPEN. 2021 Oct;45:155-169. doi: 10.1016/j.clnesp.2021.07.007. Epub 2021 Jul 24.