Improvement of Metabolic Health After Thylakoid Supplementation
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|ClinicalTrials.gov Identifier: NCT02687295|
Recruitment Status : Completed
First Posted : February 22, 2016
Last Update Posted : February 22, 2016
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.
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.
|Condition or disease||Intervention/treatment||Phase|
|Metabolic Syndrome Obesity||Dietary Supplement: Thylakoids Other: Control||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||20 participants|
|Intervention Model:||Parallel Assignment|
|Primary Purpose:||Basic Science|
|Official Title:||Metabolic Risk Markers and Body Weight Are Decreased by Green-plant Supplementation in a Pilot Study With Overweight-to-obese Middle-aged Men.|
|Study Start Date :||January 2010|
|Actual Primary Completion Date :||May 2010|
|Actual Study Completion Date :||January 2016|
Placebo Comparator: Control group
Control group subjects received the same diet restriction intervention as treatment group. However, their food products did not contain any active component.
Other Name: Placebo
Active Comparator: Thylakoid group
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.
Dietary Supplement: Thylakoids
- Body weight [ Time Frame: 3 months ]
- Waist circumference [ Time Frame: 3 months ]
- Blood lipids [ Time Frame: 3 months ]Total cholesterol, LDL, HDL and TAG are measured fasting every fourth week.
- P-glucose and p-insulin [ Time Frame: 3 months ]P-glucose, p-insulin and HbA1c are measured fasting every fourth week.
- Inflammatory markers [ Time Frame: 3 months ]CRP and TNF alpha are measured fasting every fourth week.
- Appetite regulating hormones [ Time Frame: 3 months ]Ghrelin and leptin are measured fasting every fourth week.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02687295
|Principal Investigator:||Eva-Lena Stenblom, M.D.||Lund University, Region Skane|