Improvement of Metabolic Health After Thylakoid Supplementation

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Metabolic Risk Markers and Body Weight Are Decreased by Green-plant Supplementation in a Pilot Study With Overweight-to-obese Middle-aged Men.

Conditions
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Metabolic Syndrome, Obesity

Intervention / Treatment
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* Dietary Supplement: Thylakoids
* Other: Control


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy, overweight, non-vegetarian, non-smoking Exclusion Criteria: Medication for metabolic disturbances, previous bariatric surgery, diabetes, had been on diet or treated with antibiotics during last 3 months, food-allergies

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Control group<br>Control group subjects received the same diet restriction intervention as treatment group. However, their food products did not contain any active component. | Other: Control<br> <br> * Other names: Placebo;|
| Active Comparator: Thylakoid group<br>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<br> <br> * Other names: Green-plant membranes;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Body weight |  | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Waist circumference |  | 3 months | 
| Blood lipids | Total cholesterol, LDL, HDL and TAG are measured fasting every fourth week. | 3 months | 
| 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 |