Effects of Two Doses of Thylakoids on OGTT

Region Skane

Status: Completed

Conditions: Glucose Intolerance

Treatments: Dietary Supplement: Experimental: Thylakoids 5 g; Other: Placebo Comparator: Control; Dietary Supplement: Experimental: Thylakoids 10 g

Study type: Interventional

Funder types: Other

Identifiers

NCT02702245

Thylakoid OGTT

Details and patient eligibility

About

This cross-over intervention study aims to investigate the effect of two doses of thylakoids to an oral glucose tolerance test (OGTT) on glucose and insulin homeostasis as well as appetite regulating hormones in healthy volunteers.

Full description

A minimum of twenty healthy volunteers are recruited to participate in an OGTT at three different occasions separated by one week. At two of the occasions a green leaf extract, thylakoids, is added to a glucose solution; 5 gram or 10 gram in randomized order. The third occasion, without added thylakoids, serve as control.

Blood samples are taken fasting and 15, 30, 45, 60, 90, 120 and 180 minutes after the glucose load.

Blood samples are analysed for p-glucose, p-insulin, p-C-peptide, p-ghrelin, p-CCK and p-GLP-1.

Enrollment: 21 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Healthy
• Adult
• Normal-weight and weight stable
• Not pregnant or breast-feeding
• No use of medication that can affect glucose- and insulin homeostasis (for example corticosteroids).

Exclusion criteria

• Diabetes,
• Impaired glucose tolerance and/or insulin resistance
• Anaemia
• Use of tobacco or drugs.

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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21 participants in 3 patient groups, including a placebo group

Placebo comparator: Control

Placebo Comparator group

Description:

OGTT without thylakoids.

Treatment:

Other: Placebo Comparator: Control

Experimental: Thylakoids 5 g

Experimental group

Description:

Intervention type: Dietary supplement. Supplement: thylakoid powder, dose 5 g. Intervention: OGTT at one occasion.

Treatment:

Dietary Supplement: Experimental: Thylakoids 5 g

Experimental: Thylakoids 10 g

Experimental group

Description:

Intervention type: Dietary supplement. Supplement: thylakoid powder, dose 10 g. Intervention: OGTT at one occasion.

Treatment:

Dietary Supplement: Experimental: Thylakoids 10 g