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| Name | Class |
|---|---|
| Lund University | OTHER |
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Objective:
The purpose of this study was to investigate the possible effects of green-plant thylakoid supplementation to a restricted diet intervention study in overweight to obese men.
Methods:
Overweight-obese men (BMI 25 - 35) were treated to a 30 E% restricted diet for one month, followed by one month of stabilization. Then they were divided in two treatment arms of one month each; one thylakoid-enriched diet (n=10) and one control diet (n=10). Body measurements and blood samples were taken throughout the study.
Twenty healthy, non-vegetarian, non-smoking Caucasian men were included in the study. Inclusion criteria: men aged 40 to 70 years with a BMI of 25 to 35. Exclusion criteria: Metabolic disturbances, bariatric surgery, recent diet, food allergies or treatment with antibiotics. The study protocol was approved by the Ethical Committee of Lund University, Sweden (#2006/361).
The trial consisted of three periods: 1) diet-restriction period (one month) 2) stabilizing period (one month) 3) diet-restriction period with supplementation of thylakoids or placebo (one month). The two weight-losing periods included strict diet recommendation with -30 energy % (E%), and macronutrient composition: 55-65 E% carbohydrates, 10-15 E% protein and 25-35 E% fat. Sixty minutes of low intensive exercise per day was also required.
During the stabilizing month participants were instructed to eat a healthy diet to be able to keep their achieved weight-loss.
Day 0, 28, 56 and 84 the participants arrived after 12-hour fasting for blood sampling and anthropometric measurements. The blood samples were analyzed for plasma-glucose, insulin, HbA1c, inflammation markers, cholecystokinin, ghrelin, total cholesterol, LDL-cholesterol, HDL-cholesterol, and triacylglycerol.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control group | Placebo Comparator | Control group subjects received the same diet restriction intervention as treatment group. However, their food products did not contain any active component. |
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| Thylakoid group | Active Comparator | Thylakoid group subjects received the same diet restriction intervention as the control group. However, their food products did contain an active component in the form of thylakoid powder. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Thylakoids | Dietary Supplement |
|
| |
| Measure | Description | Time Frame |
|---|---|---|
| Body weight | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Waist circumference | 3 months | |
| Blood lipids | Total cholesterol, LDL, HDL and TAG are measured fasting every fourth week. | 3 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Eva-Lena Stenblom, M.D. | Lund University, Region Skane | Principal Investigator |
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| ID | Term |
|---|---|
| D024821 | Metabolic Syndrome |
| D009765 | Obesity |
| ID | Term |
|---|---|
| D007333 | Insulin Resistance |
| D006946 | Hyperinsulinism |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
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| Control |
| Other |
|
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| P-glucose and p-insulin |
P-glucose, p-insulin and HbA1c are measured fasting every fourth week. |
| 3 months |
| Inflammatory markers | CRP and TNF alpha are measured fasting every fourth week. | 3 months |
| Appetite regulating hormones | Ghrelin and leptin are measured fasting every fourth week. | 3 months |
| D009750 |
| Nutritional and Metabolic Diseases |
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |