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Improvement of Metabolic Health After Thylakoid Supplementation

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02687295
Enrollment
20
Registered
2016-02-22
Start date
2010-01-31
Completion date
2016-01-31
Last updated
2016-02-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Metabolic Syndrome, Obesity

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.

Interventions

DIETARY_SUPPLEMENTThylakoids
OTHERControl

Sponsors

Lund University
CollaboratorOTHER
Region Skane
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
MALE
Age
40 Years to 70 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frame
Body weight3 months

Secondary

MeasureTime frameDescription
Waist circumference3 months
Blood lipids3 monthsTotal cholesterol, LDL, HDL and TAG are measured fasting every fourth week.
P-glucose and p-insulin3 monthsP-glucose, p-insulin and HbA1c are measured fasting every fourth week.
Inflammatory markers3 monthsCRP and TNF alpha are measured fasting every fourth week.
Appetite regulating hormones3 monthsGhrelin and leptin are measured fasting every fourth week.

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026