High Fiber Rye Foods for Body Weight and Body Fat Reduction

Obesity Clinical Trial

— RyeWeight2  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04203758
• Other study ID #: RW2
• Status: Completed
• Phase: N/A
• Start date: January 20, 2020
• Est. completion date: June 8, 2021

Study information

• Verified date: July 2021
• Source: Chalmers University of Technology
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 255
• Est. completion date: June 8, 2021
• Est. primary completion date: June 8, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 30 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Body Weight
• Obesity
• Overweight

Intervention

Other:
• Cereal products based on rye
Participants will receive a fixed amount of rye based cereals products, corresponding to approx 650 kcal/day.
• Cereal products based on wheat
Participants will receive a fixed amount of wheat based cereals products, corresponding to approx 650 kcal/day.

Locations

Country	Name	City	State
Sweden	Chalmers University of Technology	Gothenburg

Sponsors (1)

Lead Sponsor	Collaborator
Chalmers University of Technology

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Investigate if there is a difference in body weight at week 12	Measured on a scale	12 weeks
Primary	Investigate if there is a difference in body fat mass at week 12	Measured by dual energy x-ray absorptiometry	12 weeks
Secondary	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.
Secondary	Investigate if differences in primary endpoints (body weight) are apparent at week 6	Measured on a scale	6 weeks
Secondary	Investigate if differences in primary endpoints (fat mass) are apparent at week 6	Measured by dual energy x-ray absorptiometry	6 weeks
Secondary	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
Secondary	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
Secondary	Investigate if fasting plasma triglycerides differ between groups		6 weeks and 12 weeks
Secondary	Investigate if fasting plasma low-density lipoprotein cholesterol differ between groups		6 weeks and 12 weeks
Secondary	Investigate if fasting plasma high-density lipoprotein cholesterol differ between groups		6 weeks and 12 weeks
Secondary	Investigate if fasting plasma total cholesterol differ between groups		6 weeks and 12 weeks
Secondary	Investigate if fasting plasma glucose differ between groups		6 weeks and 12 weeks
Secondary	Investigate if fasting serum insulin differ between groups		6 weeks and 12 weeks
Secondary	Investigate if C-reactive protein differ between groups		6 weeks and 12 weeks
Secondary	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
Secondary	Investigate if hip circumference differ between intervention groups		6 weeks and 12 weeks
Secondary	Investigate if waist circumference differ between intervention		6 weeks and 12 weeks
Secondary	Investigate if sagittal height differ between intervention groups		6 weeks and 12 weeks