Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The overall aim is to investigate whether there is a difference between methods when a standardized visual analogue scale is used to measure appetite in the home-setting compared to a monitored clinical setting. Furthermore, the intention is to investigate differences in appetite response between diets based on rye or wheat products, as well as the effects on postprandial metabolic response to such diets. Lastly, the effect of venous blood collection on subjective appetite response will be evaluated.
A human dietary intervention study will be conducted at clinical facilities in Gothenburg. The study will be a randomized crossover trial where 30 overweight, but healthy men and women will be recruited. The overall aim is to investigate whether there is a difference between methods when a standardized visual analogue scale (VAS) is used to measure appetite in the home-setting compared to a monitored clinical setting. Furthermore, the intention is to investigate difference in appetite response between diets based on rye or wheat products, as well as the effects on postprandial metabolic response to such diets. Lastly, the effect of venous blood collection on subjective appetite response will be evaluated.
Participants will be complete 3 clinic-based appetite assessments and 2 home-based appetite assessments in random order. The intervention diets will include a fixed amount of rye or wheat cereal products (approx. 650 kcal) as part of a hypocaloric diet with 500 kcal deficit, irrespective of energy requirements of the individual. Participants will follow a standardized meal plan, incorporating intervention products according to their allocation. The meal plan will consist of a breakfast consisting of puffs with milk. The lunch will consist of tomato soup with crisp bread and cheese/jam, and afternoon snack will consist of crisp bread with cheese/jam. Finally, the dinner will consist of goulash soup with soft or crisp bread and jam/cheese. The participants will be provided with all foods needed for this meal plan. During the day participants will need to answer questions about their appetite every 30 minutes from 8:00 to 12:00 and every 60 minutes from 13:00 to 21:00. These questionnaires with VAS will provide data for the comparison of home-setting and monitored clinical setting as well as appetite response between diets.
One out of the three clinic-based assessment days will include continues blood sampling throughout the day allowing evaluation of subjective appetite response on venous blood collection. Also, blood samples will be analyzed for concentration of appetite regulating hormones; glucagon-like peptide-1 (GLP-1), cholecystokinin (CCK) and ghrelin. Furthermore, insulin and triglyceride concentration will be measured as well as exploratory analysis of metabolome, short chain fatty acids (SCFA), epigenetics and gene expression analyses. Baseline fecal samples will be collected and analyzed for composition of the gut microbiome as well as short chain fatty acids (SCFA). Participants will wear a so-called continuous glucose monitors CGM allowing analysis of postprandial blood glucose throughout all 5 appetite assessment days. Measurement of physical activity will be done using Acti-Watches throughout the intervention.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Wheat home-based | Experimental |
| |
| Rye home-based | Experimental |
| |
| Rye clinic-based | Experimental |
| |
| Wheat clinic-based | Experimental |
| |
| Wheat/Rye clinic-based with blood sampling | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Wheat home-based appetite assessment | Other | Home-based appetite assessment with diet based on wheat cereal products. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Appetite assessment: hunger | Appetite will be measured through visual analogue scales 1-100mm, filled in by the participants throughout the assessment days. | Throughout the appetite assessment days ,13 hours. |
| Appetite assessment: fullness | Appetite will be measured through visual analogue scales 1-100mm, filled in by the participants throughout the assessment days. | Throughout the appetite assessment days ,13 hours. |
| Appetite assessment: desire to eat | Appetite will be measured through visual analogue scales 1-100mm, filled in by the participants throughout the assessment days. | Throughout the appetite assessment days ,13 hours. |
| Measure | Description | Time Frame |
|---|---|---|
| Body weight | Body weight is measured after an overnight fast. | Through study completion, an average of 5 weeks. |
| Height | The participant is measured to the nearest 0.5 cm without shoes. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Rikard Landberg, Dr | Chalmers University of Technology | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Gothenburg, Department of Food and Nutrition and Sport Science | Gothenburg | 41251 | Sweden |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39515756 | Derived | Aberg S, Webb DL, Nordin E, Hellstrom PM, Landberg R. Postprandial Effects of Four Test Meals Containing Wholegrain Rye or Refined Wheat Foods on Circulating Incretins, Ghrelin, Glucose, and Inflammatory Markers. J Nutr. 2025 Jan;155(1):185-196. doi: 10.1016/j.tjnut.2024.10.046. Epub 2024 Nov 6. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Rye home-based appetite assessment | Other | Home-based appetite assessment with diet based on rye cereal products. |
|
| Wheat clinic-based appetite assessment | Other | Clinic-based appetite assessment with diet based on wheat cereal products. |
|
| Rye clinic-based appetite assessment | Other | Clinic-based appetite assessment with diet based on rye cereal products. |
|
| Rye/Wheat clinic-based appetite assessment with blood sampling | Other | Clinic-based appetite assessment with diet based on rye or wheat cereal products and continuous blood sampling. |
|
| Height is measured at baseline. |
| Continuous glucose measurement | Interstitial blood glucose will be measured continuously throughout the intervention with so called continuous glucose monitors CGM, and glucose data for all 5 appetite assessment days will be analyzed. | Throughout the appetite assessment days ,13 hours. |
| Physical activity | Physical activity will be measured throughout the intervention using Acti-Watches. | Throughout the appetite assessment days ,13 hours. |
| Postprandial glucose response | Postprandial blood samples will be analyzed. | Throughout the appetite assessment days ,13 hours. |
| Gut microbiome | Fecal samples will be collected and analyzed for composition of the gut microbiome | Gut microbiome is measured at baseline. |
| Effect of continous blood sampling on subjective appetite response | Appetite assessment measured through visual analogue scales will be compared between testdays at the clinic with and without continuous blood sampling. | Throughout the appetite assessment days ,13 hours. |
| Investigate differences in appetite response between rye- and wheat-based diets | Appetite will be measured through visual analogue scales 1-100mm and scores from rye-based diets and wheat-based diets will be compared. | Throughout the appetite assessment days ,13 hours. |
| Insulin | Postprandial blood samples will be analyzed. | Throughout the appetite assessment days ,13 hours. |
| Glucagon-like peptide-1 (GLP-1) | Postprandial blood samples will be analyzed. | Throughout the appetite assessment days ,13 hours. |
| Ghrelin | Postprandial blood samples will be analyzed. | Throughout the appetite assessment days ,13 hours. |
| Cholecystokinin (CCK) | Postprandial blood samples will be analyzed. | Throughout the appetite assessment days ,13 hours. |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D009765 | Obesity |
| D001070 | Appetitive Behavior |
| ID | Term |
|---|---|
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001522 | Behavior, Animal |
| D001519 | Behavior |
Not provided
Not provided
| ID | Term |
|---|---|
| D001800 | Blood Specimen Collection |
| ID | Term |
|---|---|
| D013048 | Specimen Handling |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D011677 | Punctures |
| D013514 | Surgical Procedures, Operative |
| D008919 | Investigative Techniques |
Not provided
Not provided