Effects of Sucrose Added Blind to the Diet Over Eight Weeks on Body Mass and Weight in Men
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| ClinicalTrials.gov Identifier: NCT04804397 |
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Recruitment Status :
Completed
First Posted : March 18, 2021
Last Update Posted : March 18, 2021
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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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Overweight | Dietary Supplement: Sucrose | Not Applicable |
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 80 participants |
| Allocation: | Non-Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Single (Participant) |
| Primary Purpose: | Basic Science |
| Official Title: | Effects of Sucrose Added Blind to the Diet Over Eight Weeks on Body Mass and Weight in Men |
| Study Start Date : | August 2010 |
| Actual Primary Completion Date : | June 2013 |
| Actual Study Completion Date : | June 2013 |
| Arm | Intervention/treatment |
|---|---|
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Experimental: Sucrose
Sucrose: 1l sucrose sweetened soft drink per day for 8 weeks (1650 KJ, 97g carbohydrate per day) as 4 25cl drinks
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Dietary Supplement: Sucrose
Sucrose sweetened soft drinks
Other Names:
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Placebo Comparator: Aspartame
Aspartame: 1l aspartame sweetened soft drink per day for 8 weeks as 4 25cl drinks
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Dietary Supplement: Sucrose
Sucrose sweetened soft drinks
Other Names:
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- Body Mass [ Time Frame: Eight Weeks ]Do participants gain weight?
- Daily energy intake assessed by free-living unweighed food diary [ Time Frame: Eight Weeks ]Do participants eat less to compensate for added sucrose?
- Mood assessed using 10 rating scales [ Time Frame: Eight Weeks ]Are there changes in rated mood during sucrose supplementation?
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| Ages Eligible for Study: | 30 Years to 55 Years (Adult) |
| Sexes Eligible for Study: | Male |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- BMI 25-35
Exclusion Criteria:
- Diabetes,
- other health problems,
- medication,
- dislike of soft drinks
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04804397
| Study Chair: | Richard Hammersley, PhD | University of Hull |
| Responsible Party: | Richard Hammersley, Professor of Health Psychology, University of Hull |
| ClinicalTrials.gov Identifier: | NCT04804397 |
| Other Study ID Numbers: |
PSY4272 |
| First Posted: | March 18, 2021 Key Record Dates |
| Last Update Posted: | March 18, 2021 |
| Last Verified: | March 2021 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
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Sucrose Sugar Carbohydrate Weight gain men |
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Overweight Body Weight |

