The Effects of Sea Buckthorn and Strawberry on Postprandial Glycaemia, Insulinemia and Appetite (OPUS-WP3C)

University of Copenhagen

Status and phase: Completed; Early Phase 1

Conditions: Glucose Intolerance; Insulin Sensitivity

Treatments: Other: Meal sequence 1-3-2; Other: Meal sequence 1-2-3; Other: Meal sequence 3-1-2; Other: Meal sequence 3-2-1; Other: Meal sequence 2-1-3; Other: Meal sequence 2-3-1

Study type: Interventional

Funder types: Other

Identifiers

NCT02412995

M208

Details and patient eligibility

About

The effects of strawberry and sea buckthorn on postprandial glycaemia and insulinemia as well as on metabolic profiles were examined in overweight or obese male subjects. The study was conducted as a randomised, controlled, single-blinded, 3-way crossover study. Eighteen subjects were studied in three 2 h meal tests followed by a subsequent ad libitum meal. Test meals contained either sea buckthorn, strawberry or no berries and added sucrose to match with respect to sucrose content. Blood samples were collected at baseline and several times postprandially. Subjective appetite sensations were recorded at baseline and every 15-20 min until 140 min and a subsequent ad libitum intake was recorded. Urine samples were also collected at baseline and at several time intervals until 24 hours. Blood and urine were subjected to metabolic profiling to investigate potential biomarkers of berry intake.

Full description

Purpose: Berries and mixed berry products exert acute effects on postprandial glycaemia and insulinemia, but very few berries have been studied, and primarily in normal weight subjects. Sea buckthorn and strawberry are compositionally widely different berries and may likely produce different responses. The effects of strawberry and sea buckthorn on postprandial glycaemia and insulinemia were examined in overweight or obese male subjects. Subjective appetite sensations and ad libitum intake were also examined. Berries may thus improve health in longer studies; however, accurate assessment of berry intake is still problematic. The discovery of objective biomarkers for intake of berries is therefore important in assessing both intake and compliance. The investigators aimed to identify urinary exposure markers of two very different berries, strawberry and sea buckthorn, in humans.

Methods: The study was conducted as a randomised, controlled, single-blinded, 3-way crossover study. Eighteen subjects were studied in three 2 h meal tests followed by a subsequent ad libitum meal. Test meals contained either sea buckthorn, strawberry or no berries and added sucrose to match with respect to sucrose content. Blood samples were collected at t = 0, 30, 45, 60, 90 and 120 min. Subjective appetite sensations were recorded at t = 0, 15, 30, 45, 60, 90, 120 and 140 min and subsequent ad libitum intake was recorded. Statistical differences in all continuous measures were evaluated based on the existence of a meal or a time-meal interaction by repeated measurements analyses or differences in the area under the curve (AUC) for that measure in a linear mixed model. Urine samples were collected on each test day at t=-15min, t=0-1h, t=1-2h, and t=2-24h and were analyzed by untargeted metabolomics. Multivariate analysis was applied to discover markers, followed by molecular fragmentation to ease their chemical identification.

Enrollment: 18 patients

Sex: Male

Ages: 20 to 50 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Healthy, male, aged 20-50 years and body mass index (BMI) 25-35 kg/m2

Exclusion criteria

• Any current or chronic clinical conditions
• Chronic/frequent use of medication
• Smoking
• Blood donation
• High level of strenuous physical activity (>10h/week)
• High habitual alcohol consumption (>14 drinks/week)
• Present or previous drug abuse
• Participation in other human intervention studies, and obesity surgery

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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18 participants in 6 patient groups

Meal sequence 1-2-3

Experimental group

Description:

The three meals, sea buckthorn puree, strawberry puree, or placebo (sugar drink) were allocated a number (1-3) in a blinded fashion and given to the participants in the order 1-2-3

Treatment:

Other: Meal sequence 1-2-3

Meal sequence 1-3-2

Experimental group

Description:

The three meals, sea buckthorn puree, strawberry puree, or placebo (sugar drink) were allocated a number (1-3) in a blinded fashion and given to the participants in the order 1-3-2

Treatment:

Other: Meal sequence 1-3-2

Meal sequence 2-3-1

Experimental group

Description:

The three meals, sea buckthorn puree, strawberry puree, or placebo (sugar drink) were allocated a number (1-3) in a blinded fashion and given to the participants in the order 2-3-1

Treatment:

Other: Meal sequence 2-3-1

Meal sequence 2-1-3

Experimental group

Description:

The three meals, sea buckthorn puree, strawberry puree, or placebo (sugar drink) were allocated a number (1-3) in a blinded fashion and given to the participants in the order 2-1-3

Treatment:

Other: Meal sequence 2-1-3

Meal sequence 3-1-2

Experimental group

Description:

The three meals, sea buckthorn puree, strawberry puree, or placebo (sugar drink) were allocated a number (1-3) in a blinded fashion and given to the participants in the order 3-1-2

Treatment:

Other: Meal sequence 3-1-2

Meal sequence 3-2-1

Experimental group

Description:

The three meals, sea buckthorn puree, strawberry puree, or placebo (sugar drink) were allocated a number (1-3) in a blinded fashion and given to the participants in the order 3-2-1

Treatment:

Other: Meal sequence 3-2-1