NCT02937298

Brief Summary

Weight gain occurs because of imbalances in energy balance favouring energy intake. Whilst over 50% of a person's energy requirement goes towards the maintenance of physiological functions, around 40% is used for physical activity. In addition to this, around 10-15% of energy is spent on what is termed as Diet Induced Thermogenesis (DIT). Diet Induced Thermogenesis is the increase in energy expenditure following a meal, and represents the energy utilised for the digestion and metabolism of food. Some nutrients such as proteins require more energy to digest and therefore produce a greater DIT than others. In addition to this, some food components are able to independently stimulate calorie burning. For example caffeine, chilli, ginger and green tea have been shown to induce calorie burning through DIT. Therefore the inclusion of such foods in the diet could increase energy expenditure and thereby help in weight control. The objective of this study is to determine the DIT effects of some plant foods that are native to Scotland (blackberries, blueberries, red raspberries, wild garlic and sea buckthorn). These foods have been shown to contain compounds that stimulate DIT. If found to be effective, these foods could then be used to develop dietary strategies for weight control in Scotland.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
7

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2016

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2016

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

October 14, 2016

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 18, 2016

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2017

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

May 17, 2018

Completed
Last Updated

May 18, 2018

Status Verified

May 1, 2018

Enrollment Period

1 year

First QC Date

October 14, 2016

Last Update Submit

May 17, 2018

Conditions

Keywords

Diet Induced ThermogenesisObesityEnergy balanceEnergy expenditureberriesSea BuckthornWild garlic

Outcome Measures

Primary Outcomes (1)

  • Diet Induced Thermogenesis

    Measured as the difference in Resting Metabolic Rate (RMR) during fasting and postprandial states

    Baseline then for 15 minutes hourly for 5 hours post prandial

Secondary Outcomes (2)

  • Substrate utilisation for energy metabolism

    Baseline and hourly for 5 hours post prandial

  • Satiety and palatability of the test meals.

    Immediately before and after consumption of the test meal.

Study Arms (4)

Control Meal

EXPERIMENTAL

Control meal using standard breakfast foods.

Dietary Supplement: Control Meal

Berry Treatment

EXPERIMENTAL

This will consist of standard breakfast foods plus a berry smoothie.

Dietary Supplement: Berry Treatment

Sea Buckthorn Treatment

EXPERIMENTAL

This will consist of standard breakfast foods plus a sea buckthorn berry smoothie.

Dietary Supplement: Sea Buckthorn Treatment

Wild Garlic Treatment

EXPERIMENTAL

This will consist of standard breakfast foods plus a wild garlic dip.

Dietary Supplement: Wild Garlic Treatment

Interventions

Control MealDIETARY_SUPPLEMENT

This will consist of standard breakfast foods (cereal, milk, yoghurt, cheese cracker bread, butter, banana and cream

Control Meal
Berry TreatmentDIETARY_SUPPLEMENT

This will consist of standard breakfast foods (cereal, milk, yoghurt, cheese cracker bread, butter, banana and cream plus a berry smoothie. The berry smoothie consists of blueberries, raspberries and blackberries.

Berry Treatment
Sea Buckthorn TreatmentDIETARY_SUPPLEMENT

This will consist of standard breakfast foods (cereal, milk, yoghurt, cheese cracker bread, butter, banana and cream plus a sea buckthorn berry smoothie.

Sea Buckthorn Treatment
Wild Garlic TreatmentDIETARY_SUPPLEMENT

This will consist of standard breakfast foods (cereal, milk, yoghurt, cheese cracker bread, butter, banana and cream. The wild garlic will be prepared and served as a dip alongside.

Wild Garlic Treatment

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy males and females aged between 18-50 years
  • Body mass index between 18.5 - 25.0 kg/m2

You may not qualify if:

  • Suffering from thyroid disorders, metabolic/genetic diseases
  • On prescription medications known to affect metabolism including hormonal contraceptives and thyroid medications
  • Post-menopausal
  • Allergic/intolerant to any foods
  • Eating disorders
  • Alcohol and/or other substance misuse issues
  • Extreme intake of caffeine (more than 6 cups of tea and/or coffee per day)
  • Smoking

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rowett Institute of Nutrition and Health, Human Nutrition Unit

Aberdeen, AB25 2ZD, United Kingdom

Location

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Viren Ranawana, MSc, PhD

    Rowett Institute of Nutrition and Health, University of Aberdeen, Foresterhill, Aberdeen, AB25 2ZD, United Kingdom

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 14, 2016

First Posted

October 18, 2016

Study Start

May 1, 2016

Primary Completion

May 1, 2017

Study Completion

May 17, 2018

Last Updated

May 18, 2018

Record last verified: 2018-05

Data Sharing

IPD Sharing
Will not share

Locations