NCT04804397

Brief Summary

Background: Sugar intake, especially in liquid, correlates with obesity. Yet, whether it is a special cause of obesity is less clear. Few experimental studies exist. Aim: To replicate the investigators' previous 4 week experiments on women with men over 8 weeks to ascertain if: they gain weight given sucrose soft drinks; mood is affected; energy intake is affected. Participants: 80 men BMI 25-35, aged 30-55. Procedure: After a week of baseline, over eight weeks single blind 40 men received soft drinks containing sucrose (1650 KJ, 97g carbohydrate per day), 40 received control drinks. A three-day food diary with mood ratings and activity levels was completed during baseline and weeks 1, 4 and 8 of the experiment. Body mass was recorded weekly with other anthropometric measures.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Aug 2010

Typical duration for not_applicable

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

August 1, 2010

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2013

Completed
2.7 years until next milestone

First Submitted

Initial submission to the registry

January 26, 2016

Completed
5.1 years until next milestone

First Posted

Study publicly available on registry

March 18, 2021

Completed
Last Updated

March 18, 2021

Status Verified

March 1, 2021

Enrollment Period

2.8 years

First QC Date

January 26, 2016

Last Update Submit

March 15, 2021

Conditions

Keywords

SucroseSugarCarbohydrateWeight gainmen

Outcome Measures

Primary Outcomes (1)

  • Body Mass

    Do participants gain weight?

    Eight Weeks

Secondary Outcomes (2)

  • Daily energy intake assessed by free-living unweighed food diary

    Eight Weeks

  • Mood assessed using 10 rating scales

    Eight Weeks

Study Arms (2)

Sucrose

EXPERIMENTAL

Sucrose: 1l sucrose sweetened soft drink per day for 8 weeks (1650 KJ, 97g carbohydrate per day) as 4 25cl drinks

Dietary Supplement: Sucrose

Aspartame

PLACEBO COMPARATOR

Aspartame: 1l aspartame sweetened soft drink per day for 8 weeks as 4 25cl drinks

Dietary Supplement: Sucrose

Interventions

SucroseDIETARY_SUPPLEMENT

Sucrose sweetened soft drinks

Also known as: Aspartame, Aspartame sweetened soft drinks as comparator
AspartameSucrose

Eligibility Criteria

Age30 Years - 55 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • BMI 25-35

You may not qualify if:

  • Diabetes,
  • other health problems,
  • medication,
  • dislike of soft drinks

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

OverweightWeight GainMultiple Endocrine Neoplasia Type 1

Interventions

SucroseAspartame

Condition Hierarchy (Ancestors)

OvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsBody Weight ChangesMultiple Endocrine NeoplasiaEndocrine Gland NeoplasmsNeoplasms by SiteNeoplasmsNeoplasms, Multiple PrimaryNeoplastic Syndromes, HereditaryGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

DisaccharidesOligosaccharidesPolysaccharidesCarbohydratesSugarsDipeptidesOligopeptidesPeptidesAmino Acids, Peptides, and Proteins

Study Officials

  • Richard Hammersley, PhD

    University of Hull

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Health Psychology

Study Record Dates

First Submitted

January 26, 2016

First Posted

March 18, 2021

Study Start

August 1, 2010

Primary Completion

June 1, 2013

Study Completion

June 1, 2013

Last Updated

March 18, 2021

Record last verified: 2021-03

Data Sharing

IPD Sharing
Will not share