NCT01640015

Brief Summary

The primary purpose of this study is to identify the effect of meal frequency on blood pressure (BP) levels of individuals.

Trial Health

30
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Timeline
Completed

Started Jan 2012

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
withdrawn

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

January 1, 2012

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2012

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2012

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

July 11, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 13, 2012

Completed
Last Updated

April 17, 2019

Status Verified

April 1, 2019

Enrollment Period

Same day

First QC Date

July 11, 2012

Last Update Submit

April 16, 2019

Conditions

Blood Pressure

Keywords

Blood pressureeating episodeeating frequencyinsulin sensitivity

Outcome Measures

Primary Outcomes (1)

  • blood pressure

    Participants will be asked to wear BP monitor continuously for one week then return it back either by post or bring it themselves to the center.

    2 weeks for 24 hours through blood pressure monitor

Secondary Outcomes (1)

  • Insulin

    measured twice during each phase (2 phases)

Study Arms (2)

low frequency diet

EXPERIMENTAL

Participants will be assigned to a low frequency diet (fixed energy intake)

Other: dietary intervention

High frequency diet

EXPERIMENTAL
Other: dietary intervention

Interventions

dietary interventionOTHER

a low frequency diet (3 meals/day) a high frequency diet (9 meals/day)

High frequency dietlow frequency diet

Eligibility Criteria

Age35 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Healthy individuals aged 35-70 years with prehypertension (systolic/diastolic BP 120-139/80-89 mm Hg) BMI 20-30 kg/m2 non-smoking non alcoholic drinkers

You may not qualify if:

  • Weight change of ≥ 3kg in the preceding 2 months
  • Current smokers
  • Substance abuse
  • Alcohol intake
  • Pregnancy
  • Diabetes
  • Cardiovascular disease
  • Cancer
  • Gastrointestinal disease e.g. inflammatory bowel disease or irritable bowel syndrome
  • Kidney disease
  • Liver disease
  • Pancreatitis
  • Use of medications including: anti inflammatory drugs or steroids, antihypertensive drugs, cholesterol lowering medication, androgens, phenytoin, erythromycin or thyroid hormones.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sir John Michael Center - Hammersmith Hospital

London, w2, United Kingdom

Location

MeSH Terms

Conditions

Insulin Resistance

Interventions

Diet Therapy

Condition Hierarchy (Ancestors)

HyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Nutrition TherapyTherapeutics
0

Study Design

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

Study Record Dates

First Submitted

July 11, 2012

First Posted

July 13, 2012

Study Start

January 1, 2012

Primary Completion

January 1, 2012

Study Completion

March 1, 2012

Last Updated

April 17, 2019

Record last verified: 2019-04

Locations

GB(1)