NCT03729479

Brief Summary

This study will compare the low-sodium/low-fat DASH (Dietary Approaches to Stop Hypertension) diet with a very low-carbohydrate diet, helping us to better understand how two different dietary approaches may help participants control their blood pressure, lose weight, and reduce their blood glucose.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
94

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Nov 2018

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

First Submitted

Initial submission to the registry

October 31, 2018

Completed
1 day until next milestone

Study Start

First participant enrolled

November 1, 2018

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 2, 2018

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 9, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 9, 2020

Completed
Last Updated

September 29, 2020

Status Verified

September 1, 2020

Enrollment Period

1.8 years

First QC Date

October 31, 2018

Last Update Submit

September 28, 2020

Conditions

Type2 Diabetes MellitusHypertensionPreDiabetesOverweight and Obesity

Keywords

dietary intervention

Outcome Measures

Primary Outcomes (1)

  • Systolic blood pressure

    Measured with sphygmomanometer, assessed as change in blood pressure (systolic and diastolic blood pressure will both be measured, but systolic blood pressure is the main outcome)

    4 months

Secondary Outcomes (2)

  • Glycemic control

    4 months

  • Weight loss

    4 months

Study Arms (4)

Experimental: DASH diet

EXPERIMENTAL

Participants will be taught to follow a DASH diet (low-sodium and low-fat meal plan, which includes whole grains, fat-free or low-fat dairy products, vegetables, fruits, poultry, fish, and nuts, with processed, high-sodium, regular-fat, and sugar-added foods restricted).

Behavioral: DASH diet

Experimental: very low carbohydrate, ketogenic diet

EXPERIMENTAL

Participants will be taught to follow a very low-carbohydrate, ketogenic diet (non-starchy vegetables, nuts, seeds, meat, fish, and natural fats such as avocado, olive oil, and butter, with starchy and sugary foods restricted).

Behavioral: Very low carbohydrate, ketogenic diet

Experimental: DASH diet and extra support

EXPERIMENTAL

Participants will be taught to follow a DASH diet (low-sodium and low-fat meal plan, which includes whole grains, fat-free or low-fat dairy products, vegetables, fruits, poultry, fish, and nuts, with processed, high-sodium, regular-fat, and sugar-added foods restricted). They will also be given training in positive affect, mindfulness, health information seeking and sharing, and cooking practices and behavior.

Behavioral: DASH dietBehavioral: Extras

Experimental: very low carb, ketogenic diet and extra support

EXPERIMENTAL

Participants will be taught to follow a very low-carbohydrate, ketogenic diet (non-starchy vegetables, nuts, seeds, meat, fish, and natural fats such as avocado, olive oil, and butter, with starchy and sugary foods restricted). They will also be given training in positive affect, mindfulness, health information seeking and sharing, and cooking practices and behavior.

Behavioral: Very low carbohydrate, ketogenic dietBehavioral: Extras

Interventions

DASH dietBEHAVIORAL

Participants will be taught to follow a DASH diet (low-sodium and low-fat meal plan, which includes whole grains, fat-free or low-fat dairy products, vegetables, fruits, poultry, fish, and nuts, with processed, high-sodium, regular-fat, and sugar-added foods restricted).

Experimental: DASH dietExperimental: DASH diet and extra support
Very low carbohydrate, ketogenic dietBEHAVIORAL

Participants will be taught to follow a very low-carbohydrate diet (non-starchy vegetables, nuts, seeds, meat, fish, and natural fats such as avocado, olive oil, and butter, with starchy and sugary foods restricted).

Experimental: very low carb, ketogenic diet and extra supportExperimental: very low carbohydrate, ketogenic diet
ExtrasBEHAVIORAL

Participants will be given training in positive affect, mindfulness, health information seeking and sharing, and cooking practices and behavior.

Experimental: DASH diet and extra supportExperimental: very low carb, ketogenic diet and extra support

Eligibility Criteria

Age21 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • BMI of 25-50
  • Diagnosis pre-hypertension or hypertension (within the past 6 months) and current resting systolic blood pressure \> 130 mmHg.
  • Diagnosis of either prediabetes or type 2 diabetes, defined as:
  • HbA1c of at least 5.7% or
  • Two-hour glucose tolerance test \>140 mg/dL
  • Aged 21-70 years old
  • Access to the internet and text messaging
  • Ability to engage in light physical activity
  • Sufficient control over their food intake to adhere to study diets
  • Willingness to regularly monitor blood pressure, glucose, dietary intake, and body weight over 4-month trial
  • Participation in the trial approved by primary care provider, along with agreement to work with the participant and our research team to manage medication changes

You may not qualify if:

  • Non-English speaking
  • Current use of insulin, Dilantin, lithium, and warfarin
  • Inability to complete baseline measurements
  • Severe renal or hepatic insufficiency
  • Cardiovascular dysfunction, including diagnosis of:
  • Congestive heart failure
  • Angina
  • Arrhythmias
  • Cardiomyopathy
  • Valvular heart disease
  • Uncontrolled psychiatric disorder
  • Consumes \>30 alcoholic drinks per week
  • Currently undergoing chemotherapy
  • Pregnant or planning to get pregnant in the next 12 months
  • Breastfeeding or less than 6 months' post-partum
  • +5 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

Related Publications (1)

  • Saslow LR, Jones LM, Sen A, Wolfson JA, Diez HL, O'Brien A, Leung CW, Bayandorian H, Daubenmier J, Missel AL, Richardson C. Comparing Very Low-Carbohydrate vs DASH Diets for Overweight or Obese Adults With Hypertension and Prediabetes or Type 2 Diabetes: A Randomized Trial. Ann Fam Med. 2023 May-Jun;21(3):256-263. doi: 10.1370/afm.2968.

    PMID: 37217318DERIVED

MeSH Terms

Conditions

HypertensionPrediabetic StateOverweightObesity

Interventions

Dietary Approaches To Stop HypertensionDiet, Ketogenic

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular DiseasesDiabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesOvernutritionNutrition DisordersBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Diet TherapyNutrition TherapyTherapeuticsDietNutritional Physiological PhenomenaDiet, Food, and NutritionPhysiological PhenomenaDiet, Carbohydrate-Restricted

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
FACTORIAL
Model Details: 2x2 full factorial
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

October 31, 2018

First Posted

November 2, 2018

Study Start

November 1, 2018

Primary Completion

August 9, 2020

Study Completion

August 9, 2020

Last Updated

September 29, 2020

Record last verified: 2020-09

Data Sharing

IPD Sharing
Will not share

Locations

US(1)