Skip to main content
OpenTrials
Completed

NCT Number: NCT03097237

High Fiber Rye Foods for 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 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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Overweight Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Pathological Conditions, Signs and Symptoms Signs and Symptoms

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

  • 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.

Treatment and study plan

Wholegrain rye

Other

Cereal products based on wholegrain rye

refined wheat

Other

Cereal products based on refined wheat

Other names: Control

Primary outcomes

  1. Difference in body weight

    Time frame: 12 weeks

  2. Difference in body fat mass

    Time frame: 12 weeks

Secondary outcomes

  1. Appetite measured by visual analogue scale (VAS) questionnaire

    Time frame: 12 weeks

    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.

  2. Difference in body weight and body fat mass

    Time frame: 6 weeks

    Investigate if differences in body weight and body fat mass is evident already after 6 weeks

  3. Fecal energy excretion by bomb calorimetry of 72h quantitative fecal collections.

    Time frame: 12 weeks

    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.

  4. Gut microbiota

    Time frame: 6 and 12 weeks

  5. Marker of glucose metabolism

    Time frame: 6 and 12 weeks

    Investigate differences in hemoglobin A1c (HbA1c)

  6. Marker of Insulin resistance

    Time frame: 6 and 12 weeks

    Investigate differences in homeostatic model assessment insulin resistance (HOMA-IR)

  7. Appetite regulation

    Time frame: 6 and 12 weeks

    Investigate differences in glucagon-like peptide 1(GLP-1)

  8. Appetite

    Time frame: 6 and 12 weeks

    Investigate differences in leptin concentration

  9. Marker of inflammation

    Time frame: 6 and 12 weeks

    Investigate differences in C-reactive protein (CRP).

  10. Blood lipids

    Time frame: 6 and 12 weeks

    Investigate differences in triglyceride (TG), total cholesterol, high density lipoprotein(HDL) and low density lipoprotein (LDL).

Sponsors and collaborators

Lead sponsor

Swedish University of Agricultural Sciences

Other

Registry information

Acronym: RyeWeight

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Mar 31, 2017
Registry last updated
Jan 8, 2019

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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.