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HealthyNCT02355795

Diets With a Spectrum of Fat Intake for Preventing Obesity: A Randomized Controlled-feeding Trial

A study testing low-fat diet, moderate-fat diet and high-fat diet in people with Healthy, run by Zhejiang University at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The aim of the current study is to evaluate the effects of diets with three levels of dietary fat on weight change and related cardiometabolic risk factors in a 6-month randomized controlled-feeding trial. Read more about this study

Who is it for?
Ages 18 to 35 yearsHealthy volunteers can take part
Conditions the study is for
Healthy
What is being tested?
low-fat diet, moderate-fat diet and high-fat diet
Could I receive a placebo?
No, everyone receives an active treatment
How many people
307 participants
Where
1 siteChina
Study dates
Nov 2014to Oct 2015
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 35 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Students in Zhejiang University or working stuff in the Chinese PLA General Hospital
  • 18 ≤ age ≤ 35
  • Body Mass Index < 28*
  • Are willing to eat all of the study foods even when full
  • Are willing to eat only foods provided
  • Are willing to avoid strenuous activity during the 6-mo intervention Exclusion criteria：
Show all 27Show fewer
  • Systolic blood pressure ≥ 140 mmHg or diastolic blood pressure ≥ 90 mmHg
  • Total cholesterol ≥ 239 mg/dL
  • Low-density lipoprotein cholesterol ≥ 159 mg/dL
  • Triglycerides ≥ 199 mg/dL
  • Blood glucose ≥ 110 mg/dL
  • Change in body weight exceeding ± 10% during the prior year
  • Energy intake is too low or too high
  • Unwillingness or special requirement for diet that could not be modified
  • Poor adherence during the recruiting meeting or unsatisfactory completion of keeping food diary or filling questionnaire at any time before randomization
  • Eating disorder or any psychosocial or scheduling factors that could impede study outcomes
  • Have a history of diagnosed CVD, diabetes, cancer or inflammatory diseases
  • Have a history of a mental illness
  • Have diagnosed endocrine, pulmonary or hematological disease
  • Have diagnosed bowel disease or malabsorption that would prevent the participants from complying with the dietary restrictions of the feeding trial
  • Renal or liver insufficiency
  • Other chronic disease thought to interfere with the effect of the diet or with participation or adherence
  • Current use of supplements or anti-inflammation medications or medications affecting glucose, lipid metabolism and blood pressure
  • Smoking or alcoholic beverage intake >1 times per week
  • Current or planned pregnancy prior to end of study, or breast-feeding
  • Irregular menstrual cycles
  • Have birth control medication

Who cannot join

None listed.

Trial locations and contacts

1 site in 1 country.

China1 site

  • Zhejiang University

    Hangzhou, Zhejiang, 310058

Other trials in China

About this study

The aim of the current study is to evaluate the effects of diets with three levels of dietary fat on weight change and related cardiometabolic risk factors in a 6-month randomized controlled-feeding trial.

Conditions
Healthy
Being tested
low-fat diet, moderate-fat diet, high-fat diet
Keywords
weight change, diet, dietary fat, feeding design
Medical subject headings
Body Weight Changes

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • low-fat dietBehavioural

    Energy from total fat, protein and carbohydrates are 20%, 14% and 66%, respectively

  • moderate-fat dietBehavioural

    Energy from total fat, protein and carbohydrates are 30%, 14% and 56%, respectively

  • high-fat dietBehavioural

    Energy from total fat, protein and carbohydrates are 40%, 14% and 46%, respectively

Study groups in NCT02355795
Study groupRoleWhat they receive
low-fat dietExperimentalParticipants will be provided low-fat diet for 6 months
Receives: Behavioral: low-fat diet
moderate-fat dietExperimentalParticipants will be provided moderate-fat diet for 6 months
Receives: Behavioral: moderate-fat diet
high-fat dietExperimentalParticipants will be provided high-fat diet for 6 months
Receives: Behavioral: high-fat diet

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. body weight in kilograms as measured by a calibrated scale

    change from baseline will be reported

    Measured: 0,1,2,3,4,5,and 6 months

Secondary outcomes (5)

  1. waist circumference as measured by an anthropometric measuring tape

    change from baseline will be reported

    Measured: 0,1,2,3,4,5,and 6 months

  2. blood pressure as measured by a validated automated sphygmomanometer

    change from baseline will be reported

    Measured: 0,1,2,3,4,5,and 6 months

  3. fasting blood lipids as measured by a clinical chemistry analyzer

    change from baseline will be reported

    Measured: 0,1,2,3,4,5,and 6 months

  4. fasting glucose, insulin, glycated serum protein as measured by an immunology analyzer

    change from baseline will be reported

    Measured: 0,1,2,3,4,5,and 6 months

  5. adiponectin, leptin as measured by ELISA kits

    change from baseline will be reported

    Measured: 0,1,2,3,4,5,and 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Feb 2015 (estimated)
  2. Study startNov 2014
  3. Primary completionOct 2015

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
307 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02355795
Sponsor's protocol ID
DUOLI201501
Status last verified
Nov 2016
First submitted
25 Jan 2015
Last updated
28 Nov 2016
Results posted
No

Publications

  • Wan Y, Yuan J, Li J, Li H, Zhang J, Tang J, Ni Y, Huang T, Wang F, Zhao F, Li D. Unconjugated and secondary bile acid profiles in response to higher-fat, lower-carbohydrate diet and associated with related gut microbiota: A 6-month randomized controlled-feeding trial. Clin Nutr. 2020 Feb;39(2):395-404. doi: 10.1016/j.clnu.2019.02.037. Epub 2019 Feb 27.

    PubMed 30876827

  • Wan Y, Wang F, Yuan J, Li J, Jiang D, Zhang J, Li H, Wang R, Tang J, Huang T, Zheng J, Sinclair AJ, Mann J, Li D. Effects of dietary fat on gut microbiota and faecal metabolites, and their relationship with cardiometabolic risk factors: a 6-month randomised controlled-feeding trial. Gut. 2019 Aug;68(8):1417-1429. doi: 10.1136/gutjnl-2018-317609. Epub 2019 Feb 19.

    PubMed 30782617

  • Wan Y, Wang F, Yuan J, Li J, Jiang D, Zhang J, Huang T, Zheng J, Mann J, Li D. Effects of Macronutrient Distribution on Weight and Related Cardiometabolic Profile in Healthy Non-Obese Chinese: A 6-month, Randomized Controlled-Feeding Trial. EBioMedicine. 2017 Aug;22:200-207. doi: 10.1016/j.ebiom.2017.06.017. Epub 2017 Jun 20.

    PubMed 28655596

Questions about this trial

What is this clinical trial studying?

A study testing low-fat diet, moderate-fat diet and high-fat diet in people with Healthy, run by Zhejiang University at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 27 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 28 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

body weight in kilograms as measured by a calibrated scale (time frame: 0,1,2,3,4,5,and 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02355795, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Nov 2016.

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