Improvement of Metabolic Health After Thylakoid Supplementation

Not Applicable

Completed

• Conditions: Metabolic Syndrome; Obesity
• Interventions: Dietary Supplement: Thylakoids; Other: Control

• Registration Number: NCT02687295
• Lead Sponsor: Region Skane

Brief Summary

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

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 Timeline

• Study Start: 2010-01
• Primary Completion: 2010-05
• Study Completion: 2016-01
• Status Verified: 2016-02
• Study First Submitted: 2016-02-10
• Study First Submitted QC: 2016-02-16
• Last Update Submitted: 2016-02-16
• Study First Posted: 2016-02-22
• Last Update Posted: 2016-02-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 20

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Thylakoid group	Thylakoids	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.
Control group	Control	Control group subjects received the same diet restriction intervention as treatment group. However, their food products did not contain any active component.

Primary Outcome Measures

Name	Time	Method
Body weight	3 months

Secondary Outcome Measures

Name	Time	Method
Blood lipids	3 months	Total cholesterol, LDL, HDL and TAG are measured fasting every fourth week.
Inflammatory markers	3 months	CRP and TNF alpha are measured fasting every fourth week.
Appetite regulating hormones	3 months	Ghrelin and leptin are measured fasting every fourth week.
Waist circumference	3 months
P-glucose and p-insulin	3 months	P-glucose, p-insulin and HbA1c are measured fasting every fourth week.