# DIETARY INTERVENTION IN THE ELDERLY TRIAL (DIET)

> **NIH NIH R01** · WAKE FOREST UNIVERSITY · 1993 · $457,486

## Abstract

A substantial proportion (probably 30-40%) of elderly persons are being
treated with BP medications.  The  efficacy of BP drug therapy in older
patients with diastolic or combined diastolic/systolic hypertension is
well proven, but there is little doubt that such therapy can adversely
effect quality of life and the biochemical profile.  There is a
compelling rationale to (1) identify what proportion of medicated,
well-controlled elderly hypertensives can be maintained (long-term less
than 30 months) in the normotensive state following withdrawal of BP
medications, and (2) determine whether non-pharmacologic therapy can
significantly increase the proportion with successful outcome.

Nine-hundred subjects (225 in each of four centers) 65-80 years with a
SBP less than 160 and DBP less than 90 mmhg while receiving one BP
medication will be enrolled in a trial to test the efficacy of weight
loss and sodium restriction (alone and combined) in maintaining the
normotensive state-following withdrawal of antihypertensive medication.
600 overweight participants will be randomly assigned to weight loss,
sodium restriction, combined weight loss and sodium restriction, or
attention control. 300 non-overweight participants will be randomly
assigned to a sodium restriction or attention control group.  Withdrawal
of antihypertensive medications will be attempted following 6 weeks of
intervention.  The primary trial endpoint will be needed for recurrent
antihypertensive drug therapy.  Our findings may identify a
non-pharmacologic approach that provides a safe and well tolerated method
by which to discontinue antihypertensive drug therapy in the
approximately 15 million persons greater than or equal to 65 years who
are currently being treated with BP medications.  In addition, our study
will identify the proportion of elderly hypertensives who can be
maintained in the normotensive state without any intervention following
withdrawal from their BP medications.

A multidisciplinary team will function as the Data Coordinating Center
(DCC) for this trial.  It includes expertise in biostatistics, nutrition,
data management, cardiovascular disease, epidemiology and the design,
implementation and evaluation of clinical trials.  This team will
collaborate with other investigators in developing the study protocol and
manuals, developing and monitoring quality control, training, reporting,
and analyzing and publishing study results.  Clinic data will be
collected using a distributed data entry system.  Excellent facilities
exist for the DDC.

## Key facts

- **NIH application ID:** 3121683
- **Project number:** 5R01AG009773-03
- **Recipient organization:** WAKE FOREST UNIVERSITY
- **SAM.gov UEI:** MBU6HCLNZ431
- **Principal Investigator:** MARK Andrew ESPELAND
- **Activity code:** R01 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 1993
- **Award amount:** $457,486
- **Award type:** 5
- **Project period:** 1991-09-30 → 1996-02-28

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/3121683

## Citation

> US National Institutes of Health, RePORTER application 3121683, DIETARY INTERVENTION IN THE ELDERLY TRIAL (DIET) (5R01AG009773-03). Retrieved via MORVS 2026-10-25 from https://api.morvs.ai/grant/nih/3121683. Licensed CC0.

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