NCT01645995

Brief Summary

Specific policies on obesity reduction often include a recommendation to reduce sugar consumption as a means of lowering overall caloric intake. Reformulating processed foods (e.g. sugary products) is considered one of the key options for improving population diet. The implications of regular consumption of reformulated products are not fully understood. Previous studies have demonstrated that dietary compensation is common, although the extent is not fully elucidated. In addition to the perceived impact of sugar consumption on weight control, high sugar intake, specifically sucrose and fructose, has been implicated in the increase of plasma lipids and markers of insulin resistance. However to date no randomised controlled study has investigated whether the consumption of reformulated low sugar products as components of a habitual diet have a significant impact on plasma lipid, insulin or glucose concentrations within a free-living, non-diseased population. It is hypothesised that exchange of reformulated, low sugar food products for habitually consumed foods will result in dietary compensation and minimal weight change compared with unmodified products and will have little impact on plasma glucose, insulin and lipid levels.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable type-2-diabetes-mellitus

Timeline
Completed

Started Mar 2012

Shorter than P25 for not_applicable type-2-diabetes-mellitus

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2012

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

July 18, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 20, 2012

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2013

Completed
Last Updated

December 4, 2014

Status Verified

December 1, 2014

Enrollment Period

1 year

First QC Date

July 18, 2012

Last Update Submit

December 3, 2014

Conditions

Type 2 Diabetes MellitusCardiovascular DiseaseObesity

Outcome Measures

Primary Outcomes (1)

  • Changes in body weight and body composition

    20 weeks. Baseline and week 8 assessments for two dietary intervention arms

Secondary Outcomes (6)

  • Changes in energy and nutrient intake

    20 weeks. Run-in period and week 7 assessments for two dietary intervention arms

  • Changes in appetite and mood ratings

    20 weeks. Run-in period and week 7 assessments for two dietary intervention arms

  • Changes in physical activity levels

    20 weeks. Run-in period and week 7 assessments for two dietary intervention arms

  • Changes in fasting plasma lipid, insulin and glucose concentrations

    20 weeks. Baseline and week 8 assessments for two dietary intervention arms

  • Changes in vascular stiffness by pulse wave analysis (PWA) and digital volume pulse (DVP)

    20 weeks. Baseline and week 8 assessments for two dietary intervention arms

  • +1 more secondary outcomes

Study Arms (2)

Reformulated products

EXPERIMENTAL

Subjects were asked to supplement their habitual diet with reformulated sugar-reduced products for 8 weeks. Subjects were provided with reformulated beverages, sauces, condiments and snacks. They were asked to consume a minimum of 1 drink + 1 food portion intervention supplement daily, in exchange for habitually eaten equivalent foods.

Dietary Supplement: Reformulated products

Conventional products

EXPERIMENTAL

Subjects were asked to supplement their habitual diet with conventional sugar products for 8 weeks. Subjects were provided with conventional beverages, sauces, condiments and snacks. They were asked to consume a minimum of 1 drink + 1 food portion intervention supplement daily, in exchange for habitually eaten equivalent foods.

Dietary Supplement: Conventional products

Interventions

Reformulated productsDIETARY_SUPPLEMENT

Subjects were asked to supplement their habitual diet with reformulated sugar-reduced products for 8 weeks. Subjects were provided with reformulated beverages, sauces, condiments and snacks. They were asked to consume a minimum of 1 drink + 1 food portion intervention supplement daily, in exchange for habitually eaten equivalent foods.

Also known as: REF
Reformulated products
Conventional productsDIETARY_SUPPLEMENT

Subjects were asked to supplement their habitual diet with conventional sugar products for 8 weeks. Subjects were provided with conventional beverages, sauces, condiments and snacks. They were asked to consume a minimum of 1 drink + 1 food portion intervention supplement daily, in exchange for habitually eaten equivalent foods.

Also known as: CON
Conventional products

Eligibility Criteria

Age20 Years - 49 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Age: 20 - 49 years
  • BMI 18.5 - 30 kg/m2
  • Plasma glucose \<7 mmol/l (Not diagnosed with diabetes)
  • Plasma cholesterol \<7 mmol/l
  • Plasma TAG \<2.3 mmol/l
  • Normal liver and kidney function
  • Haemoglobin (\>110 g/l women; 140g/dl men)

You may not qualify if:

  • Having suffered a myocardial infarction/stroke in the past 12 months
  • diabetic (diagnosed or fasting glucose \> 7 mmol/l)
  • Smoking
  • On drug treatment for hyperlipidaemia, hypertension, inflammation or hypercoagulation
  • Suffering from renal or bowel disease or have a history of choleostatic liver or pancreatitis
  • Excessive alcohol consumption
  • History of alcohol abuse
  • Following a reducing diet or vegan diet
  • Taking any fish oil, fatty acid or vitamin and mineral supplements
  • Participating in intensive aerobic activity for \> 20 minutes 3 times per week
  • Food allergies
  • Anti-inflammatory usage

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Food and Nutritional Sciences, University of Reading

Reading, Berks, RG6 6AP, United Kingdom

Location

Related Publications (2)

  • Reid M, Hammersley R, Duffy M. Effects of sucrose drinks on macronutrient intake, body weight, and mood state in overweight women over 4 weeks. Appetite. 2010 Aug;55(1):130-6. doi: 10.1016/j.appet.2010.05.001. Epub 2010 May 12.

    PMID: 20470840RESULT

  • Reid M, Hammersley R, Hill AJ, Skidmore P. Long-term dietary compensation for added sugar: effects of supplementary sucrose drinks over a 4-week period. Br J Nutr. 2007 Jan;97(1):193-203. doi: 10.1017/S0007114507252705.

    PMID: 17217576RESULT

MeSH Terms

Conditions

Diabetes Mellitus, Type 2Cardiovascular DiseasesObesity

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesOverweightOvernutritionNutrition DisordersBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Prof Julie A Lovegrove, BSc, PhD, RNutr

    University of Reading

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Metabolic Nutrition

Study Record Dates

First Submitted

July 18, 2012

First Posted

July 20, 2012

Study Start

March 1, 2012

Primary Completion

March 1, 2013

Study Completion

March 1, 2013

Last Updated

December 4, 2014

Record last verified: 2014-12

Locations

GB(1)