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Completed

NCT Number: NCT04203758

High Fiber Rye Foods for Body Weight and Body Fat Reduction

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.

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Key information

Age range

30 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Chalmers University of Technology

Gothenburg, Sweden

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Cereal products based on rye

Other

Participants will receive a fixed amount of rye based cereals products, corresponding to approx 650 kcal/day.

Cereal products based on wheat

Other

Participants will receive a fixed amount of wheat based cereals products, corresponding to approx 650 kcal/day.

Primary outcomes

  1. Investigate if there is a difference in body weight at week 12

    Time frame: 12 weeks

    Measured on a scale

  2. Investigate if there is a difference in body fat mass at week 12

    Time frame: 12 weeks

    Measured by dual energy x-ray absorptiometry

Secondary outcomes

  1. Investigate if there are differences in subjective appetite ratings

    Time frame: 0 weeks, 6 weeks and 12 weeks.

    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.

  2. Investigate if differences in primary endpoints (body weight) are apparent at week 6

    Time frame: 6 weeks

    Measured on a scale

  3. Investigate if differences in primary endpoints (fat mass) are apparent at week 6

    Time frame: 6 weeks

    Measured by dual energy x-ray absorptiometry

  4. Investigate if lean body mass differs between intervention groups after 6 and 12 weeks of intervention

    Time frame: 6 weeks and 12 weeks

    Measured by dual energy x-ray absorptiometry

  5. Investigate if abdominal fat mass differs between intervention groups after 6 and 12 weeks of intervention

    Time frame: 6 weeks and 12 weeks

    Measured by dual energy x-ray absorptiometry

  6. Investigate if fasting plasma triglycerides differ between groups

    Time frame: 6 weeks and 12 weeks

  7. Investigate if fasting plasma low-density lipoprotein cholesterol differ between groups

    Time frame: 6 weeks and 12 weeks

  8. Investigate if fasting plasma high-density lipoprotein cholesterol differ between groups

    Time frame: 6 weeks and 12 weeks

  9. Investigate if fasting plasma total cholesterol differ between groups

    Time frame: 6 weeks and 12 weeks

  10. Investigate if fasting plasma glucose differ between groups

    Time frame: 6 weeks and 12 weeks

  11. Investigate if fasting serum insulin differ between groups

    Time frame: 6 weeks and 12 weeks

  12. Investigate if C-reactive protein differ between groups

    Time frame: 6 weeks and 12 weeks

  13. Investigate if gut microbiota composition is affected by the intervention

    Time frame: 6 weeks and 12 weeks

    Gut microbiota composition will be analyzed using 16S ribosomal ribonucleic acid (rRNA) sequencing

  14. Investigate if hip circumference differ between intervention groups

    Time frame: 6 weeks and 12 weeks

  15. Investigate if waist circumference differ between intervention

    Time frame: 6 weeks and 12 weeks

  16. Investigate if sagittal height differ between intervention groups

    Time frame: 6 weeks and 12 weeks

Sponsors and collaborators

Lead sponsor

Chalmers University of Technology

Other

Registry information

Official study title

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

Acronym: RyeWeight2

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Dec 18, 2019
Registry last updated
Jul 19, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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