The Effects of Sea Buckthorn and Strawberry on Postprandial Glycaemia, Insulinemia and Appetite

Insulin Sensitivity Clinical Trial

— OPUS-WP3C  

Official title:

The Effects of Sea Buckthorn and Strawberry on Postprandial Glycaemia, Insulinemia and Appetite - A Randomised, Controlled, Crossover Study of Danish Berries in Overweight and Obese Male Subjects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02412995
• Other study ID #: M208
• Status: Completed
• Phase: Phase 0
• First received: February 8, 2015
• Last updated: April 8, 2015
• Start date: October 2012
• Est. completion date: February 2015

Study information

• Verified date: April 2015
• Source: University of Copenhagen
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Ethics CommitteeDenmark: Danish Dataprotection Agency
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: February 2015
• Est. primary completion date: November 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 20 Years to 50 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Crossover Assignment, Masking: Single Blind (Investigator), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Glucose Intolerance
• Insulin Sensitivity

Intervention

Other:
• Meal sequence 1-2-3
The subjects were studied in three 2 h meal tests with a subsequent ad libitum meal on separate days, at least two days apart. The subjects were individually randomised to the sequence of the test meals using random permutation. The study included two berry meals based on 150 g of frozen berries; sea buckthorn (Hippophaë rhamnoides) and strawberry (Fragaria x ananassa), respectively, and one control meal which did not contain berries. Each meal contained 35 g of sucrose and was adjusted for protein and fat with whey protein and canola oil, respectively. The meals were served with 120 mL of water.
• Meal sequence 1-3-2
The subjects were studied in three 2 h meal tests with a subsequent ad libitum meal on separate days, at least two days apart. The subjects were individually randomised to the sequence of the test meals using random permutation. The study included two berry meals based on 150 g of frozen berries; sea buckthorn (Hippophaë rhamnoides) and strawberry (Fragaria x ananassa), respectively, and one control meal which did not contain berries. Each meal contained 35 g of sucrose and was adjusted for protein and fat with whey protein and canola oil, respectively. The meals were served with 120 mL of water.
• Meal sequence 2-3-1
The subjects were studied in three 2 h meal tests with a subsequent ad libitum meal on separate days, at least two days apart. The subjects were individually randomised to the sequence of the test meals using random permutation. The study included two berry meals based on 150 g of frozen berries; sea buckthorn (Hippophaë rhamnoides) and strawberry (Fragaria x ananassa), respectively, and one control meal which did not contain berries. Each meal contained 35 g of sucrose and was adjusted for protein and fat with whey protein and canola oil, respectively. The meals were served with 120 mL of water.
• Meal sequence 2-1-3
The subjects were studied in three 2 h meal tests with a subsequent ad libitum meal on separate days, at least two days apart. The subjects were individually randomised to the sequence of the test meals using random permutation. The study included two berry meals based on 150 g of frozen berries; sea buckthorn (Hippophaë rhamnoides) and strawberry (Fragaria x ananassa), respectively, and one control meal which did not contain berries. Each meal contained 35 g of sucrose and was adjusted for protein and fat with whey protein and canola oil, respectively. The meals were served with 120 mL of water.
• Meal sequence 3-1-2
The subjects were studied in three 2 h meal tests with a subsequent ad libitum meal on separate days, at least two days apart. The subjects were individually randomised to the sequence of the test meals using random permutation. The study included two berry meals based on 150 g of frozen berries; sea buckthorn (Hippophaë rhamnoides) and strawberry (Fragaria x ananassa), respectively, and one control meal which did not contain berries. Each meal contained 35 g of sucrose and was adjusted for protein and fat with whey protein and canola oil, respectively. The meals were served with 120 mL of water.
• Meal sequence 3-2-1
The subjects were studied in three 2 h meal tests with a subsequent ad libitum meal on separate days, at least two days apart. The subjects were individually randomised to the sequence of the test meals using random permutation. The study included two berry meals based on 150 g of frozen berries; sea buckthorn (Hippophaë rhamnoides) and strawberry (Fragaria x ananassa), respectively, and one control meal which did not contain berries. Each meal contained 35 g of sucrose and was adjusted for protein and fat with whey protein and canola oil, respectively. The meals were served with 120 mL of water.

Locations

Country	Name	City	State
Denmark	Department of Nutrition, Exercise and Sports, University of Copenhagen	Frederiksberg C

Sponsors (2)

Lead Sponsor	Collaborator
University of Copenhagen	Nordea-fonden

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Glycemia Area under the plasma glucose concentration curve, concentration curve.	Area under the plasma glucose concentration curve, concentration curve.	postprandially 0-120min	No
Secondary	Insulin response Area under the plasma insulin concentration curve	Area under the plasma insulin concentration curve	postprandially 0-120min	No
Secondary	Appetite scores (visual analogue scale)	Measured on a 100 mm visual analogue scale spanning the sensation from minimum to maximum on the following: hunger, satiety, fullness, perceived prospective food intake, thirst, well-being, and desire for something sweet.	postprandially 0-140min	No
Secondary	urine metabolic profile	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 (UPLC-QTOF)	0-24 hrs	No
Secondary	plasma metabolic profile (metabolic profiling by UPLC-QTOF)	Blood samples were drawn at t = -20 (baseline), 30, 45, 60, 90 and 120 min on each test day and subjected to untargeted metabolic profiling by UPLC-QTOF	0-120min	No
Secondary	Meal perception VAS questionnaire	A VAS questionnaire concerning meal perception with ratings for taste (poor/good), smell (not appetising/appetising), appearance (not appetising/appetising), undertaste (none/much), and overall impression (not appetising/appetising).	postprandially at 30min and 140 min	No
Secondary	Incremental area under the plasma glucose concentration curve	The area under the initial part of the glucose plasma curve from the volunteer has ingested the sugar solution until 60 min later	postprandially, 0-30 and 0-60min	No
Secondary	Glycemic profile (calculated as the time in minutes during which the blood glucose concentration is above baseline concentration divided by the incremental peak value of blood glucose)	Gycemic profile((calculated as the time in minutes during which the blood glucose concentration is above baseline concentration divided by the incremental peak value of blood glucose)	0-120 min	No
Secondary	Incremental insulin response Incremental area under the plasma insulin concentration curve.	Incremental area under the plasma insulin concentration curve.	Postprandially 0-30 and 0-60 min	No

External Links

•   Homepage for integrated study